Clinical trial NCT01471171: Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Multiple Dose, Randomised, Double-blind, Placebo Controlled, 2 Period Crossover Clinical Trial to Assess the Effect of Aclidinium Bromide 400 μg BID on Exercise Endurance 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: 2011-11-15
Enrollment: 112
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Adult male and female patients aged ≥ 40 with stable moderate to severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines).
* Post-salbutamol Forced Expiratory Volume in one second(FEV1) \< 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) \< 70%.
* Current or ex-smokers of ≥ 10 pack-years
* Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value

Exclusion Criteria:

* History or current diagnosis of asthma
* Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period.
* Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
* Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
* Patients with an oxygen saturation \< 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit 1.
* Contra-indications of cardiopulmonary exercise testing.
* Patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the Screening Visit.

Primary outcomes:
measure: Change From Baseline in Endurance Time (Seconds)
timeFrame: Week 3
Secondary outcomes:
measure: Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)
timeFrame: Week 3
measure: Change From Baseline in Intensity of Dyspnoea
timeFrame: Week 3
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Almirall Investigational Site #10
city: Berlin
country: Germany
facility: Almirall Investigational Site #6
city: Berlin
country: Germany
facility: Almirall Investigational Site #2
city: Frankfurt
country: Germany
facility: Almirall Investigational Site #4
city: Grosshansdorf
country: Germany
facility: Almirall Investigational Site #5
city: Hamburg
country: Germany
facility: Almirall Investigational Site #8
city: Hamburg
country: Germany
facility: Almirall Investigational Site #9
city: Hannover
country: Germany
facility: Almirall Investigational Site #3
city: Lübeck
country: Germany
facility: Almirall Investigational Site #7
city: Wiesbaden
country: Germany
facility: Almirall Investigational Site #1
city: Alicante
country: Spain
facility: Almirall Investigational Site #1
city: Barcelona
country: Spain
facility: Almirall Investigational Site #4
city: Madrid
country: Spain
facility: Almirall Investigational Site #2
city: London
country: United Kingdom
facility: Almirall Investigational Site #2
Study officials:
affiliation: AstraZeneca
name: Esther Garcia, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Beeh KM, Watz H, Puente-Maestu L, de Teresa L, Jarreta D, Caracta C, Garcia Gil E, Magnussen H. Aclidinium improves exercise endurance, dyspnea, lung hyperinflation, and physical activity in patients with COPD: a randomized, placebo-controlled, crossover trial. BMC Pulm Med. 2014 Dec 23;14:209. doi: 10.1186/1471-2466-14-209.