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

COPD Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855230
• Other study ID #: ASM-024/II/STA-04
• Status: Completed
• Phase: Phase 2
• First received: May 10, 2013
• Last updated: December 15, 2014
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Asmacure Ltée
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• ASM-024
ASM-024 b.i.d for 14 days
• Placebo
Placebo b.i.d. for 14 days

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Asmacure Ltée

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and Tolerability		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	Yes
Primary	FEV1 AUC (0 -6 h)		Day 14	No
Secondary	Change from baseline in Residual Volume (RV)		Days 1, 2, 3, & 14	No
Secondary	Peak change in FEV1		Days 1, 2, 3, & 14	No
Secondary	Change from baseline in Inspiratory Capacity (IC)		Days 1, 2, 3, & 14	No
Secondary	Change from baseline in Functional Residual Capacity (FRC)		Days 1, 2, 3, &14	No
Secondary	Change from baseline in FEV1		Day 14	No
Secondary	Change from baseline in FEV1/FVC		Days 1, 2, 3, & 14	No
Secondary	FVC AUC (0-6 h)		Days 1, 2, 3, & 14	No
Secondary	Use of rescue medication		From Day 1 to Day 14	No