Evaluation of the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD

A 26-week, Randomized, Double Blind, Parallel-group Multicenter Study to Assess the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD

This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPD

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: QVA149; Drug: Tiotropium; Drug: Salmeterol/fluticasone

• Study Type: Interventional
• Enrollment (Actual): 1053
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina
    • Novartis Investigative Site
  • Ciudad Autonoma de Bs As, Argentina, C1425FVH
    • Novartis Investigative Site
  • Mendoza, Argentina, M5500CBA
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1425BEN
      • Novartis Investigative Site
    • Lanus, Buenos Aires, Argentina, B8000XAV
      • Novartis Investigative Site
    • Mar del Plata, Buenos Aires, Argentina, B7600FZN
      • Novartis Investigative Site
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Novartis Investigative Site
    • Quilmes, Buenos Aires, Argentina, B1878FNR
      • Novartis Investigative Site
  • Entre Rios
    • Concepcion del Uruguay, Entre Rios, Argentina, 3260
      • Novartis Investigative Site
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Novartis Investigative Site
    • San Miguel de Tucuman, Tucuman, Argentina, T4000IFL
      • Novartis Investigative Site
• Austria
  • Amstetten, Austria, 3300
    • Novartis Investigative Site
  • Feldbach, Austria, 8330
    • Novartis Investigative Site
  • Feldkirch, Austria, 6800
    • Novartis Investigative Site
  • Grieskirchen, Austria, 4710
    • Novartis Investigative Site
  • Thalheim bei Wels, Austria, 4600
    • Novartis Investigative Site
• Belgium
  • Antwerpen, Belgium, 2060
    • Novartis Investigative Site
  • Eghezee, Belgium, 5310
    • Novartis Investigative Site
  • Erpent, Belgium, 5100
    • Novartis Investigative Site
  • Hasselt, Belgium, 3500
    • Novartis Investigative Site
  • Turnhout, Belgium, 2300
    • Novartis Investigative Site
• Bulgaria
  • Gabrovo, Bulgaria, 5300
    • Novartis Investigative Site
  • Ruse, Bulgaria, 7000
    • Novartis Investigative Site
  • Stara Zagora, Bulgaria, 6000
    • Novartis Investigative Site
  • Varna, Bulgaria, 9000
    • Novartis Investigative Site
• Canada
  • Quebec, Canada, G1G 3Y8
    • Novartis Investigative Site
  • Quebec, Canada, G1W 4R4
    • Novartis Investigative Site
  • Quebec, Canada, G3K 2P8
    • Novartis Investigative Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Novartis Investigative Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • Novartis Investigative Site
  • Ontario
    • Burlington, Ontario, Canada, L7N 3V2
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M6H 3M2
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M5T 3A9
      • Novartis Investigative Site
  • Quebec
    • Gatineau, Quebec, Canada, J8Y 6S8
      • Novartis Investigative Site
    • St-Charles-Borromée, Quebec, Canada, J6E 2B4
      • Novartis Investigative Site
    • Victoriaville, Quebec, Canada, G6P 6P6
      • Novartis Investigative Site
• Croatia
  • Zagreb, Croatia, 10000
    • Novartis Investigative Site
  • HRV
    • Rijeka, HRV, Croatia, 51000
      • Novartis Investigative Site
• Czechia
  • Benesov, Czechia, 25601
    • Novartis Investigative Site
  • Brandys nad Labem, Czechia, 25001
    • Novartis Investigative Site
  • Kyjov, Czechia, 697 33
    • Novartis Investigative Site
  • Plzen, Czechia, 32800
    • Novartis Investigative Site
  • Czech Republic
    • Melnik, Czech Republic, Czechia, 267 01
      • Novartis Investigative Site
• Denmark
  • Copenhagen NV, Denmark, 2400
    • Novartis Investigative Site
  • Hvidovre, Denmark, 2650
    • Novartis Investigative Site
• Estonia
  • Kohtla-Jarve, Estonia, 30322
    • Novartis Investigative Site
  • Tallinn, Estonia, 13419
    • Novartis Investigative Site
  • Tallinn, Estonia, 10138
    • Novartis Investigative Site
  • Tartu, Estonia, 51014
    • Novartis Investigative Site
• Germany
  • Bad Woerishofen, Germany, 86825
    • Novartis Investigative Site
  • Berlin, Germany, 12203
    • Novartis Investigative Site
  • Berlin, Germany, 10717
    • Novartis Investigative Site
  • Berlin, Germany, 10117
    • Novartis Investigative Site
  • Berlin, Germany, 10367
    • Novartis Investigative Site
  • Berlin, Germany, 13156
    • Novartis Investigative Site
  • Berlin, Germany, 10787
    • Novartis Investigative Site
  • Berlin, Germany, 10969
    • Novartis Investigative Site
  • Berlin, Germany, 12157
    • Novartis Investigative Site
  • Berlin, Germany, 12159
    • Novartis Investigative Site
  • Berlin, Germany, 10119
    • Novartis Investigative Site
  • Berlin, Germany, 10625
    • Novartis Investigative Site
  • Bonn, Germany, 53123
    • Novartis Investigative Site
  • Dresden, Germany, 01069
    • Novartis Investigative Site
  • Erlangen, Germany, 91052
    • Novartis Investigative Site
  • Frankfurt, Germany, 60596
    • Novartis Investigative Site
  • Frankfurt am Main, Germany, 60389
    • Novartis Investigative Site
  • Hagen, Germany, 58089
    • Novartis Investigative Site
  • Hamburg, Germany, 20354
    • Novartis Investigative Site
  • Hamburg, Germany, 22143
    • Novartis Investigative Site
  • Leipzig, Germany, 04207
    • Novartis Investigative Site
  • Leipzig, Germany, 04357
    • Novartis Investigative Site
  • Leipzig, Germany, 04103
    • Novartis Investigative Site
  • Leipzig, Germany, 04109
    • Novartis Investigative Site
  • Lubeck, Germany, 23552
    • Novartis Investigative Site
  • Magdeburg, Germany, 39112
    • Novartis Investigative Site
  • Marburg, Germany, 35037
    • Novartis Investigative Site
  • Menden, Germany, 58706
    • Novartis Investigative Site
  • Neu Isenburg, Germany, 63263
    • Novartis Investigative Site
  • Oschatz, Germany, 04758
    • Novartis Investigative Site
  • Potsdam, Germany, 14467
    • Novartis Investigative Site
  • Potsdam, Germany, 14469
    • Novartis Investigative Site
  • Rudersdorf, Germany, 15562
    • Novartis Investigative Site
  • Schleswig, Germany, 24837
    • Novartis Investigative Site
  • Solingen, Germany, 42651
    • Novartis Investigative Site
  • Wiesloch, Germany, 69168
    • Novartis Investigative Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30159
      • Novartis Investigative Site
    • Peine, Niedersachsen, Germany, 31224
      • Novartis Investigative Site
  • Nordrhein-Westfalen
    • Warendorf, Nordrhein-Westfalen, Germany, 48231
      • Novartis Investigative Site
  • Rheinland-Pfalz
    • Koblenz, Rheinland-Pfalz, Germany, 56068
      • Novartis Investigative Site
  • Sachsen
    • Cottbus, Sachsen, Germany, 03050
      • Novartis Investigative Site
• Greece
  • Athens, Greece, 106 76
    • Novartis Investigative Site
  • Heraklion - Crete, Greece, 711 10
    • Novartis Investigative Site
  • GR
    • Thessaloniki, GR, Greece, 570 10
      • Novartis Investigative Site
• Hungary
  • Balassagyarmat, Hungary, 2660
    • Novartis Investigative Site
  • Budapest, Hungary, 1121
    • Novartis Investigative Site
  • Szekszard, Hungary, 7100
    • Novartis Investigative Site
  • HUN
    • Szazhalombatta, HUN, Hungary, 2440
      • Novartis Investigative Site
  • Pest
    • Torokbalint, Pest, Hungary, 2045
      • Novartis Investigative Site
• Latvia
  • Daugavpils, Latvia, LV-5401
    • Novartis Investigative Site
  • Kraslava, Latvia, 5601
    • Novartis Investigative Site
  • Riga, Latvia, LV 1002
    • Novartis Investigative Site
  • Riga, Latvia, LV-1038
    • Novartis Investigative Site
  • LV
    • Liepaja, LV, Latvia, LV-3414
      • 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
  • Klaipeda, Lithuania, LT-92231
    • 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
• Netherlands
  • Alkmaar, Netherlands, 1814HB
    • Novartis Investigative Site
  • Breda, Netherlands, 4819 EV
    • Novartis Investigative Site
  • Eindhoven, Netherlands, 5623 EJ
    • Novartis Investigative Site
  • Zutphen, Netherlands, 7207 AE
    • Novartis Investigative Site
• Poland
  • Bialystok, Poland, 15-044
    • Novartis Investigative Site
  • Bialystok, Poland, 15-351
    • Novartis Investigative Site
  • Bialystok, Poland, 15-270
    • Novartis Investigative Site
  • Bienkowka, Poland, 34-212
    • Novartis Investigative Site
  • Krakow, Poland, 31-023
    • Novartis Investigative Site
  • Lodz, Poland, 90-153
    • Novartis Investigative Site
  • Lublin, Poland, 20-045
    • Novartis Investigative Site
  • Ostrów Wielkopolski, Poland, 63400
    • Novartis Investigative Site
  • Poznan, Poland, 60-214
    • Novartis Investigative Site
  • Poznan, Poland, 60-823
    • Novartis Investigative Site
  • Sopot, Poland, 81-741
    • Novartis Investigative Site
  • Tarnow, Poland, 33-100
    • Novartis Investigative Site
  • Wroclaw, Poland, 50-434
    • Novartis Investigative Site
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 53-301
      • Novartis Investigative Site
  • Swietokrzyskie
    • Ostrowiec Swietokrzyskie, Swietokrzyskie, Poland, 27-400
      • Novartis Investigative Site
• Romania
  • Arad, Romania, 310013
    • Novartis Investigative Site
  • Arad, Romania, 310416
    • Novartis Investigative Site
  • Brasov, Romania, 500086
    • Novartis Investigative Site
  • Bucharest, Romania, 050159
    • Novartis Investigative Site
  • Bucharest, Romania, 303330
    • Novartis Investigative Site
  • Bucuresti, Romania, 012051
    • Novartis Investigative Site
  • Cluj Napoca, Romania, 400371
    • Novartis Investigative Site
  • Deva, Romania, 330162
    • Novartis Investigative Site
  • District 1
    • Bucuresti, District 1, Romania, 10457
      • Novartis Investigative Site
  • Timis
    • Timisoara, Timis, Romania, 300310
      • Novartis Investigative Site
• Serbia
  • Belgrade, Serbia, 11000
    • Novartis Investigative Site
  • Beograd, Serbia, 11000
    • Novartis Investigative Site
  • Knez Selo, Serbia, 18204
    • Novartis Investigative Site
  • Kragujevac, Serbia, 34000
    • Novartis Investigative Site
  • Valjevo, Serbia, 14000
    • Novartis Investigative Site
• Slovakia
  • Humenne, Slovakia, 06601
    • Novartis Investigative Site
  • Poprad, Slovakia, 058 01
    • Novartis Investigative Site
  • Presov, Slovakia, 080 01
    • Novartis Investigative Site
  • Spisska Nova Ves, Slovakia, 052 01
    • Novartis Investigative Site
• Spain
  • Andalucia
    • Malaga, Andalucia, Spain, 29010
      • Novartis Investigative Site
  • Barcelona
    • Centelles, Barcelona, Spain, 08540
      • Novartis Investigative Site
  • Castilla Y Leon
    • Ponferrada, Castilla Y Leon, Spain, 24400
      • Novartis Investigative Site
  • Cataluna
    • Canet de Mar, Cataluna, Spain, 08360
      • Novartis Investigative Site
  • Cataluña
    • L´Hospitalet de Llobregat, Cataluña, Spain, 08907
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Alzira, Comunidad Valenciana, Spain, 46600
      • Novartis Investigative Site
    • San Juan de Alicante, Comunidad Valenciana, Spain, 03550
      • Novartis Investigative Site
  • Extremadura
    • Merida, Extremadura, Spain, 06800
      • Novartis Investigative Site
• United Kingdom
  • Bath, United Kingdom, BA2 3HT
    • Novartis Investigative Site
  • Birmingham, United Kingdom, B9 5SS
    • Novartis Investigative Site
  • Birmingham, United Kingdom, B15 2TH
    • Novartis Investigative Site
  • Coventry, United Kingdom, CV2 2DX
    • Novartis Investigative Site
  • Plymouth, United Kingdom, PL5 3JB
    • Novartis Investigative Site
  • Wolverhampton, United Kingdom, WV10 0QP
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who have signed Informed Consent Form prior to initiation of any study-related procedure.
• Male and female adults aged ≥ 40 years.
• Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3) according to the 2014 GOLD Guidelines.
• Patients with a post-bronchodilator FEV1 ≥40 and < 80% of the predicted normal value, and post-bronchodilator FEV1/FVC < 0.70 at run-in Visit 101. (Post refers to 15 min after inhalation of 400 µg of salbutamol).
• Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at screening.
• Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS).

Exclusion Criteria:

• Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria) .
• Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1.
• Patients who developed a COPD exacerbation of any severity either 6 weeks before the screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) 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.

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QVA149	Drug: QVA149; QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI
Active Comparator: Tiotropium + salmeterol/fluticasone	Drug: Tiotropium; Tiotropium will be supplied as commercially available blisters, delivered via HandiHaler®; Drug: Salmeterol/fluticasone; Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Post-dose Trough FEV1	Mean change from baseline in post-dose trough forced expiratory volume in 1 second (FEV1) following 26 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values measured at 23 hr 15 min and 23 hr 45 min after the morning dose taken at site on Day 181. Baseline FEV1 is defined as the average of the pre-dose FEV1 measured at -45 min and -15 min at Day 1.	Baseline, 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Rate of Moderate or Severe COPD Exacerbations	Moderate or severe COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event.	26 weeks
Annualized Rate of COPD Exacerbations Requiring Treatment With Systemic Glucocorticosteroids and/or Antibiotics, Moderate Exacerbations Only	COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event	26 weeks
Annualized Rate of COPD Exacerbations Requiring Hospitalisation	COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event.	26 weeks
Mean Change From Baseline in Pre-dose Trough FEV1	Trough FEV1 is defined as the average of the pre-dose FEV1 measurements at -45 min and -15 min prior to dosing at each visit except Day 182 which is the average of the post-dose FEV1 measurements at 23h15min and 23h45min after dosing at Day 181. Baseline FEV1 is considered the Day 1 average of pre-dose measurements.	26 weeks
Mean Change From Baseline in St. George's Respiratory Questionnaire	The St. George Respiratory Questionnaire C (SGRQ-C) is used to provide the health status measurements in this study. Baseline SGRQ-C is defined as the assessment taken right before the first dose of the double-blind drug on Day 1. Higher values correspond to greater impairment of health status. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.	Baseline, 12 weeks
Mean Change From Baseline in St. George's Respiratory Questionnaire	The St. George Respiratory Questionnaire C (SGRQ-C) is used to provide the health status measurements in this study. Baseline SGRQ-C is defined as the assessment taken right before the first dose of the double-blind drug on Day 1. Higher values correspond to greater impairment of health status. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.	Baseline, 26 weeks
Transition Dyspnea Index (TDI) Score	Transitional Dyspnea Index (TDI) score presents the degree of impairment due to dyspnea. The lower the score the worse the severity of dyspnea. The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.	12 weeks
Transition Dyspnea Index (TDI) Score	Transitional Dyspnea Index (TDI) score presents the degree of impairment due to dyspnea. The lower the score the worse the severity of dyspnea. The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.	26 weeks
Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication	Change from baseline in mean daily number of puffs of rescue medication (number of puffs taken in the previous 12 hours) over 26 weeks of treatment.	Baseline, 26 weeks
Mean Change From Baseline in Forced Vital Capacity (FVC)	Change from baseline in forced vital capacity following 26 weeks of treatment. Trough FVC is defined as the average of the pre-dose FVC measurements at -45 min and -15 min prior to dosing at each visit except Day 182 which is the average of the post-dose FVC measurements at 23h15min and 23h45min after dosing at Day 181. Baseline is considered the Day 1 average of pre-dose measurements.	Baseline, 26 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Chapman KR, Hurst JR, Frent SM, Larbig M, Fogel R, Guerin T, Banerji D, Patalano F, Goyal P, Pfister P, Kostikas K, Wedzicha JA. Long-Term Triple Therapy De-escalation to Indacaterol/Glycopyrronium in Patients with Chronic Obstructive Pulmonary Disease (SUNSET): A Randomized, Double-Blind, Triple-Dummy Clinical Trial. Am J Respir Crit Care Med. 2018 Aug 1;198(3):329-339. doi: 10.1164/rccm.201803-0405OC.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2015
• Primary Completion (Actual): July 18, 2017
• Study Completion (Actual): July 18, 2017

Study Registration Dates

• First Submitted: September 17, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): April 29, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: COPD, QVA149
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Anti-Inflammatory Agents; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Fluticasone; Salmeterol Xinafoate; Tiotropium Bromide
• Other Study ID Numbers: CQVA149A2316; 2015-000114-22 (EudraCT Number)