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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT01420003
Eligibility Criteria:
Inclusion Criteria:
* Male and female volunteers 18 through 65 years of age.
* Females must not be actively seeking pregnancy, must be using adequate and effective contraception
* General good health
* Mild to moderate, stable, allergic asthma
* History of episodic wheeze and shortness of breath; FEV1 at baseline at least 70% of the predicted value
* Able to understand and give written informed consent and has signed a written informed consent form approved by the investigator's REB
* Positive methacholine challenge
* Positive skin-prick test to common aeroallergens (including cat, dust mite, grass, pollen)
* Positive allergen-induced airway bronchoconstriction (a fall in FEV1 of at least 20% from baseline)
Exclusion Criteria:
* A worsening of asthma or a respiratory tract infection within 6 weeks preceding study entry
* History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness
* History or symptoms of clinically significant autoimmune disease
* History of clinically significant hematologic abnormality, including coagulopathy
* Be pregnant or lactating
* Use of corticosteroids, immunosuppressives, anticoagulants (warfarin or heparin) within 28 days prior to randomization into the study
* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 48 hours of dosing or aspirin with 7 days of dosing
* Have chronic use of any other medication for treatment of allergic lung disease other than short- and intermediate-acting ß2-agonists or ipratropium bromide
* Use of caffeine-containing products or medications for 12 hours or alcohol or over the counter drugs including aspirin, cold and allergy medications for 48 hours or inhaled bronchodilators for 8 hours prior to methacholine and allergen challenges
* Use of tobacco products of any kind currently or within the previous 12 months, or smoking history \> 10 pack years.
* Lung disease other than mild to moderate allergic asthma
* Unwillingness or inability to comply with the study protocol for any other reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01420003
Study Brief:
Protocol Section:
NCT01420003