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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT02340520
Eligibility Criteria:
Inclusion Criteria:
* Established diagnosis of COPD with FEV1 \<60% predicted
* FEV1/FVC \<70% and \<+15% FEV1 response to bronchodilator.
* Patients of both genders will be included.
* IRB approved written informed consent will be obtained from each subject.
Exclusion Criteria:
1. Recent (\<1 month) exacerbation of COPD,
2. Known hypersensitivity to beta agonists, theophylline, steroids, or roflumilast.
3. Current or recent (\<2 weeks) treatment with oral steroids, theophylline or other methylxanthines, or roflumlast.
4. Diagnosis or history of asthma, uncontrolled hypertension, or congestive heart failure.
5. History of Cardiac arrhythmia
6. History of seizures.
7. History of Liver disease
8. Gastrointestinal disease, including history of peptic ulcer disease.
9. Current infection or antibiotic treatment.
10. History of depression or psychiatric disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT02340520
Study Brief:
Protocol Section:
NCT02340520