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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT01797367
Eligibility Criteria:
Inclusion Criteria:
* Simultaneous co-enrollment in the START study
* Signed informed consent to the Pulmonary Substudy
* Age \>= 25 years
Exclusion Criteria:
* An episode of respiratory illness with 2 or more symptoms of cough, wheezing, breathlessness, or increase in sputum production within the 6 weeks before baseline spirometry.
* Use of asthma medications (bronchodilator, inhaled corticosteroid, leukotriene inhibitor, or theophylline) for 2 or more consecutive weeks within the 6 months before baseline spirometry.
* Relative contraindications to spirometry, such as chest or abdominal or eye surgery within the 3 months before baseline spirometry, known retinal detachment at the time of baseline spirometry.
* Known allergy to albuterol/salbutamol
* Relative contraindications to albuterol/salbutamol, such as resting heart rate of \>110 beats per minute, or a known serious or recurrent or uncontrolled cardiac condition (such as unstable coronary artery disease, decompensated heart failure, or recurrent tachyarrhythmias).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT01797367
Study Brief:
Protocol Section:
NCT01797367