Safety, Tolerability, and Clinical Activity of ASM-024 Administered to Patients With GOLD 2 or GOLD 3 Chronic Obstructive Pulmonary Disease (COPD)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is a Phase II, randomized, double-blind, placebo-controlled, two-way crossover study to evaluate the safety, tolerability, and clinical activity of a new, dry powder for inhalation formulation of ASM-024 administered twice daily for 14 days to patients with GOLD-2 or GOLD-3 COPD.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ASM-024 Dry Powder for Inhalation, b.i.d., 14 days |
Drug: ASM-024
ASM-024 b.i.d for 14 days
|
| Placebo Comparator: Placebo Dry Powder for Inhalation, b.i.d., 14 days |
Drug: Placebo
Placebo b.i.d. for 14 days
|
Outcome Measures
Primary Outcome Measures
- FEV₁ AUC (0 -6 h) [Day 14]
Secondary Outcome Measures
- Change from baseline in Residual Volume (RV) [Days 1, 2, 3, & 14]
- Peak change in FEV₁ [Days 1, 2, 3, & 14]
- Change from baseline in Inspiratory Capacity (IC) [Days 1, 2, 3, & 14]
- Change from baseline in Functional Residual Capacity (FRC) [Days 1, 2, 3, &14]
- Change from baseline in FEV₁ [Day 14]
- Change from baseline in FEV₁/FVC [Days 1, 2, 3, & 14]
- FVC AUC (0-6 h) [Days 1, 2, 3, & 14]
- Use of rescue medication [From Day 1 to Day 14]
Other Outcome Measures
- 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]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut universitaire de cardiologie et de pneumologie de Québec | Quebec | Canada | G1V 4G5 |
Sponsors and Collaborators
- Asmacure Ltée
Investigators
- Study Chair: Yvon Cormier, M.D., Asmacure Ltée
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ASM-024/II/STA-04