Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Aclidinium bromide 200 μg bid; Drug: Aclidinium bromide 400 μg bid; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 828
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czech Republic
  • Benesov, Czech Republic, 256 01
    • Almirall Investigational Sites#4
  • Jaromer, Czech Republic, 55 101
    • Almirall Investigational Sites#9
  • Liberec, Czech Republic, 460 01
    • Almirall Investigational Sites#3
  • Lovosice, Czech Republic, 410 02
    • Almirall Investigational Sites#2
  • Neratovice, Czech Republic, 277 11
    • Almirall Investigational Sites#1
  • Praha, Czech Republic, 158 00
    • Almirall Investigational Sites#11
  • Praha, Czech Republic, 158 00
    • Almirall Investigational Sites#6
  • Praha, Czech Republic, 163 00
    • Almirall Investigational Sites#12
  • Praha, Czech Republic, 169 00
    • Almirall Investigational Sites#7
  • Strakonice, Czech Republic, 386 01
    • Almirall Investigational Sites#10
• France
  • Clermont-Ferrand Cedex, France, 63003
    • Almirall Investigational Sites#3
  • Marseille, France, 13008
    • Almirall Investigational Sites#2
  • Marseille Cedex 20, France, 13915
    • Almirall Investigational Sites#1
  • Montpellier, France, 34295
    • Almirall Investigational Sites#6
  • Toulouse Cedex, France, 31059
    • Almirall Investigational Sites#4
• Germany
  • Berlin, Germany, 10117
    • Almirall Investigational Sites#8
  • Berlin, Germany, 10969
    • Almirall Investigational Sites#9
  • Berlin, Germany, 13125
    • Almirall Investigational Sites#6
  • Berlin, Germany, 13507
    • Almirall Investigational Sites#14
  • Berlin, Germany, 14057
    • Almirall Investigational Site#7
  • Bonn, Germany, 53123
    • Almirall Investigational Sites#12
  • Dortmund, Germany, 44263
    • Almirall Investigational Sites#3
  • Frankfurt, Germany, 60596
    • Almirall Investigational Sites#13
  • Gelsenkirchen, Germany, 45879
    • Almirall Investigational Sites#15
  • Grosshansdorf, Germany, 22927
    • Almirall Investigational Sites#1
  • Hamburg, Germany, 20249
    • Almirall Investigational Sites#5
  • Hamburg, Germany, 22143
    • Almirall Investigational Sites#4
  • Hannover, Germany, 30159
    • Almirall Investigational Site#16
  • Jena, Germany, 07743
    • Almirall Investigational Sites#18
  • Koln, Germany, 51069
    • Almirall Investigational Sites#10
  • Mainz, Germany, 55131
    • Almirall Investigational Sites#11
  • Rüdersdorf, Germany, 15562
    • Almirall Investigational Site#2
• Hungary
  • Budapest, Hungary, 1036
    • Almirall Investigational Sites#13
  • Budapest, Hungary, 1046
    • Almirall Investigational Sites#4
  • Budapest, Hungary, 1125
    • Almirall Investigational Sites#1
  • Budapest, Hungary, 1529
    • Almirall Investigational Sites#2
  • Debrecen, Hungary, 4032
    • Almirall Investigational Sites#6
  • Debrecen, Hungary, 4043
    • Almirall Investigational Sites#5
  • Deszk, Hungary, 6772
    • Almirall Investigational Sites#7
  • Dunaüjváros, Hungary, 2400
    • Almirall Investigational Sites#10
  • Mátraháza, Hungary, 3233
    • Almirall Investigational Sites#9
  • Pécs, Hungary, 7621
    • Almirall Investigational Sites#12
  • Ráckeve, Hungary, 2300
    • Almirall Investigational Sites#11
  • Százhalombatta, Hungary, 2440
    • Almirall Investigational Sites#3
  • Zalaegerszeg, Hungary, 8900
    • Almirall Investigational Sites#8
• Italy
  • Cagliari, Italy, 09126
    • Almirall Investigational Sites#3
  • Genova, Italy, 16132
    • Almirall Investigational Sites#1
  • Pisa, Italy, 56124
    • Almirall Investigational Sites#10
• Peru
  • Cusco, Peru
    • Almirall Investigational Sites#8
• Poland
  • Białystok, Poland, 15-003
    • Almirall Investigational Sites#12
  • Białystok, Poland, 15-540
    • Almirall Investigational Sites#9
  • Elblag, Poland, 82-307
    • Almirall Investigational Sites#19
  • Gdansk, Poland, 80-211
    • Almirall Investigational Sites#18
  • Ilawa, Poland, 14-200
    • Almirall Investigational Sites#20
  • Lodz, Poland, 90-430
    • Almirall Investigational Sites#7
  • Lodz, Poland, 91-153
    • Almirall Investigational Sites#1
  • Lublin, Poland
    • Almirall Investigational Sites#8
  • Olsztyn, Poland, 10-357
    • Almirall Investigational Sites#24
  • Olsztyn, Poland, 10-357
    • Almirall Investigational Sites#5
  • Poznan, Poland, 60-214
    • Almirall Investigational Sites#21
  • Poznan, Poland, 60-693
    • Almirall Investigational Sites#16
  • Proszowice, Poland, 32-100
    • Almirall Investigational Site#11
  • Ruda Slaska, Poland, 41-709
    • Almirall Investigational Sites#2
  • Rudka, Poland, 05-320
    • Almirall Investigational Sites#13
  • Sopot, Poland, 81-741
    • Almirall Investigational Sites#4
  • Szczecin, Poland, 70-111
    • Almirall Investigational Sites#14
  • Tarnow, Poland, 33-100
    • Almirall Investigational Sites#6
  • Tarnów, Poland, 33-100
    • Almirall Investigational Sites#15
  • Warszawa, Poland, 01-138
    • Almirall Investigational Sites#25
  • Wilkowice-Bystra, Poland, 43-365
    • Almirall Investigational Sites#23
  • Wrocław, Poland, 50-349
    • Almirall Investigational Site#10
• Russian Federation
  • Ekaterinburg, Russian Federation, 620219 / 620109
    • Almirall Investigational Sites#7
  • Kazan, Russian Federation, 420015/420103
    • Almirall Investigational Sites#5
  • Moscow, Russian Federation, 115446
    • Almirall Investigational Sites#2
  • Moscow, Russian Federation, 123182
    • Almirall Investigational Sites#14
  • Moscow, Russian Federation, 127018/127473
    • Almirall Investigational Sites#6
  • Novosibirsk, Russian Federation, 630008
    • Almirall Investigational Sites#13
  • Saint-Petersburg, Russian Federation, 194354
    • Almirall Investigational Sites#10
  • Saint-Petersburg, Russian Federation, 197022
    • Almirall Investigational Sites#3
  • Saint-Petersburg, Russian Federation, 197089/197022
    • Almirall Investigational Sites#4
  • Tomsk, Russian Federation, 634050/634034
    • Almirall Investigational Sites#8
  • Tomsk, Russian Federation, 634050
    • Almirall Investigational Sites#12
• South Africa
  • Bloemfontein, South Africa, 9300
    • Almirall Investigational Sites#8
  • Bloemfontein, South Africa, 9301
    • Almirall Investigational Sites#11
  • Bloemfontein, South Africa, 9301
    • Almirall Investigational Sites#3
  • Cape Town, South Africa, 7500
    • Almirall Investigational Sites#10
  • Cape Town, South Africa, 7505
    • Almirall Investigational Sites#1
  • Cape Town, South Africa
    • Almirall Investigational Sites#12
  • Cape Town, South Africa
    • Almirall Investigational Sites#15
  • Durban, South Africa
    • Almirall Investigational Sites#2
  • George, South Africa, 6529
    • Almirall Investigational Sites#9
  • Port Elizabeth, South Africa, 6045
    • Almirall Investigational Sites#4
  • Pretoria, South Africa, 0002
    • Almirall Investigational Sites#5
  • Pretoria, South Africa, 0081
    • Almirall Investigational Sites#14
  • Pretoria, South Africa, 181
    • Almirall Investigational Sites#6
• Spain
  • Badalona, Spain, 08916
    • Almirall Investigational Sites#6
  • Barcelona, Spain, 08035
    • Almirall Investigational Sites#8
  • Barcelona, Spain, 08036
    • Almirall Investigational Sites#7
  • Madrid, Spain, 28041
    • Almirall Investigational Sites#3
  • Valencia, Spain, 46015
    • Almirall Investigational Sites#5
• Ukraine
  • Donetsk, Ukraine, 83099
    • Almirall Investigational Sites#4
  • Kharkiv, Ukraine, 61001
    • Almirall Investigational Sites#3
  • Kyiv, Ukraine, 03680
    • Almirall Investigational Sites#1
  • Kyiv, Ukraine, 03680
    • Almirall Investigational Sites#2
  • Kyiv, Ukraine, 04050
    • Almirall Investigational Sites#7
  • Zaporizhzhya, Ukraine, 69118
    • Almirall Investigational Sites#5

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:

• Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
• Post-salbutamol (FEV1) < 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%.
• Current or ex-smokers of ≥10 pack-years.

Exclusion Criteria:

• Patients with no history or current diagnosis of asthma.
• No evidence of an exacerbation within 6 weeks prior to the screening visit.
• No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
• No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo twice-daily by inhalation for 24 weeks
Experimental: Aclidinium bromide 200 μg bid; Aclidinium bromide 200 μg twice-daily via inhalation	Drug: Aclidinium bromide 200 μg bid; Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks
Experimental: Aclidininum bromide 400 μg bid; Aclidinium bromide 400 μg twice-daily via inhalation	Drug: Aclidinium bromide 400 μg bid; Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment	Baseline and Week 24
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment		Baseline and Week 24
Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment	Number of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score at Week 24 on Treatment	Week 24
Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment	Number of patients who achieved a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score at week 24 on treatment	Week 24

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• Jones PW, Leidy NK, Hareendran A, Lamarca R, Chuecos F, Garcia Gil E. The effect of aclidinium bromide on daily respiratory symptoms of COPD, measured using the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) diary: pooled analysis of two 6-month Phase III studies. Respir Res. 2016 May 23;17(1):61. doi: 10.1186/s12931-016-0372-1.
• McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.
• Jones PW, Lamarca R, Chuecos F, Singh D, Agusti A, Bateman ED, de Miquel G, Caracta C, Garcia Gil E. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. 2014 Nov;44(5):1156-65. doi: 10.1183/09031936.00038814. Epub 2014 Sep 18.
• Jones PW, Singh D, Bateman ED, Agusti A, Lamarca R, de Miquel G, Segarra R, Caracta C, Garcia Gil E. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study. Eur Respir J. 2012 Oct;40(4):830-6. doi: 10.1183/09031936.00225511. Epub 2012 Mar 22.

Helpful Links

• Almirall Corporate Website

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: October 22, 2009
• First Submitted That Met QC Criteria: October 23, 2009
• First Posted (Estimate): October 26, 2009

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease; antimuscarinic
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anticonvulsants; Bromides
• Other Study ID Numbers: M/34273/34; ATTAIN