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)

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Aclidinium Bromide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Almirall Investigational Site #10
  • Berlin, Germany, 10117
    • Almirall Investigational Site #6
  • Berlin, Germany, 14050
    • Almirall Investigational Site #2
  • Frankfurt, Germany, 60596
    • Almirall Investigational Site #4
  • Grosshansdorf, Germany, 22927
    • Almirall Investigational Site #5
  • Hamburg, Germany, 20354
    • Almirall Investigational Site #8
  • Hamburg, Germany, 22335
    • Almirall Investigational Site #9
  • Hannover, Germany, 30625
    • Almirall Investigational Site #3
  • Lübeck, Germany, 23552
    • Almirall Investigational Site #7
  • Wiesbaden, Germany, 65187
    • Almirall Investigational Site #1
• Spain
  • Alicante, Spain, 03114
    • Almirall Investigational Site #1
  • Barcelona, Spain, 08003
    • Almirall Investigational Site #4
  • Madrid, Spain, 28007
    • Almirall Investigational Site #2
• United Kingdom
  • London, United Kingdom, W1G 8HU
    • Almirall Investigational Site #2

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 (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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aclidinium bromide; 3-week treatment periods	Drug: Aclidinium Bromide; 1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
Experimental: Placebo; 3-week treatment periods	Drug: Placebo; 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)	Change from baseline in trough IC after 3 weeks of treatment	Week 3
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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 15, 2011

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; Antimuscarinic
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anticonvulsants; Bromides
• Other Study ID Numbers: M/34273/40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No