Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)

The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Disease Disease Attributes Emphysema Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Forest Investigative Site 2201, Kelowna, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2010; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted
Current or former cigarette smokers

Exclusion criteria

Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
History or presence of asthma verified from medical records
Chronic use of oxygen therapy greater than or equal to 15 hours per day
Patient with uncontrolled infection due to HIV and/or active hepatitis
Patients with a history of hypersensitivity reaction to inhaled anticholinergics
Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.

Treatment and study plan

Aclidinium Bromide 200 µg

Drug

aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment

Aclidinium Bromide 400 µg

Drug

aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

Primary outcomes

Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)

Time frame: From baseline to 52 weeks

Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.

Secondary outcomes

Change From Baseline in Peak FEV1

Time frame: 52 weeks

Change From Baseline in Peak FEV1 in liters at Week 52.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease

Acronym: LAS-MD-35

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Jan 7, 2010
Registry last updated: Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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