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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT01537133
Eligibility Criteria:
Inclusion Criteria:
Asthmatic:
* History of physician-diagnosed asthma.
* Methacholine PC20 \< 8mg/ml and/or FEV1 improvement ≥ 12% in response to 180 mcg albuterol.
* FEV1 ≥ 70% of predicted after 180 mcg albuterol.
* Stable asthma for ≥ 3 months prior to enrollment (no urgent care visits, no systemic corticosteroid treatment).
* Asthma Control Questionnaire 6 Score \< 1.5.
* Able to provide informed consent.
* Able to perform spirometry as per ATS criteria.
* Evidence by allergen skin test of sensitivity to an aeroallergen.
* Willingness, if female and able to conceive, to utilize one medically-acceptable form of contraception.
Healthy Control:
* Evidence by allergen skin test of sensitivity to an aeroallergen.
* Able to provide informed consent.
* Able to perform spirometry as per ATS criteria.
Exclusion Criteria:
Asthmatic:
* Presence of lung disease other than asthma.
* Use of \> 10 doses of nasal corticosteroids in the previous 3 months.
* Presence of significant medical illness or other chronic diseases whose treatment could affect the clinical features measured, responses to the therapies to be given in this study, or risks of participating in the study.
* History of atrial or ventricular tachyarrhythmia.
* Changes suggestive of cardiac ischemia on ECG at baseline.
* History of upper respiratory infection, sinusitis, bronchitis, or antibiotic use in the previous 3 months.
* History of chronic sinus disease.
* Smoking \> 5 pack-years, or within the past year
* History of long-term controller medication use for asthma (inhaled or oral corticosteroid, leukotriene pathway antagonist, cromolyn, or theophylline within the preceding 6 months.
* History of bleeding disorder.
* Reduced creatinine clearance.
* Inability, in the opinion of the Study Investigator, to coordinate use of inhaler or otherwise comply with medication regimens.
* Contraindication to bronchoscopy on history or examination.
Healthy Control:
* History of chronic respiratory disease including asthma.
* Presence of significant medical illness or other chronic diseases whose treatment could affect the clinical features measured, responses to the therapies to be given in this study, or risks of participating in the study.
* History of atrial or ventricular tachyarrhythmia.
* Changes suggestive of cardiac ischemia on ECG at baseline.
* History of upper respiratory infection, sinusitis, bronchitis, or antibiotic use in the previous 3 months.
* Methacholine PC20 \< 16 mg/ml or FEV1 improvement ≥ 12% in response to albuterol.
* History of chronic sinus disease
* Smoking \> 5 pack-years, or within the past year
* Use of \> 10 doses of a nasal corticosteroid preparation in the previous 3 months
* FEV1 or FVC \< 80% predicted.
* History of bleeding disorder.
* Reduced creatinine clearance.
* Contraindication to bronchoscopy on history or examination.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01537133
Study Brief:
Protocol Section:
NCT01537133