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)

NCT01471171 | Completed Phase 3 Results

• 1 other identifier: M/34273/40
• Study Type: interventional
• Target: 112
• Locations: 3 countries
• Sites: 14

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Antimuscarinic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)

  Week 3

• Change From Baseline in Intensity of Dyspnoea

  Week 3

Study Arms (2)

Aclidinium bromide

EXPERIMENTAL

3-week treatment periods

Drug: Aclidinium Bromide

Placebo

EXPERIMENTAL

3-week treatment periods

Drug: Placebo

Interventions

Aclidinium Bromide DRUG

1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)

Aclidinium bromide

Placebo DRUG

1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (14)

Almirall Investigational Site #10

Berlin, 10117, Germany

Location

Almirall Investigational Site #6

Berlin, 10117, Germany

Location

Almirall Investigational Site #2

Berlin, 14050, Germany

Location

Almirall Investigational Site #4

Frankfurt, 60596, Germany

Location

Almirall Investigational Site #5

Großhansdorf, 22927, Germany

Location

Almirall Investigational Site #8

Hamburg, 20354, Germany

Location

Almirall Investigational Site #9

Hamburg, 22335, Germany

Location

Almirall Investigational Site #3

Hanover, 30625, Germany

Location

Almirall Investigational Site #7

Lübeck, 23552, Germany

Location

Almirall Investigational Site #1

Wiesbaden, 65187, Germany

Location

Almirall Investigational Site #1

Alicante, 03114, Spain

Location

Almirall Investigational Site #4

Barcelona, 08003, Spain

Location

Almirall Investigational Site #2

Madrid, 28007, Spain

Location

Almirall Investigational Site #2

London, W1G 8HU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25539654 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

aclidinium bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: AstraZeneca Clinical
• Organization: Study Information Center

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Esther Garcia, Ph.D.

  AstraZeneca

  STUDY DIRECTOR

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 15, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 4, 2017
• Results First Posted: July 30, 2013

Record last verified: 2016-10

Locations

ES (3); GB (1); DE (10)