Clinical trial NCT01462929: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
antimuscarinic
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-11-01
Enrollment: 414
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Week 6
Secondary outcomes:
measure: Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment
timeFrame: Week 6
Other outcomes:
Locations:
city: Humpolec
country: Czech Republic
facility: Almirall Investigational Site #9
city: Jaromer
country: Czech Republic
facility: Almirall Investigational Site #1
city: Melnik
country: Czech Republic
facility: Almirall Investigational Site #3
city: Berlin
country: Germany
facility: Almirall Investigational Site #4
city: Berlin
country: Germany
facility: Almirall Investigational Site #12
city: Berlin
country: Germany
facility: Almirall Investigational Site #10
city: Berlin
country: Germany
facility: Almirall Investigational Site #8
city: Berlin
country: Germany
facility: Almirall Investigational Site #20
city: Berlin
country: Germany
facility: Almirall Investigational Site #21
city: Berlin
country: Germany
facility: Almirall Investigational Site #2
city: Dresden
country: Germany
facility: Almirall Investigational Site #13
city: Frankfurt
country: Germany
facility: Almirall Investigational Site #9
city: Grosshansdorf
country: Germany
facility: Almirall Investigational Site #3
city: Hamburg
country: Germany
facility: Almirall Investigational Site #1
city: Hamburg
country: Germany
facility: Almirall Investigational Site #18
city: Hannover
country: Germany
facility: Almirall Investigational Site #5
city: Hannover
country: Germany
facility: Almirall Investigational Site #22
city: Jena
country: Germany
facility: Almirall Investigational Site #14
city: Koln
country: Germany
facility: Almirall Investigational Site #24
city: Lubeck
country: Germany
facility: Almirall Investigational Site #17
city: Rudersdorf
country: Germany
facility: Almirall Investigational Site #23
city: Schwerin
country: Germany
facility: Almirall Investigational Site #6
city: Wiesbaden
country: Germany
facility: Almirall Investigational Site #16
city: Debrecen
country: Hungary
facility: Almirall Investigational Site #4
city: Komarom
country: Hungary
facility: Almirall Investigational Site #2
city: Matrahaza
country: Hungary
facility: Almirall Investigational Site #3
city: Szarvas
country: Hungary
facility: Almirall Investigational Site #1
city: Szigetszentmiklos
country: Hungary
facility: Almirall Investigational Site #11
city: Bialystok
country: Poland
facility: Almirall Investigational Site #18
city: Bialystok
country: Poland
facility: Almirall Investigational Site #8
city: Elblag
country: Poland
facility: Almirall Investigational Site #2
city: Krakow
country: Poland
facility: Almirall Investigational Site #17
city: Krakow
country: Poland
facility: Almirall Investigational Site #10
city: Lodz
country: Poland
facility: Almirall Investigational Site #16
city: Lodz
country: Poland
facility: Almirall Investigational Site #20
city: Proszowice
country: Poland
facility: Almirall Investigational Site #4
city: Sopot
country: Poland
facility: Almirall Investigational Site #6
city: Tarnow
country: Poland
facility: Almirall Investigational Site #14
city: Warszawa
country: Poland
facility: Almirall Investigational Site #19
city: Wilkowice-Bystra
country: Poland
facility: Almirall Investigational Site #12
city: Wroclaw
country: Poland
facility: Almirall Investigational Site #13
Study officials:
affiliation: AstraZeneca
name: Esther Garcia, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.