Status:
COMPLETED
Multiple Dose ASM8 in Mild Asthmatics
Lead Sponsor:
Syntara
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
To determine the safety and efficacy of multiple doses of ASM8 antisense oligonucleotides in asthmatics.
Detailed Description
This is a double-blind, placebo-controlled, crossover trial to evaluate the safety, tolerability and efficacy of inhaled ASM8 for the treatment of allergen-induced asthma. Individuals with stable, mil...
Eligibility Criteria
Inclusion
- Part 1: Men and women 18 to 65 years of age; generally good health; mild to moderate, stable, allergic asthma as defined by ATS criteria (1); history of episodic wheeze and shortness of breath; forced expiratory volume in 1 second (FEV1) at baseline ≥70% of the predicted value; able to comprehend and follow all required study procedures; willing and able to sign an informed consent form.
- Part 2: Methacholine challenge at baseline (PC20 ≤16 mg/mL); positive skin-prick test to common aeroallergens (cat, dust mite, grass, pollen) and positive allergen-induced early and late airway bronchoconstriction.
Exclusion
- Part 1 and Part 2: Significant acute or chronic medical or psychiatric illness; known coagulopathy, worsening of asthma or respiratory infection in the preceding 6 weeks; use of inhaled or oral corticosteroids within the last 28 days, antihistamines, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed); use of medications that may interact with ASM8; investigational drug use within 30 days; any clinically significant abnormality on screening laboratory determinations; current tobacco use in previous 3 months or 10 pack-years; pregnant or lactating women; women actively seeking pregnancy or who are not using adequate contraception; history of serious adverse effect (SAE) or hypersensitivity to any drug; 20% decrease in FEV1 or FVC with baseline saline in methacholine challenge during screening.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00264966
Start Date
December 1 2005
End Date
April 1 2006
Last Update
December 3 2012
Active Locations (3)
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1
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
2
Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
3
Saskatoon Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8