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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asmacure Ltée

Criteria

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.