Safety, Tolerability, and Clinical Activity of ASM-024 Administered to Patients With GOLD 2 or GOLD 3 Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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COPD

Intervention / Treatment
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* Drug: ASM-024
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASM-024<br>Dry Powder for Inhalation, b.i.d., 14 days | Drug: ASM-024<br>* ASM-024 b.i.d for 14 days<br>|
| Placebo Comparator: Placebo<br>Dry Powder for Inhalation, b.i.d., 14 days | Drug: Placebo<br>* Placebo b.i.d. for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV₁ AUC (0 -6 h) |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |