Safety, Tolerability and Clinical Activity of ASM-024 in Stable Moderate Asthma

Single-Center, Randomized, Double-Blind, Placebo-Controlled, Three-Way Crossover Study to Evaluate the Safety, Tolerability and Clinical Activity of a Single Dose of ASM-024 Administered by Inhalation to Subjects With Stable Moderate Asthma

The purpose of this study is to evaluate the safety, tolerability and clinical activity of ASM-024 in stable moderate asthma.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: ASM-024; Drug: ASM-024 100 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Centre de Recherche Institut universitaire de cardiologie et de pneumologie de Québec
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University
  • Quebec
    • Montreal, Quebec, Canada, H3X 2H9
      • Anapharm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able and willing to provide written informed consent.
• Male or female subjects, ≥ 18 years and ≤ 55 years of age
• Diagnosis of moderate asthma and on regular inhaled corticosteroids with or without short or long-acting Beta-2-agonists
• FEV1 ≥ 55 % predicted in the absence of medications for asthma
• Female subjects of childbearing potential must have a negative pregnancy test (serum beta-human chorionic gonadotropin (b-HCG)) at Screening, and a negative pregnancy test immediately before the administration of the study drug for each of Periods 1, 2 and 3. Sexually active females with non-sterile partner must be willing to use adequate contraception.
• Male subjects must be willing to use a condom with a spermicide for the duration of their participation in the study, plus an additional 30 days following study drug administration and ensure that their partner is using a highly effective method of birth control such as combined oral contraceptives, implants, injectables or an intra-uterine device (IUD). Male subjects must ensure that their female partner is willing to use adequate contraception.
• Demonstration of an increase in FEV1 by ≥ 10 % predicted between spirometry performed before and 10-20 minutes after the administration of 2 puffs of 100 micrograms of salbutamol at Screening.

Exclusion Criteria:

• Clinically significant conditions or illnesses other than moderate asthma or systemic diseases
• Pregnant or nursing women or women intending to conceive during the course of the study or have a positive serum pregnancy test at Screening or a positive urine pregnancy test during the study.
• Women of childbearing potential (unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years) not using a highly effective method of birth control.
• Non-surgically sterile males and males with partners of childbearing potential not willing to use a condom with spermicide for the duration of their participation in the study plus an additional 30 days following study drug administration and to ensure that their partner is using a highly effective method of birth control such as combined oral contraceptives, implants, injectables or an IUD.
• Respiratory tract infections or worsening of asthma or changes in asthma medications within 6 weeks before Screening/Baseline.
• Current cigarette smokers or former smokers with a smoking history of greater than 10 pack years or who stopped smoking within 12 months preceding enrolment in the study.
• Positive urine cotinine test at Screening.
• History of illicit drug use or alcohol abuse within 12 months before Screening.
• Positive test for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV) at Screening.
• Any medication that are known to prolong QT / QTc interval.

• Any of the following concomitant medications preceding the administration of salbutamol during Screening and preceding the administration of the study drug:

  • Oral or i.v. corticosteroids within 1 month;
  • Inhaled or intranasal corticosteroids within 48 hours;
  • Long acting Beta-2-agonists within 24 hours;
  • Short acting Beta-2-agonists within 8 hours;
  • Anticholinergic aerosols within 24 hours; and
  • Theophylline-containing products within 48 hours.
• Use of NSAIDs within 7 days preceding the administration of salbutamol during Screening and throughout the study.
• Use of antihistaminic drugs within 3 days preceding the administration of salbutamol during Screening.
• Use of an investigational product or participation in a clinical trial using an investigational product within 30 days before dosing or within 90 days in the case of long-acting products (ex.: Depo-medrol) or biologics with a long-acting half-life (ex.: monoclonal antibodies).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASM-024 10 mg; ASM-024 administered once by inhalation at a target dose of 10 mg	Drug: ASM-024; Target dose of 10 mg ASM-024 administered once by inhalation
Experimental: ASM-024 100 mg; ASM-024 administered once at a target dose of 100 mg	Drug: ASM-024 100 mg; Target dose of 100 mg ASM-024 administered once by inhalation
Placebo Comparator: Placebo; Placebo administered once by inhalation	Drug: Placebo; Placebo administered once by inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak change in FEV1 following inhalation of ASM-024	Over a period of 6 hours following administration

Secondary Outcome Measures

Outcome Measure	Time Frame
FEV1 AUC following inhalation of ASM-024	Over 6 hours following administration

Collaborators and Investigators

• Sponsor: Asmacure Ltée
• Investigators: Principal Investigator: Richard Larouche, B. Pharm. MD, Anapharm

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: August 26, 2010
• First Submitted That Met QC Criteria: August 27, 2010
• First Posted (Estimate): August 30, 2010

Study Record Updates

• Last Update Posted (Estimate): March 15, 2012
• Last Update Submitted That Met QC Criteria: March 14, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Stable moderate asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: ASM-024/II/STA-02