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

NCT ID: NCT01855230

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ASM-024

Dry Powder for Inhalation, b.i.d., 14 days

Group Type EXPERIMENTAL

ASM-024

Intervention Type DRUG

ASM-024 b.i.d for 14 days

Placebo

Dry Powder for Inhalation, b.i.d., 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo b.i.d. for 14 days

Interventions

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ASM-024

ASM-024 b.i.d for 14 days

Intervention Type DRUG

Placebo

Placebo b.i.d. for 14 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asmacure Ltée

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yvon Cormier, M.D.

Role: STUDY_CHAIR

Asmacure Ltée

Locations

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Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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ASM-024/II/STA-04

Identifier Type: -

Identifier Source: org_study_id