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)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471171
• Other study ID #: M/34273/40
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2011
• Last updated: May 28, 2015
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: May 2015
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Aclidinium Bromide
1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
• Placebo
1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)

Locations

Country	Name	City	State
Germany	Almirall Investigational Site #10	Berlin
Germany	Almirall Investigational Site #2	Berlin
Germany	Almirall Investigational Site #6	Berlin
Germany	Almirall Investigational Site #4	Frankfurt
Germany	Almirall Investigational Site #5	Grosshansdorf
Germany	Almirall Investigational Site #8	Hamburg
Germany	Almirall Investigational Site #9	Hamburg
Germany	Almirall Investigational Site #3	Hannover
Germany	Almirall Investigational Site #7	Lübeck
Germany	Almirall Investigational Site #1	Wiesbaden
Spain	Almirall Investigational Site #1	Alicante
Spain	Almirall Investigational Site #4	Barcelona
Spain	Almirall Investigational Site #2	Madrid
United Kingdom	Almirall Investigational Site #2	London

Sponsors (2)

Lead Sponsor	Collaborator
Almirall, S.A.	Forest Laboratories

Countries where clinical trial is conducted

Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Endurance Time (Seconds)	Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.	Week 3	No
Secondary	Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)	Change from baseline in trough IC after 3 weeks of treatment	Week 3	No
Secondary	Change From Baseline in Intensity of Dyspnoea	Change from baseline in intensity of dyspnoea based on the Borg CR10 Scale® (ranging from '0'=nothing at all to '10'=extremely strong/maximal dyspnoea, the highest possible numerical value) at isotime during constant work rate cycle ergometry after 3 weeks of treatment.	Week 3	No