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 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT00578968
Eligibility Criteria:
Chronic obstructive pulmonary disease (COPD) participants-
Inclusion criteria:
* Body Mass Index (BMI) \<36
* Moderate to severe COPD patient, (similar to or slightly better than Gold Guidelines Stage 2-3, forced expiratory volume in one second \[FEV\_1\] \<60% of age predicted)
* Smoking history of 10 pack years or more
* Clinical diagnosis of COPD
* Not on daytime oxygen
Exclusion criteria:
* Clinical diagnosis of asthma
* Myocardial infarction within the last 6 months, or known ischemia
* Serious uncontrolled cardiac arrhythmia (i.e., atrial fibrillation or ventricular tachycardia) or hospitalization for heart failure within the previous year
* Known moderate to severe renal impairment
* Known moderate to severe symptomatic prostatic hypertrophy or bladder neck obstruction
* Known narrow angle glaucoma
* Current radiation or chemotherapy for a malignant condition
* Inability to give informed consent
* On systemic corticosteroids at unstable doses or on regular daily doses of 20 mg or more of prednisone (or equivalent)
* Not fully recovered from an exacerbation of COPD for at least 30 days
* Inability to perform light to moderate activity for orthopedic reasons or who significantly desaturated with exercise (percentage of available hemoglobin that is saturated with oxygen \[SaO\_2\] \< 85% on screening test
Healthy controls -
Inclusion:
\- Age and gender matched to COPD participants
Exclusion:
\- Subjects who are unable to engage in exercise testing due to existing comorbidities
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
85 Years
Study:
NCT00578968
Study Brief:
Protocol Section:
NCT00578968