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

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)

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Drug: ASM-024; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Institut Universitaire De Cardiologie Et De Pneumologie De Québec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Asmacure Ltée
• Investigators: Study Chair: Yvon Cormier, M.D., Asmacure Ltée

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 10, 2013
• First Submitted That Met QC Criteria: May 13, 2013
• First Posted (Estimate): May 16, 2013

Study Record Updates

• Last Update Posted (Estimate): December 16, 2014
• Last Update Submitted That Met QC Criteria: December 15, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ASM-024/II/STA-04