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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT05838703
Eligibility Criteria:
Inclusion Criteria:
1. Outpatients of either gender, age \> 40.
2. Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed)
3. Women of childbearing potential must have a negative urine pregnancy test. This will be confirmed before participation in this investigational protocol.
4. Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating FEV1/FVC \< 0.70 in all GOLD stages (http://www.goldcopd.org/).
5. Patients who are tiotropium naïve or whose tiotropium can be withheld for 2 weeks before screening visit/visit 1
Exclusion Criteria:
6. Upper respiratory tract infection within 6 weeks (in this case, we will re-screen the patient after 6 weeks)
7. 24/7 oxygen use
8. Previous history of pneumothorax
9. Evidence of interstitial, occupational or chronic infectious lung disease by imaging studies
10. For women of child bearing potential, positive pregnancy test.
11. Major chronic illnesses which in the judgement of the study physician would interfere with participation in the study
12. History of claustrophobia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05838703
Study Brief:
Protocol Section:
NCT05838703