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:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT01926002
Eligibility Criteria:
Inclusion Criteria:
* Females of non-childbearing potential (at least 1 year post-menopausal, post-hysterectomy, post-oophorectomy, or with tubal ligation);
* Males with a female partner of childbearing potential must agree to use a medically acceptable method of contraception during and up to 120 days after the last dose of study medication;
* Body Mass Index (BMI) \>=17 kg/m\^2 and \<=33 kg/m\^2
* Non-smoker and non-user of nicotine or nicotine-containing products for at least 6 months prior to enrollment;
* History of allergen-induced asthma for at least 6 months prior to enrollment;
* Able to perform reproducible pulmonary function testing;
* Positive methacholine challenge test prior to receiving study medication;
* Allergic response to house dust mite allergen or standardized cat pelt or hair allergen extract;
* Ability to tolerate sputum induction and to produce adequate sputum.
Exclusion Criteria:
* History of clinically significant disease or disorder;
* History of malignancy;
* History of significant multiple and/or severe allergies;
* History of milk or lactose allergies or intolerance;
* History of anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food;
* Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies;
* History of major surgery within 3 months prior to enrollment;
* Participation in another investigational trial within 4 weeks of screening;
* Lactating females;
* Inability to refrain from, or anticipates the use of, any medication including herbal remedies during the trial period;
* History of receiving anti-immunoglobulin E (IgE) or immunotherapy;
* History of serious allergies to drug or a history of hypersensitivity to inhaled salbutamol, antihistamines, or any other potential asthma/anaphylaxis rescue medication;
* History of hospitalization for asthma-related illness within 3 months of screening;
* History of emergent care more than twice in the last 12 months for asthma-related illness;
* History of life-threatening asthma;
* Consumes \>4 glasses of alcoholic beverage per day;
* Consumes \>6 servings of coffee, tea, cola, energy drinks or other caffeinated beverages per day;
* History or or current use of illicit drugs within past 24 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01926002
Study Brief:
Protocol Section:
NCT01926002