Safety, Tolerability and Clinical Activity of ASM-024 in Stable Moderate Asthma
- Registration Number
- NCT01190826
- Lead Sponsor
- Asmacure Ltée
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability and clinical activity of ASM-024 in stable moderate asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
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Clinically significant conditions or illnesses other than moderate asthma or systemic diseases
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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.
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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.
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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.
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Respiratory tract infections or worsening of asthma or changes in asthma medications within 6 weeks before Screening/Baseline.
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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.
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Positive urine cotinine test at Screening.
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History of illicit drug use or alcohol abuse within 12 months before Screening.
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Positive test for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV) at Screening.
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Any medication that are known to prolong QT / QTc interval.
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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.
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Use of NSAIDs within 7 days preceding the administration of salbutamol during Screening and throughout the study.
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Use of antihistaminic drugs within 3 days preceding the administration of salbutamol during Screening.
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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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ASM-024 10 mg ASM-024 ASM-024 administered once by inhalation at a target dose of 10 mg ASM-024 100 mg ASM-024 100 mg ASM-024 administered once at a target dose of 100 mg Placebo Placebo Placebo administered once by inhalation
- Primary Outcome Measures
Name Time Method Peak change in FEV1 following inhalation of ASM-024 Over a period of 6 hours following administration
- Secondary Outcome Measures
Name Time Method FEV1 AUC following inhalation of ASM-024 Over 6 hours following administration
Trial Locations
- Locations (3)
Anapharm
🇨🇦Montreal, Quebec, Canada
McMaster University
🇨🇦Hamilton, Ontario, Canada
Centre de Recherche Institut universitaire de cardiologie et de pneumologie de Québec
🇨🇦Quebec, Canada