Safety, Tolerability and Clinical Activity of ASM-024 in Stable Moderate Asthma
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and clinical activity of ASM-024 in stable moderate asthma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Peak change in FEV1 following inhalation of ASM-024 [Over a period of 6 hours following administration]
Secondary Outcome Measures
- FEV1 AUC following inhalation of ASM-024 [Over 6 hours following administration]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Able and willing to provide written informed consent.
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Male or female subjects, ≥ 18 years and ≤ 55 years of age
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Diagnosis of moderate asthma and on regular inhaled corticosteroids with or without short or long-acting Beta-2-agonists
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FEV1 ≥ 55 % predicted in the absence of medications for asthma
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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
- 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.
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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:
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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:
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Oral or i.v. corticosteroids within 1 month;
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Inhaled or intranasal corticosteroids within 48 hours;
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Long acting Beta-2-agonists within 24 hours;
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Short acting Beta-2-agonists within 8 hours;
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Anticholinergic aerosols within 24 hours; and
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | McMaster University | Hamilton | Ontario | Canada | L8N 3Z5 |
| 2 | Anapharm | Montreal | Quebec | Canada | H3X 2H9 |
| 3 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ASM-024/II/STA-02