Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2025-12-24 @ 4:28 PM
NCT ID:
NCT00264966
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00264966
Study Brief:
Protocol Section:
NCT00264966