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

Phase 2

Completed

• Conditions: COPD
• Interventions: Drug: ASM-024; Drug: Placebo

• Registration Number: NCT01855230
• Lead Sponsor: Asmacure Ltée

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.

Study Timeline

• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-16
• Study Start: 2013-08
• Primary Completion: 2014-10
• Status Verified: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ASM-024	ASM-024	Dry Powder for Inhalation, b.i.d., 14 days
Placebo	Placebo	Dry Powder for Inhalation, b.i.d., 14 days

Primary Outcome Measures

Name	Time	Method
FEV₁ AUC (0 -6 h)	Day 14

Secondary Outcome Measures

Name	Time	Method
FVC AUC (0-6 h)	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
Use of rescue medication	From Day 1 to Day 14
Change from baseline in Residual Volume (RV)	Days 1, 2, 3, & 14
Change from baseline in Inspiratory Capacity (IC)	Days 1, 2, 3, & 14
Peak change in FEV₁	Days 1, 2, 3, & 14

Trial Locations

Locations (1)

Institut universitaire de cardiologie et de pneumologie de Québec; 🇨🇦 Quebec, Canada