Clinical trial NCT01855230: Safety, Tolerability, and Clinical Activity of ASM-024 Administered to Patients With GOLD 2 or GOLD 3 Chronic Obstructive Pulmonary Disease (COPD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD
Lead sponsor: Asmacure Ltée
Sponsor class: INDUSTRY
First posted: 2013-05-16
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: FEV₁ AUC (0 -6 h)
timeFrame: Day 14
Secondary outcomes:
measure: Change from baseline in Residual Volume (RV)
timeFrame: Days 1, 2, 3, & 14
measure: Peak change in FEV₁
timeFrame: Days 1, 2, 3, & 14
measure: Change from baseline in Inspiratory Capacity (IC)
timeFrame: Days 1, 2, 3, & 14
measure: Change from baseline in Functional Residual Capacity (FRC)
timeFrame: Days 1, 2, 3, &14
measure: Change from baseline in FEV₁
timeFrame: Day 14
measure: Change from baseline in FEV₁/FVC
timeFrame: Days 1, 2, 3, & 14
measure: FVC AUC (0-6 h)
timeFrame: Days 1, 2, 3, & 14
measure: Use of rescue medication
timeFrame: From Day 1 to Day 14
Other outcomes:
measure: Safety and Tolerability
timeFrame: 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
Locations:
city: Quebec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
affiliation: Asmacure Ltée
name: Yvon Cormier, M.D.
role: STUDY_CHAIR
References: