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)

Asmacure Ltée1 site in 1 country14 target enrollmentAugust 2013

ConditionsCOPD

InterventionsASM-024 Placebo

DrugsASM-024 Placebo

Overview

Phase: Phase 2
Intervention: ASM-024
Conditions: COPD
Sponsor: Asmacure Ltée
Enrollment: 14
Locations: 1
Primary Endpoint: FEV₁ AUC (0 -6 h)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

December 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Asmacure Ltée

Responsible Party

Sponsor

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;