COPD
Conditions
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.
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.
Interventions
DRUGASM-024
ASM-024 b.i.d for 14 days
DRUGPlacebo
Placebo b.i.d. for 14 days
Sponsors
Asmacure Ltée
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV₁ AUC (0 -6 h) | Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Use of rescue medication | From Day 1 to Day 14 |
Other
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed