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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT00708227
Eligibility Criteria:
Inclusion Criteria:
* Diplotype: Whites with specific diplotype and African Americans with specific diplotypes.
* Gender: Male or female. Women are eligible if they are not pregnant or lactating. Females subjects of childbearing potential will undergo a urine pregnancy test prior to each methacholine challenge test.
* Age: 10 years and older.
* Asthma Diagnosis: Physician diagnosed asthma according to American Thoracic Society criteria for at least 3 months.
* Asthma Therapy: There is no requirement for previous asthma therapy to be included in this study.
* Asthma Severity: forced expiratory volume in the first second (FEV1) must be \>= 60% of predicted normal values for age, height, and gender.
* methacholine challenge test provocative concentration (20% fall in FEV1) of \<=12\]mg/ml.
Exclusion Criteria:
* History of life-threatening asthma: Any episode of asthma requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures.
* Asthma instability: Hospitalization for asthma within 3 months of Visit 1.
* Concurrent respiratory disease: Any respiratory disease other than asthma.
* Sensitivities: Sensitivities to methacholine, Flovent® MDI, ipratropium bromide, albuterol, or Advair Diskus® that would put the safety of the subject at risk.
* Respiratory Tract Infection: Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks immediately preceding Visit 1, or for which antibiotic therapy has not been completed at least 2 weeks prior to Visit 1.
* Expected exposure to pollen allergen to which the patient is sensitive (by medical history of symptoms) during the 29 day study period. These patients can be studied when pollen exposure to which they are sensitive will not occur.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT00708227
Study Brief:
Protocol Section:
NCT00708227