Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen

A Prospective, Multicenter, 12-week, Randomized Open-label Study to Evaluate the Efficacy and Safety of Glycopyrronium (50 Micrograms o.d.) or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination (110/50 Micrograms o.d.) Regarding Symptoms and Health Status in Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD) Switching From Treatment With Any Standard COPD Regimen

The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients with moderate COPD who switch from their current COPD therapy. This study aims to provide data on how non-exacerbating, but still symptomatic patients with moderate COPD switching from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study is to increase awareness and usage of validated COPD symptoms tools and dyspnea questionnaires in order to facilitate clinical assessment and improve early diagnosis of symptomatic patients.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Drug: Glycopyrronium; Drug: SABA; Drug: SAMA; Drug: LABA; Drug: Indacaterol maleate and glycopyrronium bromide; Drug: LAMA; Drug: ICS

Detailed Description

The treatment epoch will last 12 weeks. The total duration of the study for each patient is 12 weeks (from randomization) plus 30 days of safety follow-up.

The study has three phases: screening phase (=wash-out period, if required), treatment phase and safety follow-up phase.

Eligible patients will be randomized to either receive glycopyrronium or indacaterol maleate and glycopyrronium bromide fixed dose combination or to remain in their baseline therapy, in an allocation ratio of 3:1 for each cluster (Groups A, B, C, and D), based on their COPD symptoms and baseline treatment:

Group A: Patients treated with any SABA ( Short-acting β2-adrenergic agonist) and/or SAMA (Short-acting muscarinic antagonist) as monotherapy or in free or fixed dose combination (FDC) will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) Group B: Patients treated with any LABA (Long-acting β2-adrenergic agonist) or LAMA (Long-acting muscarinic antagonist) monotherapy and mMRC score =1 point will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) Group C: Patients treated with any LABA and ICS (Inhaled corticosteroid) in free or FDC will be assigned to indacaterol maleate and glycopyrronium bromide fixed dose combination or will remain in their baseline therapy (3:1) Group D: Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point will be assigned to indacaterol maleate and glycopyrronium bromide fixed dose combination or will remain in their baseline therapy (3:1) Due to low recruitment in Groups A and B that would lead to a significant delay of trial completion, a protocol amendment was made in order to close the recruitment of Groups A and B at the time the randomization in Groups C and D would be completed. Recruitment of the Groups C and D continued as originally planned

• Study Type: Interventional
• Enrollment (Actual): 4389
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Amstetten, Austria, 3300
    • Novartis Investigative Site
  • Feldkirch, Austria, 6800
    • Novartis Investigative Site
  • Hallein, Austria, 5400
    • Novartis Investigative Site
  • Kirchdorf an der Krems, Austria, 4560
    • Novartis Investigative Site
  • Leoben, Austria, 8700
    • Novartis Investigative Site
  • Linz, Austria, 4020
    • Novartis Investigative Site
  • Perg, Austria, 4320
    • Novartis Investigative Site
  • Salzburg, Austria, 5020
    • Novartis Investigative Site
  • Wels, Austria, 4600
    • Novartis Investigative Site
• Belgium
  • Antwerpen, Belgium, 2060
    • Novartis Investigative Site
  • Balen, Belgium, 2490
    • Novartis Investigative Site
  • Braine l'Alleud, Belgium, 1420
    • Novartis Investigative Site
  • Brussels, Belgium, 1070
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  • Bruxelles, Belgium, 1200
    • Novartis Investigative Site
  • Bruxelles, Belgium, 1000
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  • Eghezee, Belgium, 5310
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  • Erpent, Belgium, 5100
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  • Geraardsbergen, Belgium, 9500
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  • Gilly, Belgium, 6060
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  • Halen, Belgium, 3545
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  • Hasselt, Belgium, 3500
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  • Heusy, Belgium, 4802
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  • Ieper, Belgium, 8900
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  • Knokke-Heist, Belgium, 8300
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  • Lebbeke, Belgium, 9280
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  • Liege, Belgium, 4000
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  • Maaseik, Belgium, 3680
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  • Malmedy, Belgium, 4960
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  • Mechelen, Belgium, 2800
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  • Melsbroek, Belgium, 1820
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  • Merksem, Belgium, 2170
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  • Montegnée, Belgium, 4420
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  • Natoye, Belgium, 5360
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  • Paal-Beringen, Belgium, 3583
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  • Ronse, Belgium, 9600
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  • Saint-Medard, Belgium, 6887
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  • Seraing, Belgium, 4100
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  • Tournai, Belgium, 7500
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  • Verviers, Belgium, 4800
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  • Vilvoorde, Belgium, 1800
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  • Zottegem, Belgium, 9620
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  • BEL
    • Gosselies, BEL, Belgium, 6041
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    • Gozee, BEL, Belgium, 6534
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    • Zichem, BEL, Belgium, 3271
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• Czechia
  • Praha 8, Czechia, 182 00
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  • Czech Republic
    • Boskovice, Czech Republic, Czechia, 680 01
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    • Brandys Nad Labem, Czech Republic, Czechia, 25001
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    • Brno-Kralovo Pole, Czech Republic, Czechia, 61200
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    • Cvikov, Czech Republic, Czechia, 471 54
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    • Havlickuv Brod, Czech Republic, Czechia, 580 01
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    • Jirkov, Czech Republic, Czechia, 43111
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    • Kurim, Czech Republic, Czechia, 66434
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    • Liberec, Czech Republic, Czechia, 460 01
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    • Lovosice, Czech Republic, Czechia, 410 02
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    • Neratovice, Czech Republic, Czechia, 27711
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    • Ostrava, Czech Republic, Czechia, 708 68
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    • Pardubice, Czech Republic, Czechia, 530 09
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    • Plzen, Czech Republic, Czechia, 33011
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    • Plzen, Czech Republic, Czechia, 331 01
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    • Prague, Czech Republic, Czechia, 130 00
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    • Prague 4, Czech Republic, Czechia, 142 00
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    • Praha, Czech Republic, Czechia, 14800
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    • Praha 10, Czech Republic, Czechia, 108 00
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    • Praha 4, Czech Republic, Czechia, 140 46
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    • Praha 6, Czech Republic, Czechia, 163 00
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    • Praha 9, Czech Republic, Czechia, 19000
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    • Rokycany, Czech Republic, Czechia, 337 22
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    • Rudna, Czech Republic, Czechia, 25219
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    • Teplice, Czech Republic, Czechia, 415 01
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    • Trebic, Czech Republic, Czechia, 674 01
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    • Varnsdorf, Czech Republic, Czechia, 40747
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    • Zatec, Czech Republic, Czechia, 438 01
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    • Znojmo, Czech Republic, Czechia, 672 01
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• Denmark
  • Alleroed, Denmark, 3450
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  • Greve, Denmark, 2670
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  • Haslev, Denmark, 4690
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  • Søborg, Denmark, 2860
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  • Værløse, Denmark, 3500
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• Estonia
  • Paide, Estonia, 72714
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  • Tallinn, Estonia, 13419
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  • Tallinn, Estonia, 10617
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  • Tallinn, Estonia, 10138
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  • Tallinn, Estonia, 13619
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  • Tartu, Estonia, 51014
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• France
  • Briis Sous Forges, France, 91640
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  • Chamalieres, France, 63400
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  • Chatellerault, France, 86100
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  • Forbach, France, 57600
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  • L'Aigle, France, 61305
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  • La Bouexiere, France, 35340
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  • Marseille, France, 13003
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  • Montpellier, France, 34080
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  • Murs Erigne, France, 49610
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  • Nice, France, 06000
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  • Saint Jean de Luz, France, 64500
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  • Saint Laurent Du Var, France, 06721
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  • Saint Pierre, France, 97448
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  • Strasbourg, France, 67000
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  • Toulon, France, 83000
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  • Indre Et Loire
    • Tours Cedex 9, Indre Et Loire, France, 37044
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• Germany
  • Annaberg-Buchholz, Germany, 09456
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  • Auerbach, Germany, 08209
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  • Augsburg, Germany, 86150
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  • Bad Neustadt, Germany, 97616
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  • Bad Salzuflen, Germany, 32105
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  • Bad Woerishofen, Germany, 86825
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  • Bamberg, Germany, 96049
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  • Bensheim, Germany, 64625
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  • Berlin, Germany, 12203
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  • Berlin, Germany, 12687
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  • Berlin, Germany, 13086
    • Novartis Investigative Site
  • Berlin, Germany, 10717
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  • Berlin, Germany, 10117
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  • Berlin, Germany, 10367
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  • Berlin, Germany, 12627
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  • Berlin, Germany, 13156
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  • Berlin, Germany, 10787
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  • Berlin, Germany, 12165
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  • Berlin, Germany, D-12165
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  • Berlin, Germany, 12157
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  • Berlin, Germany, 14059
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  • Berlin, Germany, 12159
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  • Berlin, Germany, 10119
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  • Berlin, Germany, 12099
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  • Berlin, Germany, 13057
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  • Berlin, Germany, 13507
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  • Berlin, Germany, 13187
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  • Berlin, Germany, 10629
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  • Berlin, Germany, 10625
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  • Bielefeld, Germany, 33617
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  • Bochum, Germany, 44787
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  • Bonn, Germany, 53119
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  • Bonn, Germany, 53123
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  • Bottrop, Germany, 46240
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  • Bruchsal, Germany, 76646
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  • Burgwedel, Germany, 30938
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  • Daaden, Germany, 57567
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  • Dachau, Germany, 85221
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  • Deggendorf, Germany, 94469
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  • Deggingen, Germany, 73328
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  • Delitzsch, Germany, 04509
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  • Dortmund, Germany, 44263
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  • Dresden, Germany, 01069
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  • Dresden, Germany, 01129
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  • Dueren, Germany, 52349
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  • Dusseldorf, Germany, 40489
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  • Düsseldorf, Germany, 40211
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  • Eisenach, Germany, 99817
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  • Elsterwerda, Germany, 04910
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  • Erlangen, Germany, 91054
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  • Essen, Germany, 45147
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  • Essen, Germany, 45277
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  • Essen, Germany, 45276
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  • Essen, Germany, 45355
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  • Essen, Germany, 45359
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  • Essen, Germany, 45138
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  • Foehren, Germany, 54343
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  • Frankenberg (Eder), Germany, 35066
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  • Frankfurt, Germany, 60389
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  • Frankfurt am Main, Germany, 60313
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  • Freiburg, Germany, 79104
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  • Freudenberg, Germany, 57258
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  • Furstenwalde, Germany, 15517
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  • Fürstenwalde/Spree, Germany, 15517
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  • Garmisch-Partenkirchen, Germany, 82467
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  • Gauting, Germany, 82131
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  • Gießen, Germany, 35390
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  • Gifhorn, Germany, 38518
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  • Goch, Germany, 47574
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  • Goerlitz, Germany, 02826
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  • Gummersbach, Germany, 51343
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  • Gütersloh, Germany, 33330
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  • Hagen, Germany, 58089
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  • Halberstadt, Germany, 38820
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  • Halle, Germany, 06108
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  • Hamburg, Germany, 20354
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  • Hamburg, Germany, 20357
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  • Hamburg, Germany, 20253
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  • Hamburg, Germany, 22299
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  • Hamburg, Germany, 22143
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  • Hamburg, Germany, 22335
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  • Hamburg, Germany, 22527
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  • Hannover, Germany, 30173
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  • Hannover, Germany, 30163
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  • Hannover, Germany, 30419
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  • Heidelberg, Germany, 69117
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  • Hettstedt, Germany, 06333
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  • Hildesheim, Germany, 31134
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  • Hoyerswerda, Germany, 02977
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  • Jena, Germany, 07740
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  • Jerichow, Germany, 39319
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  • Kamen, Germany, 59174
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  • Karlsruhe, Germany, 76199
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  • Kassel, Germany, 34121
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  • Kassel, Germany, 34117
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  • Kiel, Germany, 24105
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  • Kleve, Germany, 47533
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  • Koeln, Germany, 50937
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  • Koeln, Germany, 51069
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  • Koeln, Germany, 50668
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  • Koeln, Germany, 51605
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  • Köthen, Germany, 06366
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  • Landau-Pfalz, Germany, 76829
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  • Landsberg, Germany, 86899
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  • Leipzig, Germany, 04207
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  • Leipzig, Germany, 04357
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  • Leipzig, Germany, 04103
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  • Leipzig, Germany, 04275
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  • Leipzig, Germany, 04109
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  • Leonberg, Germany, 71229
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  • Leverkusen, Germany, 51379
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  • Limburgerhof, Germany, 67117
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  • Loehne, Germany, 32584
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  • Ludwigsburg, Germany, 71640
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  • Ludwigshafen, Germany, 67067
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  • Ludwigshafen, Germany, 67061
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  • Luedenscheid, Germany, 58507
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  • Lübeck, Germany, 23554
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  • Magdeburg, Germany, 39112
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  • Marburg, Germany, D-35037
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  • Marburg, Germany, 35037
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  • Marburg, Germany, 35033
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  • Mayen, Germany, 56727
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  • Meine, Germany, 38527
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  • Meissen, Germany, 01662
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  • Menden, Germany, 58706
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  • Minden, Germany, 32423
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  • Mittweida, Germany, 09648
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  • Mülheim, Germany, 45468
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  • München, Germany, 80335
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  • München, Germany, 80802
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  • Münnerstadt, Germany, 97702
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  • Neu Isenburg, Germany, 63263
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  • Neu-Ulm, Germany, 89231
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  • Neunkirchen, Germany, 66539
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  • Neuss, Germany, 41462
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  • Neuwied, Germany, 56564
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  • Northeim, Germany, 37154
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  • Nürnberg, Germany, 90443
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  • Nürnberg, Germany, 90478
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  • Obermichelbach, Germany, 90587
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  • Oschatz, Germany, 04758
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  • Oschersleben, Germany, 39387
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  • Osnabrueck, Germany, 49074
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  • Papenburg, Germany, 26871
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  • Passau, Germany, 94032
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  • Plauen, Germany, 08523
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  • Potsdam, Germany, 14467
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  • Potsdam, Germany, 14469
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  • Prien A. Chiemsee, Germany, 83209
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  • Radebeul, Germany, 01445
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  • Ratingen, Germany, 40878
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  • Raubach, Germany, 56316
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  • Reinfeld, Germany, 23858
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  • Rheine, Germany, 48431
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  • Rodenbach, Germany, 67688
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  • Roth, Germany, 91154
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  • Rudersdorf, Germany, 15562
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  • Rüsselsheim, Germany, 65428
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  • Rüsselsheim,, Germany, 65428
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  • Saalfeld, Germany, 07318
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  • Saarbruecken, Germany, 66111
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  • Schleswig, Germany, 24837
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  • Schwabach, Germany, 91126
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  • Schwedt, Germany, 16303
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  • Schwerin, Germany, 19055
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  • Schwetzingen, Germany, 68723
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  • Siegen, Germany, 57076
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  • Sinsheim, Germany, 74889
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  • Solingen, Germany, 42651
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  • Solingen, Germany, 42665
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  • Solingen, Germany, 42697
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  • Sonneberg, Germany, 96515
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  • Strausberg, Germany, 15344
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  • Teuchern, Germany, 06682
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  • Ulm, Germany, 89073
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  • Wardenburg, Germany, 26203
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  • Weilheim, Germany, 82362
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  • Welzheim, Germany, 73642
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  • Westerkappeln, Germany, 49492
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  • Wiesloch, Germany, 69168
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  • Wissen, Germany, 57537
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  • Witten, Germany, 58452
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  • Woellstein, Germany, 55597
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  • Wolfsburg, Germany, 38448
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  • Zerbst, Germany, 39261
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  • NRW
    • Koblenz, NRW, Germany, 56068
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  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30159
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    • Peine, Niedersachsen, Germany, 31224
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  • Nordrhein-Westfalen
    • Warendorf, Nordrhein-Westfalen, Germany, 48231
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  • Rheinland Pfalz
    • Essen, Rheinland Pfalz, Germany, 45127
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  • Sachsen
    • Cottbus, Sachsen, Germany, 03050
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  • Schleswig Holstein
    • Geesthacht, Schleswig Holstein, Germany, 12502
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• Greece
  • Serres, Greece, GR 62 100
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  • GR
    • Athens, GR, Greece, 115 27
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    • Thessaloniki, GR, Greece, 564 29
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• Hungary
  • Cegled, Hungary, 2700
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  • Debrecen, Hungary, 4026
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  • Hatvan, Hungary, 3000
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  • Komarom, Hungary, 2900
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  • Mako, Hungary, 6900
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  • Mateszalka, Hungary, 4700
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  • Pecs, Hungary, 7635
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  • Pecs, Hungary, 7624
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  • Szeged, Hungary, 6722
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  • Tatabanya, Hungary, 2800
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  • Torokbalint, Hungary, 2045
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  • HUN
    • Gyor, HUN, Hungary, 9024
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    • Szazhalombatta, HUN, Hungary, 2440
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• Ireland
  • County Limerick, Ireland, V94 F858
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  • Dublin, Ireland, 24
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  • Dublin, Ireland, DUBLIN 8
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  • Dublin 7, Ireland
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• Italy
  • Napoli, Italy, 80131
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  • Torino, Italy, 10149
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  • AN
    • Ancona, AN, Italy, 60128
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  • AV
    • Avellino, AV, Italy, 83100
      • Novartis Investigative Site
  • BA
    • Bari, BA, Italy, 70124
      • Novartis Investigative Site
    • Bari, BA, Italy, 70123
      • Novartis Investigative Site
    • Terlizzi, BA, Italy, 70038
      • Novartis Investigative Site
    • Triggiano, BA, Italy, 70019
      • Novartis Investigative Site
  • BG
    • Romano di Lombardia, BG, Italy, 24058
      • Novartis Investigative Site
  • BL
    • Feltre, BL, Italy, 32032
      • Novartis Investigative Site
  • BN
    • Telese Terme, BN, Italy, 82037
      • Novartis Investigative Site
  • BR
    • San Pietro Vernotico, BR, Italy, 72027
      • Novartis Investigative Site
  • BS
    • Brescia, BS, Italy, 25123
      • Novartis Investigative Site
  • CB
    • Campobasso, CB, Italy, 86100
      • Novartis Investigative Site
  • CE
    • Marcianise, CE, Italy, 81025
      • Novartis Investigative Site
  • CL
    • Caltanissetta, CL, Italy, 93100
      • Novartis Investigative Site
  • CN
    • Saluzzo, CN, Italy, 12037
      • Novartis Investigative Site
  • CT
    • Catania, CT, Italy, 95100
      • Novartis Investigative Site
    • Catania, CT, Italy, 95122
      • Novartis Investigative Site
    • Catania, CT, Italy, 95126
      • Novartis Investigative Site
  • FC
    • Forlì, FC, Italy, 47100
      • Novartis Investigative Site
  • FG
    • Foggia, FG, Italy, 71100
      • Novartis Investigative Site
    • San Severo, FG, Italy, 71016
      • Novartis Investigative Site
  • FI
    • Firenze, FI, Italy, 50134
      • Novartis Investigative Site
    • Firenze, FI, Italy, 50122
      • Novartis Investigative Site
  • GE
    • Genova, GE, Italy, 16100
      • Novartis Investigative Site
  • LI
    • Livorno, LI, Italy, 57124
      • Novartis Investigative Site
  • LO
    • Lodi, LO, Italy, 26900
      • Novartis Investigative Site
  • LU
    • Lido di Camaiore, LU, Italy, 55041
      • Novartis Investigative Site
  • MB
    • Monza, MB, Italy, 20900
      • Novartis Investigative Site
  • MI
    • Rozzano, MI, Italy, 20089
      • Novartis Investigative Site
  • NU
    • Nuoro, NU, Italy, 08100
      • Novartis Investigative Site
  • PA
    • Palermo, PA, Italy, 90127
      • Novartis Investigative Site
    • Palermo, PA, Italy, 90146
      • Novartis Investigative Site
  • PC
    • Piacenza, PC, Italy, 29100
      • Novartis Investigative Site
  • PD
    • Cittadella, PD, Italy, 35013
      • Novartis Investigative Site
  • PI
    • Pisa, PI, Italy, 56124
      • Novartis Investigative Site
  • PN
    • Pordenone, PN, Italy, 33170
      • Novartis Investigative Site
  • PV
    • Voghera, PV, Italy, 27058
      • Novartis Investigative Site
  • RM
    • Roma, RM, Italy, 00128
      • Novartis Investigative Site
    • Roma, RM, Italy, 00161
      • Novartis Investigative Site
    • Roma, RM, Italy, 00189
      • Novartis Investigative Site
    • Roma, RM, Italy, 00163
      • Novartis Investigative Site
  • RN
    • Riccione, RN, Italy, 47838
      • Novartis Investigative Site
  • SI
    • Siena, SI, Italy, 53100
      • Novartis Investigative Site
  • SO
    • Sondalo, SO, Italy, 23035
      • Novartis Investigative Site
  • SS
    • Sassari, SS, Italy, 07100
      • Novartis Investigative Site
  • TO
    • Orbassano, TO, Italy, 10043
      • Novartis Investigative Site
  • TR
    • Terni, TR, Italy, 05100
      • Novartis Investigative Site
  • TV
    • Montebelluna, TV, Italy, 31044
      • Novartis Investigative Site
    • Vittorio Veneto, TV, Italy, 31029
      • Novartis Investigative Site
  • VA
    • Busto Arsizio, VA, Italy, 21052
      • Novartis Investigative Site
  • VI
    • Arzignano, VI, Italy, 36071
      • Novartis Investigative Site
    • Vicenza, VI, Italy, 36100
      • Novartis Investigative Site
  • VR
    • Bussolengo, VR, Italy, 37012
      • Novartis Investigative Site
• Latvia
  • Daugavpils, Latvia, LV-5401
    • Novartis Investigative Site
  • Riga, Latvia, LV 1002
    • Novartis Investigative Site
  • Riga, Latvia, LV-1001
    • Novartis Investigative Site
  • LV
    • Riga, LV, Latvia, LV-1038
      • Novartis Investigative Site
    • Riga, LV, Latvia, 1011
      • Novartis Investigative Site
  • LVA
    • Balvi, LVA, Latvia, 4501
      • Novartis Investigative Site
    • Jurmala, LVA, Latvia, LV-2015
      • Novartis Investigative Site
• Lithuania
  • Alytus, Lithuania, LT-62114
    • Novartis Investigative Site
  • Kaunas, Lithuania, 3007
    • Novartis Investigative Site
  • Klaipeda, Lithuania, LT-92288
    • Novartis Investigative Site
  • Utena, Lithuania, LT-28151
    • Novartis Investigative Site
  • Vilnius, Lithuania, LT-08661
    • Novartis Investigative Site
  • Vilnius, Lithuania, 06122
    • Novartis Investigative Site
  • LT
    • Kaunas, LT, Lithuania, LT-50128
      • Novartis Investigative Site
    • Vilnius, LT, Lithuania, 01117
      • Novartis Investigative Site
  • LTU
    • Vilnius, LTU, Lithuania, LT-10207
      • Novartis Investigative Site
• Norway
  • Førde, Norway, 6800
    • Novartis Investigative Site
  • Kløfta, Norway, 2040
    • Novartis Investigative Site
  • Lierskogen, Norway, 3420
    • Novartis Investigative Site
  • Oslo, Norway, 0190
    • Novartis Investigative Site
  • Oslo, Norway, 0953
    • Novartis Investigative Site
  • Skedsmokorset, Norway, 2020
    • Novartis Investigative Site
  • Skien, Norway, 3734
    • Novartis Investigative Site
  • Stavanger, Norway, 4005
    • Novartis Investigative Site
  • Tananger, Norway, 4056
    • Novartis Investigative Site
• Poland
  • Bialystok, Poland, 15-044
    • Novartis Investigative Site
  • Krakow, Poland, 31-024
    • Novartis Investigative Site
  • Nowy Dwor Mazowiecki, Poland, 05-100
    • Novartis Investigative Site
  • Ostrow Wielkopolski, Poland, 63-400
    • Novartis Investigative Site
  • Pila, Poland, 64-920
    • Novartis Investigative Site
  • Sopot, Poland, 81-741
    • Novartis Investigative Site
  • Warszawa, Poland, 01-138
    • Novartis Investigative Site
  • Wroclaw, Poland, 51-162
    • Novartis Investigative Site
• Portugal
  • Aveiro, Portugal, 3814-501
    • Novartis Investigative Site
  • Barcelos, Portugal, 4754-909
    • Novartis Investigative Site
  • Coimbra, Portugal, 3041-853
    • Novartis Investigative Site
  • Guimarães, Portugal, 4835-044
    • Novartis Investigative Site
  • Lisboa, Portugal, 1169-024
    • Novartis Investigative Site
  • Lisboa, Portugal, 1349-019
    • Novartis Investigative Site
  • Porto, Portugal, 4200 319
    • Novartis Investigative Site
  • Vila Franca de Xira, Portugal, 2600-009
    • Novartis Investigative Site
  • Vila Nova de Gaia, Portugal, 440-230
    • Novartis Investigative Site
• Romania
  • Bacau, Romania, 600252
    • Novartis Investigative Site
  • Bragadiru, Romania, 077025
    • Novartis Investigative Site
  • Constanta, Romania, 900591
    • Novartis Investigative Site
  • Ramnicu Valcea, Romania, 240564
    • Novartis Investigative Site
  • Suceava, Romania, 720284
    • Novartis Investigative Site
  • Timisoara, Romania, 300736
    • Novartis Investigative Site
  • District 3
    • Bucharest, District 3, Romania, 030303
      • Novartis Investigative Site
  • Jud. Iasi
    • Iasi, Jud. Iasi, Romania, 700115
      • Novartis Investigative Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454021
    • Novartis Investigative Site
  • Kazan, Russian Federation, 420012
    • Novartis Investigative Site
  • Kemerovo, Russian Federation, 650029
    • Novartis Investigative Site
  • Moscow, Russian Federation, 125315
    • Novartis Investigative Site
  • Moscow, Russian Federation, 101990
    • Novartis Investigative Site
  • N.Novgorod, Russian Federation, 603126
    • Novartis Investigative Site
  • Novosibirsk, Russian Federation, 630099
    • Novartis Investigative Site
  • Ryazan, Russian Federation, 390026
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 197022
    • Novartis Investigative Site
  • Saratov, Russian Federation, 410012
    • Novartis Investigative Site
  • Smolensk, Russian Federation, 214019
    • Novartis Investigative Site
  • St. Petersburg, Russian Federation, 194354
    • Novartis Investigative Site
  • Tomsk, Russian Federation, 634050
    • Novartis Investigative Site
  • Ufa, Russian Federation, 450000
    • Novartis Investigative Site
  • Yaroslavl, Russian Federation, 150003
    • Novartis Investigative Site
• Slovakia
  • Kralovsky Chlmec, Slovakia, 077 01
    • Novartis Investigative Site
  • Levice, Slovakia, 034 01
    • Novartis Investigative Site
  • Poprad, Slovakia, 058 01
    • Novartis Investigative Site
  • Presov, Slovakia, 080 01
    • Novartis Investigative Site
  • Presov, Slovakia, 08001
    • Novartis Investigative Site
  • Sala, Slovakia, 927 01
    • Novartis Investigative Site
  • Sturovo, Slovakia, 943 11
    • Novartis Investigative Site
  • Trnava, Slovakia, 917 75
    • Novartis Investigative Site
  • Vrable, Slovakia, 95201
    • Novartis Investigative Site
  • Slovak Republic
    • Bardejov, Slovak Republic, Slovakia, 085 01
      • Novartis Investigative Site
    • Bojnice, Slovak Republic, Slovakia, 972 01
      • Novartis Investigative Site
    • Liptovsky Hradok, Slovak Republic, Slovakia, 033 01
      • Novartis Investigative Site
  • Slovensko
    • Námestovo, Slovensko, Slovakia, 02901
      • Novartis Investigative Site
• Slovenia
  • Golnik, Slovenia, 4204
    • Novartis Investigative Site
  • Kranj, Slovenia, 4000
    • Novartis Investigative Site
  • Maribor, Slovenia, 2000
    • Novartis Investigative Site
  • Murska Sobota, Slovenia, 9000
    • Novartis Investigative Site
• Spain
  • Madrid, Spain, 28041
    • Novartis Investigative Site
  • Madrid, Spain, 28034
    • Novartis Investigative Site
  • Madrid, Spain, 28040
    • Novartis Investigative Site
  • Santiago de Compostela, Spain, 15706
    • Novartis Investigative Site
  • Zaragoza, Spain, 50009
    • Novartis Investigative Site
  • Andalucia
    • Cordoba, Andalucia, Spain, 14004
      • Novartis Investigative Site
    • Marbella, Andalucia, Spain, 29603
      • Novartis Investigative Site
    • Marbella, Andalucia, Spain, 29600
      • Novartis Investigative Site
    • Málaga, Andalucia, Spain, 29010
      • Novartis Investigative Site
  • Barcelona
    • Badalona, Barcelona, Spain, 08917
      • Novartis Investigative Site
    • Centelles, Barcelona, Spain, 08540
      • Novartis Investigative Site
    • Mataro, Barcelona, Spain, 08303
      • Novartis Investigative Site
    • Sabadell, Barcelona, Spain, 08208
      • Novartis Investigative Site
    • Sant Joan Despi, Barcelona, Spain, 08970
      • Novartis Investigative Site
    • Vic, Barcelona, Spain, 08500
      • Novartis Investigative Site
  • Castilla Y Leon
    • Ponferrada, Castilla Y Leon, Spain, 24400
      • Novartis Investigative Site
    • Salamanca, Castilla Y Leon, Spain, 37007
      • Novartis Investigative Site
  • Cataluna
    • Barcelona, Cataluna, Spain, 08036
      • Novartis Investigative Site
    • Canet de Mar, Cataluna, Spain, 08360
      • Novartis Investigative Site
    • Sant Boi de Llobregat, Cataluna, Spain, 08830
      • Novartis Investigative Site
  • Catalunya
    • Badalona, Catalunya, Spain, 08916
      • Novartis Investigative Site
  • Cataluña
    • Barcelona, Cataluña, Spain, 08035
      • Novartis Investigative Site
    • Vic, Cataluña, Spain, 08500
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Alzira, Comunidad Valenciana, Spain, 46600
      • Novartis Investigative Site
    • Benidorm, Comunidad Valenciana, Spain, 03501
      • Novartis Investigative Site
    • Puerto De Sagunto, Comunidad Valenciana, Spain, 46520
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46014
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46015
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46017
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46019
      • Novartis Investigative Site
  • Extremadura
    • Caceres, Extremadura, Spain, 10003
      • Novartis Investigative Site
    • Merida, Extremadura, Spain, 06800
      • Novartis Investigative Site
  • Granada
    • Motril, Granada, Spain, 18600
      • Novartis Investigative Site
  • Islas Baleares
    • Mallorca, Islas Baleares, Spain, 07198
      • Novartis Investigative Site
    • Palma de Mallorca, Islas Baleares, Spain, 07014
      • Novartis Investigative Site
  • Madrid
    • Valdemoro, Madrid, Spain, 28342
      • Novartis Investigative Site
  • Madrid, Communidad De
    • Madrid, Madrid, Communidad De, Spain, 28022
      • Novartis Investigative Site
    • Mostoles, Madrid, Communidad De, Spain, 28933
      • Novartis Investigative Site
• Sweden
  • Goteborg, Sweden, 413 46
    • Novartis Investigative Site
  • Gustavsberg, Sweden, 134 44
    • Novartis Investigative Site
  • Helsingborg, Sweden, 252 25
    • Novartis Investigative Site
  • Hollviken, Sweden, 236 32
    • Novartis Investigative Site
  • Kungshamn, Sweden, 456 31
    • Novartis Investigative Site
  • Limhamn, Sweden, 216 43
    • Novartis Investigative Site
  • Lund, Sweden, 222 22
    • Novartis Investigative Site
  • Råå, Sweden, 252 70
    • Novartis Investigative Site
  • Umea, Sweden, 907 40
    • Novartis Investigative Site
  • Vastra Frolunda, Sweden, 421 44
    • Novartis Investigative Site
  • Ostergotlands Lan
    • Linkoping, Ostergotlands Lan, Sweden, 587 58
      • Novartis Investigative Site
• United Kingdom
  • Bexhill-on-Sea, United Kingdom, TN40 1JJ
    • Novartis Investigative Site
  • Bristol, United Kingdom, BS10 6SP
    • Novartis Investigative Site
  • Bristol, United Kingdom, BS48 1BZ
    • Novartis Investigative Site
  • Cardiff, United Kingdom, CF5 4AD
    • Novartis Investigative Site
  • Chadderton, United Kingdom, OL9 0LH
    • Novartis Investigative Site
  • Cheshire, United Kingdom, CW1 4QJ
    • Novartis Investigative Site
  • Chesterfield, United Kingdom, S40 4AA
    • Novartis Investigative Site
  • Chippenham, United Kingdom, SN14 6GT
    • Novartis Investigative Site
  • Coventry, United Kingdom, CV6 4DD
    • Novartis Investigative Site
  • Hamilton, United Kingdom, ML3 8AA
    • Novartis Investigative Site
  • Lancashire, United Kingdom, FY3 7EN
    • Novartis Investigative Site
  • Manchester, United Kingdom, M8 9JT
    • Novartis Investigative Site
  • Motherwell, United Kingdom, ML1 3JX
    • Novartis Investigative Site
  • Oldham, United Kingdom, OL9 8NH
    • Novartis Investigative Site
  • Plymouth, United Kingdom, PL5 3JB
    • Novartis Investigative Site
  • Shrewsbury, United Kingdom, SY38XQ
    • Novartis Investigative Site
  • South Yorkshire, United Kingdom, DN9 1EP
    • Novartis Investigative Site
  • Stockton on Tees, United Kingdom, TS19 8PE
    • Novartis Investigative Site
  • Vale Of Glanmorgan, United Kingdom, CF63 4AR
    • Novartis Investigative Site
  • Watford, United Kingdom, WD25 7NL
    • Novartis Investigative Site
  • Wiltshire, United Kingdom, SN15 2SB
    • Novartis Investigative Site
  • Wishaw, United Kingdom, ML2 0DP
    • Novartis Investigative Site
  • Bucks
    • Aylesbury, Bucks, United Kingdom, HP22 5LB
      • Novartis Investigative Site
  • Cornwall
    • Fowey, Cornwall, United Kingdom, PL23 1DT
      • Novartis Investigative Site
    • Liskeard, Cornwall, United Kingdom, PL14 3XA
      • Novartis Investigative Site
    • Penzance, Cornwall, United Kingdom, TR18 AJH
      • Novartis Investigative Site
    • Redruth, Cornwall, United Kingdom
      • Novartis Investigative Site
    • St Austell, Cornwall, United Kingdom, PL26 7RL
      • Novartis Investigative Site
    • Torpoint, Cornwall, United Kingdom, PL11 2TB
      • Novartis Investigative Site
  • England
    • Bath, England, United Kingdom, BA2 3HT
      • Novartis Investigative Site
  • Hampshire
    • Havant, Hampshire, United Kingdom, PO9 1DQ
      • Novartis Investigative Site
  • Leicester
    • Burbage, Leicester, United Kingdom, LE10 2SE
      • Novartis Investigative Site
  • Northamptonshire
    • Daventry, Northamptonshire, United Kingdom, NN11 4DY
      • Novartis Investigative Site
  • Nottingham
    • Sneinton, Nottingham, United Kingdom, NG3 7DQ
      • Novartis Investigative Site
  • Somerset
    • Axbridge, Somerset, United Kingdom, BS26 2BJ
      • Novartis Investigative Site
    • Frome, Somerset, United Kingdom, BA11 2FH
      • Novartis Investigative Site
    • Taunton, Somerset, United Kingdom, TA1 5DA
      • Novartis Investigative Site
  • Tyne And Wear
    • South Shields, Tyne And Wear, United Kingdom, NE34 0PL
      • Novartis Investigative Site
  • Vale Of Glamorgan
    • Barry, Vale Of Glamorgan, United Kingdom, CF63 1BA
      • Novartis Investigative Site
  • Warwickshire
    • Leamington Spa, Warwickshire, United Kingdom, CV32 4RA
      • Novartis Investigative Site
  • West Sussex
    • Crawley, West Sussex, United Kingdom, RH10 7DX
      • Novartis Investigative Site
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
      • Novartis Investigative Site
  • Wiltshire
    • Trowbridge, Wiltshire, United Kingdom, BA14 8QA
      • Novartis Investigative Site
  • Yorkshire
    • Strensall, Yorkshire, United Kingdom, YO32 5UA
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 91 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female adults aged ≥ 40 years
• Patients with moderate COPD according to the GOLD criteria 2013
• Current or ex-smokers who have a smoking history of at least 10 pack years
• Patients with airflow limitation indicated by a postbronchodilator FEV1 ≥50% and <80% of the predicted normal value and a post-bronchodilator FEV1/FVC <0.7 at Visit 2. Post- bronchodilator refers to within 10-15 min of inhalation of 400 μg (4x100 μg) of salbutamol
• Patients who, at Visit 1, have been for at least 3 months on a stable dose of one of the following COPD baseline treatments: *Any SABA monotherapy (such as, but not limited to, salbutamol) *Any SAMA monotherapy (such as, but not limited to, ipratropium) *Any SABA and SAMA in free or FDC (such as, but not limited to, salbutamol/ipratropium) *Any LABA monotherapy (such as, but not limited to, formoterol, salmeterol, indacaterol) *Any LAMA monotherapy (such as, but not limited to, tiotropium, aclidinium) except glycopyrronium bromide (NVA237) *Any LABA and ICS in free (ICS such as, but not limited to, beclomethasone, fluticasone) or FDC (such as, but not limited to, salmeterol/fluticasone, formoterol/budesonide).
• Patients with an mMRC score ≥1 at Visit 1.

Exclusion Criteria:

• Patients with conditions contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs or to drugs of similar chemical classes or any component thereof: Anti-cholinergic agents, Long- and short-acting 2-adrenergic agonists, Sympathomimetic amines, Lactose or any of the other excipients of the trial medication.
• Patients with narrow-angle glaucoma or urinary retention, severe renal impairment (history of estimated glomerular filtration rate below 30 ml/min/1.73 m2 within 12 months prior to visit 1), including those with end-stage renal disease requiring dialysis.
• Patients with active/ clinical history of asthma.If the Investigator finds clear and compelling evidence that a patient was misdiagnosed with asthma in the past, then the burden of proof is on the Investigator to properly document this previous misdiagnosis. This documentation must include the rationale for this change in diagnosis including reference to the differential diagnosis that supports this decision.
• Patients with a history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• Patients who have a post-bronchodilator FEV1 decrease more than 10% compared to pre-bronchodilator FEV1 result at Visit 2 (see Appendix 5 for details).
• A documented history of >1 COPD exacerbation requiring treatment with systemic corticosteroids or antibiotics and/or hospitalization in the previous 12 months.
• Patients who have NOT had a COPD exacerbation in the previous 12 months and develop a COPD exacerbation between screening (Visit 1) and (Visit 2) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation. (Patients suffering an exacerbation between Visit 1 and Visit 2 can only be re-screened in case it is the first one in the previous 12 months. In case this COPD exacerbation has led to an alteration of the patient COPD treatment, before this patient can be re-screened 3 months of stable COPD treatment will be required as described in Inclusion Criterion 6).
• Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to): *Unstable ischemic heart disease, left ventricular failure (NYHA Class III & IV), history of myocardial infarction,arrhythmia (excluding chronic stable atrial fibrillation). Patients with such events not considered clinically significant by the investigator may be considered for inclusion in the study.*Uncontrolled hypo-or hyperthyroidism, hypokalaemia or hyperadrenergic state. *Any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
• History of resting QTc (Fridericia preferred, but Bazett acceptable) >450 msec (male) or >460 msec (female) within five years before Visit 1.
• Patients who are treated with glycopyrronium bromide (NVA237) at visit 1 are not allowed to be included into the trialPatients on non-selective beta-blockers. Those patients may enter the study after non-selective beta-blocker withdrawal during a 7-day wash-out period.
• Patients receiving any other prohibited COPD-related medications specified in Table 5-2 Prohibited COPD related medications must undergo the required wash-out period prior to Visit 2.
• Patients who are, in the opinion of the investigator known to be unreliable or non-compliant.
• Patients with a body mass index (BMI) of more than 40 kg/m2.
• Use of other investigational drugs within 5 half-lives of enrollment or within 30 days, whichever is longer.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A1 (any SABA and/or SAMA); Patients treated with any SABA and/or SAMA as monotherapy or in free or fixed dose combination will be assigned to glycopyrronium or will remain in their baseline therapy (3:1) during 90 days of treatment	Drug: Glycopyrronium; Glycopyrronium 50 µg capsule for inhalation via SDDPI once per day; Other Names: glycopyrronium bromide; Drug: SABA; Short-acting β2-adrenergic agonist (SABA) as per approved by each country and as prescribed for each patient, used as background therapy; Drug: SAMA; Short-acting muscarinic antagonist (SAMA) as per approved by each country and as prescribed for each patient, used as background therapy
Experimental: A2 (glycopyrronium); Patients treated with any SABA and/or SAMA as monotherapy or in free or FDC at enrollment and randomized to switch in treatment with glycopyrronium (50 μg o.d.)	Drug: Glycopyrronium; Glycopyrronium 50 µg capsule for inhalation via SDDPI once per day; Other Names: glycopyrronium bromide; Drug: SABA; Short-acting β2-adrenergic agonist (SABA) as per approved by each country and as prescribed for each patient, used as background therapy; Drug: SAMA; Short-acting muscarinic antagonist (SAMA) as per approved by each country and as prescribed for each patient, used as background therapy; Drug: LABA; Long Acting Beta Agonist (LABA) as per approved by each country and as prescribed for each patient, used as background therapy
Experimental: B1 (any LAMA or LABA and mMRC=1); Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to remain in their baseline treatment with LABA or LAMA	Drug: LABA; Long Acting Beta Agonist (LABA) as per approved by each country and as prescribed for each patient, used as background therapy; Drug: Indacaterol maleate and glycopyrronium bromide; Indacaterol maleate and glycopyrronium bromide fixed dose combination (110/50 µg) capsule for inhalation via SDDPI, once a day; Drug: LAMA; Long Acting Muscarinic Antagonist (LAMA) as per approved by each country and as prescribed for each patient, used as background therapy; Drug: ICS; Inhaled corticosteroid (ICS) as per approved by each country and as prescribed for each patient, used as background therapy
Experimental: B2 (glycopyrronium and mMRC=1); Patients treated with any LABA or LAMA monotherapy and mMRC score =1 point at Visit 1 and randomized to switch in treatment with glycopyrronium (50 μg o.d.)	Drug: LABA; Long Acting Beta Agonist (LABA) as per approved by each country and as prescribed for each patient, used as background therapy; Drug: Indacaterol maleate and glycopyrronium bromide; Indacaterol maleate and glycopyrronium bromide fixed dose combination (110/50 µg) capsule for inhalation via SDDPI, once a day; Drug: LAMA; Long Acting Muscarinic Antagonist (LAMA) as per approved by each country and as prescribed for each patient, used as background therapy
Experimental: C1 (any LABA and ICS); Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to remain in their baseline treatment with LABA and ICS in free or FDC	Drug: LABA; Long Acting Beta Agonist (LABA) as per approved by each country and as prescribed for each patient, used as background therapy; Drug: ICS; Inhaled corticosteroid (ICS) as per approved by each country and as prescribed for each patient, used as background therapy
Experimental: C2 (indacaterol/glycopyrronium); Patients treated with any LABA and ICS in free or FDC at enrollment and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.)	Drug: LABA; Long Acting Beta Agonist (LABA) as per approved by each country and as prescribed for each patient, used as background therapy; Drug: ICS; Inhaled corticosteroid (ICS) as per approved by each country and as prescribed for each patient, used as background therapy
Experimental: D1 (any LAMA or LABA and mMRC>1); Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to remain their baseline in treatment with LABA or LAMA	Drug: LAMA; Long Acting Muscarinic Antagonist (LAMA) as per approved by each country and as prescribed for each patient, used as background therapy
Experimental: D2 (indacaterol/glycopyrronium and mMRC>1); Patients treated with any LABA or LAMA monotherapy and mMRC score >1 point at Visit 1 and randomized to switch in treatment with indacaterol maleate and glycopyrronium bromide FDC (110/50 μg o.d.).	Drug: LAMA; Long Acting Muscarinic Antagonist (LAMA) as per approved by each country and as prescribed for each patient, used as background therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)	Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval	Week 12 (Visit 4)
Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)	Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval	Week 12 (Visit 4)
Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC	Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.	Week 12 (Visit 4)
Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)	Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.	Week 12 (Visit 4)
Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)	Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.	Day 1 (baseline) and week 12
Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)	Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.	Day 1 (baseline) and week 12
Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC	Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.	Day 1 (baseline) and week 12
Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)	Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.	Day 1 (baseline) and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)	Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval	12 Weeks
Change From Baseline on on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or Long-acting Bronchodilators (LABA or LAMA Monotherapy)	Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.	Day 1 (baseline) and week 12
Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC on Trough FEV1 at Week 12.	Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.	12 Weeks
Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC	Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.	Day 1 (baseline) and week 12
Change From Baseline on Total Score of COPD Assessment Test (CAT) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC	Total score of COPD Assessment Test (CAT) will be measured at baseline and at week 12. This questionnaire is completed by the patient. The score ranges from 0-40 where higher scores represent worse health status. CAT scores ≥ 10 are associated with significantly impaired health status.	Day 1 (baseline) and Week 12
Change From Baseline on Total Score of Clinical COPD Questionnaire (CCQ) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC	The Clinical COPD Questionnaire (CCQ) is a self-administered 10-item questionnaire developed to measure clinical control in patients with COPD. Patients will be instructed to recall their experiences during the previous week. They respond to each question using a 7-point scale from 0 = asymptomatic/no imitation to 6 = extremely symptomatic/totally limited. The questionnaire is divided into 3 domains (symptoms [items 1, 2, 5, and 6] functional [items 7, 8, 9, and 10] and mental state [items 3 and 4]). The overall clinical COPD control score and the scores of the domains are calculated by adding all the scores together and dividing this sum by the number of questions. Thus, the overall clinical COPD control score as well as the score on each of the three domains varies between 0 (very good control) to 6 (extremely poor control).	Day 1 (baseline) and Week 12
Mean Number of Puffs of Rescue Medication Use for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC	Mean number of puffs of rescue medication use will be measured using eDiary data over 12 weeks of treatment.	12 weeks
Mean Change From Baseline Reported Symptoms of COPD for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC	Patient-reported symptoms of COPD combined will be measured using eDiary data reported over the 12 week treatment period. The mean total symptom scores and mean individual symptom scores for the patient were calculated for the whole study period. The mean change from baseline in the total scores and in the individual scores were summarized by treatment and were analyzed for the percentage of nights with no nighttime awakenings and percentage of days with no symptoms.	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Greulich T, Kostikas K, Gaga M, Aalamian-Mattheis M, Lossi NS, Patalano F, Nunez X, Pagano VA, Fogel R, Vogelmeier CF, Clemens A. Indacaterol/glycopyrronium reduces the risk of clinically important deterioration after direct switch from baseline therapies in patients with moderate COPD: a post hoc analysis of the CRYSTAL study. Int J Chron Obstruct Pulmon Dis. 2018 Apr 16;13:1229-1237. doi: 10.2147/COPD.S159732. eCollection 2018.
• Vogelmeier CF, Gaga M, Aalamian-Mattheis M, Greulich T, Marin JM, Castellani W, Ninane V, Lane S, Nunez X, Patalano F, Clemens A, Kostikas K; CRYSTAL study investigators. Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial. Respir Res. 2017 Jul 18;18(1):140. doi: 10.1186/s12931-017-0622-x.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2014
• Primary Completion (Actual): April 29, 2016
• Study Completion (Actual): April 29, 2016

Study Registration Dates

• First Submitted: November 4, 2013
• First Submitted That Met QC Criteria: November 8, 2013
• First Posted (Estimate): November 15, 2013

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Moderate COPD, glycopyrronium bromide, indacaterol maleate and glycopyrronium bromide FDC, NVA237, QVA149
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Anticonvulsants; Glycopyrrolate; Bromides
• Other Study ID Numbers: CQVA149A3401