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

NCT01855230 | Completed Phase 2 DMC

• 1 other identifier: ASM-024/II/STA-04
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• FEV₁ AUC (0 -6 h)

  Day 14

Secondary Outcomes (8)

• Change from baseline in Residual Volume (RV)

  Days 1, 2, 3, & 14

• Peak change in FEV₁

  Days 1, 2, 3, & 14

• Change from baseline in Inspiratory Capacity (IC)

  Days 1, 2, 3, & 14

• Change from baseline in Functional Residual Capacity (FRC)

  Days 1, 2, 3, &14

• Change from baseline in FEV₁

  Day 14

Other Outcomes (1)

• 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

Study Arms (2)

ASM-024

EXPERIMENTAL

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

Drug: ASM-024

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ASM-024 DRUG

ASM-024 b.i.d for 14 days

ASM-024

Placebo DRUG

Placebo b.i.d. for 14 days

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asmacure Ltée: lead

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

ASM-024

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yvon Cormier, M.D.

  Asmacure Ltée

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 16, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

CA (1)