Status:
COMPLETED
Safety, Tolerability, and Clinical Activity of ASM-024 Administered to Patients With GOLD 2 or GOLD 3 Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Asmacure Ltée
Conditions:
COPD
Eligibility:
All Genders
40+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01855230
Start Date
August 1 2013
End Date
December 1 2014
Last Update
December 16 2014
Active Locations (1)
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1
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5