Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)

The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.

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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

Completion of a lead-in study (NCT00891462)

Exclusion criteria

Use or anticipated use of any medication prohibited in this study
Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
QTcB of >500 msec on both the pre-dose and post-dose ECG
Women who are pregnant, intend to become pregnant, or are breast-feeding
A life expectancy of less than 1 year
Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.

Treatment and study plan

Aclidinium Bromide

Drug

Aclidinium bromide 200 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: Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks

Change From Baseline (Visit 2 of lead-in Study NCT00891462, [LAS-MD-33]) to Week 52 (Week 64 From Start of NCT00891462, [LAS-MD-33]) in Morning Predose (Trough) FEV1

Secondary outcomes

Change From Baseline in Peak FEV1

Time frame: 52 weeks

Change From Baseline (Visit 2 of study NCT00891462, [LAS-MD-33])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, [LAS-MD-33]).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Sep 2, 2009
Registry last updated: Jan 6, 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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