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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Asmacure Ltée
ClinicalTrials.gov Identifier:
NCT01190826
First received: August 26, 2010
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Asthma
Drug: ASM-024
Drug: ASM-024 100 mg
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Asmacure Ltée:

Primary Outcome Measures:
  • Peak change in FEV1 following inhalation of ASM-024 [ Time Frame: Over a period of 6 hours following administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1 AUC following inhalation of ASM-024 [ Time Frame: Over 6 hours following administration ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2010
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190826

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Anapharm
Montreal, Quebec, Canada, H3X 2H9
Canada
Centre de Recherche Institut universitaire de cardiologie et de pneumologie de Québec
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Asmacure Ltée
Investigators
Principal Investigator: Richard Larouche, B. Pharm. MD Anapharm
  More Information

No publications provided

Responsible Party: Asmacure Ltée
ClinicalTrials.gov Identifier: NCT01190826     History of Changes
Other Study ID Numbers: ASM-024/II/STA-02
Study First Received: August 26, 2010
Last Updated: March 14, 2012
Health Authority: Canada: Health Canada

Keywords provided by Asmacure Ltée:
Stable moderate asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 11, 2014