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

NCT ID: NCT01190826

Last Updated: 2012-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-02-29

Brief Summary

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

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ASM-024 10 mg

ASM-024 administered once by inhalation at a target dose of 10 mg

Group Type: EXPERIMENTAL

ASM-024

Intervention Type: DRUG

Target dose of 10 mg ASM-024 administered once by inhalation

ASM-024 100 mg

ASM-024 administered once at a target dose of 100 mg

Group Type: EXPERIMENTAL

ASM-024 100 mg

Intervention Type: DRUG

Target dose of 100 mg ASM-024 administered once by inhalation

Placebo

Placebo administered once by inhalation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo administered once by inhalation

Interventions

ASM-024

Target dose of 10 mg ASM-024 administered once by inhalation

Intervention Type: DRUG

ASM-024 100 mg

Target dose of 100 mg ASM-024 administered once by inhalation

Intervention Type: DRUG

Placebo

Placebo administered once by inhalation

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asmacure Ltée

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Larouche, B. Pharm. MD

Role: PRINCIPAL_INVESTIGATOR

Anapharm

Locations

McMaster University

Hamilton, Ontario, Canada

Anapharm

Montreal, Quebec, Canada

Centre de Recherche Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

ASM-024/II/STA-02

Identifier Type: -

Identifier Source: org_study_id