Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Multiple Dose, Double-blind, Double-dummy, Placebo Controlled, Parallel Clinical Trial to Assess the Efficacy and Safety of Twice Daily Inhaled Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
414
4 countries
41
Brief Summary
The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2011
Shorter than P25 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2011
CompletedFirst Posted
Study publicly available on registry
November 1, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
May 22, 2013
CompletedJanuary 4, 2017
November 1, 2016
4 months
October 28, 2011
March 27, 2013
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment
Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.
Week 6
Secondary Outcomes (1)
Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment
Week 6
Study Arms (3)
Aclidinium bromide
EXPERIMENTALAclidinium bromide 400 µg administered twice per day during 6 weeks of treatment
Tiotropium
ACTIVE COMPARATORTiotropium bromide 18 µg administered once per day during 6 weeks of treatment
Placebo
PLACEBO COMPARATORPlacebo comparator administered during 6 weeks of treatment
Interventions
Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)
Dosage form: Dry powder Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (41)
Almirall Investigational Site #9
Humpolec, 396 26, Czechia
Almirall Investigational Site #1
Jaroměř, 551 01, Czechia
Almirall Investigational Site #3
Mělník, 276 01, Czechia
Almirall Investigational Site #4
Berlin, 10117, Germany
Almirall Investigational Site #12
Berlin, 10717, Germany
Almirall Investigational Site #10
Berlin, 10969, Germany
Almirall Investigational Site #8
Berlin, 13125, Germany
Almirall Investigational Site #20
Berlin, 13507, Germany
Almirall Investigational Site #21
Berlin, 14050, Germany
Almirall Investigational Site #2
Berlin, 14057, Germany
Almirall Investigational Site #24
Cologne, 51069, Germany
Almirall Investigational Site #13
Dresden, Germany
Almirall Investigational Site #9
Frankfurt, 60596, Germany
Almirall Investigational Site #3
Großhansdorf, 22927, Germany
Almirall Investigational Site #1
Hamburg, 20253, Germany
Almirall Investigational Site #18
Hamburg, 22143, Germany
Almirall Investigational Site #5
Hanover, 30159, Germany
Almirall Investigational Site #22
Hanover, 30625, Germany
Almirall Investigational Site #14
Jena, 07740, Germany
Almirall Investigational Site #17
Lübeck, 23552, Germany
Almirall Investigational Site #23
Rüdersdorf, 15562, Germany
Almirall Investigational Site #6
Schwerin, 19055, Germany
Almirall Investigational Site #16
Wiesbaden, 65187, Germany
Almirall Investigational Site #4
Debrecen, 4043, Hungary
Almirall Investigational Site #2
Komárom, 2900, Hungary
Almirall Investigational Site #3
Mátraháza, 3233, Hungary
Almirall Investigational Site #1
Szarvas, 5540, Hungary
Almirall Investigational Site #11
Szigetszentmiklós, 2310, Hungary
Almirall Investigational Site #18
Bialystok, 15-540, Poland
Almirall Investigational Site #8
Bialystok, 15-540, Poland
Almirall Investigational Site #2
Elblag, 82-300, Poland
Almirall Investigational Site #17
Krakow, 31-023, Poland
Almirall Investigational Site #10
Krakow, 31-455, Poland
Almirall Investigational Site #16
Lodz, 90-153, Poland
Almirall Investigational Site #20
Lodz, 90-153, Poland
Almirall Investigational Site #4
Proszowice, 32-100, Poland
Almirall Investigational Site #6
Sopot, 84-741, Poland
Almirall Investigational Site #14
Tarnów, 33-100, Poland
Almirall Investigational Site #19
Warsaw, 01-138, Poland
Almirall Investigational Site #12
Wilkowice-Bystra, 43-365, Poland
Almirall Investigational Site #13
Wroclaw, 50-349, Poland
Related Publications (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.
PMID: 28074135DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- AstraZeneca Clinical
- Organization
- Study Information Center
Study Officials
- STUDY DIRECTOR
Esther Garcia, Ph.D.
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2011
First Posted
November 1, 2011
Study Start
November 1, 2011
Primary Completion
March 1, 2012
Study Completion
May 1, 2012
Last Updated
January 4, 2017
Results First Posted
May 22, 2013
Record last verified: 2016-11