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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190826
• Other study ID #: ASM-024/II/STA-02
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2010
• Last updated: March 14, 2012
• Start date: August 2010
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• 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 in stable moderate asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 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

• Asthma

Intervention

Drug:
• ASM-024
Target dose of 10 mg ASM-024 administered once by inhalation
• ASM-024 100 mg
Target dose of 100 mg ASM-024 administered once by inhalation
• Placebo
Placebo administered once by inhalation

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	Anapharm	Montreal	Quebec
Canada	Centre de Recherche 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
Primary	Peak change in FEV1 following inhalation of ASM-024		Over a period of 6 hours following administration	No
Secondary	FEV1 AUC following inhalation of ASM-024		Over 6 hours following administration	No