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

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.

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.