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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT04231760
Eligibility Criteria:
Inclusion Criteria:
* Twenty participants with mild COPD (forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) below the lower limit of normal (\<-1.64 z-score)1) and FEV1 ≥ 80% predicted, with a smoking history (10 \> pack-years) will be recruited. Twenty participants with moderate COPD (FEV1/ FVC below the lower limit of normal (\<-1.64 z-score)1) and FEV1 50-80% predicted, with a smoking history (10 \> pack-years) will also be recruited. Additionally, 40 healthy individuals with be recruited.
* Participants will be free of any known significant cardiovascular, metabolic or neuromuscular disease. Participants with COPD will have global initiative for chronic obstructive lung disease (GOLD) Stage 1 mild COPD (FEV1/FVC ratio \<0.70 and FEV1 ≥ 80% predicted1) and Stage 2 moderate COPD (FEV1/FVC ratio \<0.70 and FEV1 50-80% predicted) and a \>10 pack-year smoking history. Controls will have normal lung function, minimal smoking history and no previous diagnosis of COPD. Participants will range from 18-85 years old.
Exclusion Criteria:
* Individuals with significant cardiovascular, metabolic, neuromuscular or any other disease that could contribute to dyspnea or abnormal cardiopulmonary responses to exercise will be excluded.
* Individuals with musculoskeletal injuries that prevent them from completing cycle ergometry exercise trials will be excluded.
* COPD participants currently on oral steroids (i.e. prednisone), phosphodiesterase type 5 (PDE5) inhibitors or supplemental O2 therapy will be excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04231760
Study Brief:
Protocol Section:
NCT04231760