COPD Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Two-Way Crossover Study to Evaluate the Safety, Tolerability and Clinical Activity of ASM-024 Administered by Dry Power Inhalation to Patients With GOLD 2 (Moderate) or GOLD 3 (Severe) Chronic Obstructive Pulmonary Disease (COPD)
Verified date | December 2014 |
Source | Asmacure Ltée |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
The purpose of this study is to evaluate the safety, tolerability, and clinical activity of ASM-024 administered as a dry powder for inhalation formulation to patients with GOLD 2 or GOLD 3 COPD.
Status | Completed |
Enrollment | 14 |
Est. completion date | December 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Male or female adult aged over 40 yrs with a clinically confirmed diagnosis of COPD at the severity stages of GOLD 2 (moderate) or 3 (severe); - Stable COPD for 1 month prior to screening - Stable smoker for at least three months prior to screening, or non-smoker, with a smoking history of = 10 packs years; - FEV1 = 30 % and < 70 % of the predicted normal value; - Normal 12-lead ECG Exclusion Criteria: - Clinically significant illness except COPD or surgery within 8 weeks prior to first administration of the study medication; - Significant medical history that, in the Investigator's opinion, may adversely affect participation; - History of allergy or significant adverse reaction to drugs similar to ASM-024, to nicotine, or to cholinergic drugs or any drugs with a similar chemical structure; - History of hypersensitivity (anaphylaxis, angioedema) to any drug; - Positive pregnancy test for female subjects; - Use of medications known to prolong QT/QTc interval; - Clinically significant 12 lead ECG at screening; - Clinically significant physical examination or laboratory findings or abnormal vital signs; - History of alcohol or drug abuse; - Positive hepatitis B or C or HIV test at Screening; - Investigational drug within 30 days of Screening; long-acting investigational drug within 90 days of screening; - Previous exposure to ASM-024; and - Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Institut universitaire de cardiologie et de pneumologie de Québec | Quebec |
Lead Sponsor | Collaborator |
---|---|
Asmacure Ltée |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety and Tolerability | Physical examination: Day 14; vital signs: Days 1, 2, 3, & 14; 12-lead ECG: Days 1, 2, 3, & 14; AEs: from Day 1 to patient's final study visit; clinical laboratory evaluations: Day 14 | Yes | |
Primary | FEV1 AUC (0 -6 h) | Day 14 | No | |
Secondary | Change from baseline in Residual Volume (RV) | Days 1, 2, 3, & 14 | No | |
Secondary | Peak change in FEV1 | Days 1, 2, 3, & 14 | No | |
Secondary | Change from baseline in Inspiratory Capacity (IC) | Days 1, 2, 3, & 14 | No | |
Secondary | Change from baseline in Functional Residual Capacity (FRC) | Days 1, 2, 3, &14 | No | |
Secondary | Change from baseline in FEV1 | Day 14 | No | |
Secondary | Change from baseline in FEV1/FVC | Days 1, 2, 3, & 14 | No | |
Secondary | FVC AUC (0-6 h) | Days 1, 2, 3, & 14 | No | |
Secondary | Use of rescue medication | From Day 1 to Day 14 | No |
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