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 @ 1:56 PM
Ignite Modification Date:
2025-12-24 @ 1:56 PM
NCT ID:
NCT00284895
Eligibility Criteria:
Inclusion Criteria:
* Adults (≥18yr) who report a physician's diagnosis of asthma and have taken any asthma medication within the last 2 weeks.
* Obesity (Body Mass Index (BMI) ≥40, or ≥35 with comorbidities, as per published guidelines for qualification for bariatric surgery).
* Planned weight-loss surgery or structured weight-loss plan.
Exclusion Criteria:
* Tobacco use within one month.
* Qualifying lung-functioning.
* Qualifying oxygen saturation levels.
* Use of systemic corticosteroids (Prednisone) within one month.
* Presence of another chronic lung disease besides asthma (COPD, bronchiectasis, ILD, sarcoidosis, etc).
* Presence of another chronic systemic inflammatory disease (rheumatoid arthritis or other connective-tissue disease, chronic infection such as osteomyelitis, inflammatory bowel disease, chronic active hepatitis, etc). Subjects with osteoarthritis, stable coronary artery disease, hypertension, or diabetes mellitus will not be excluded.
* Presence of malignant neoplasm within the last 3 years (with the exception of non-melanoma skin cancer).
* Clinically significant left or right ventricular dysfunction.
* Severe pulmonary hypertension (high blood pressure).
* Untreated obstructive sleep apnea:
* Subjects with a current diagnosis of sleep apnea not being treated with CPAP or BiPAP will be excluded.
* Subjects with a current diagnosis of sleep apnea being treated adequately (as determined by the investigators) will be included.
* Prader-Willi syndrome
* A known endocrinopathy causing obesity (e.g., Cushing's Syndrome).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00284895
Study Brief:
Protocol Section:
NCT00284895