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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT05267418
Eligibility Criteria:
Inclusion Criteria:
One of them
* Moderate to severe COPD (forced expiratory volume in 1 second (FEV1) \< 80% predicted and FEV1/forced vital capacity (FVC) ratio \< 0.7)
* Chronic interstitial lung disease such as usual interstitial pneumonitis (UIP), non-specific interstitial pneumonitis (NSIP) or hypersensitivity pneumonitis on high-resolution computed tomography
* Pulmonary arterial hypertension type 1 or 4, excluding involvement secondary to collagenosis as well as secondary to congenital heart disease, as diagnosed with mean pulmonary artery pressure \> 25 mm Hg at right heart catheterization
* Cystic fibrosis, as diagnosed by a positive sweat test (\>60 mmol/L) or having 2 genetic mutations known to cause cystic fibrosis.
AND having a 6-minute walking test with significant desaturation defined as a decrease in O2 saturation greater or equal to 5% with O2 saturation at the end of the walking test \< 88%
Exclusion Criteria:
* Exacerbation of the primary lung disease in the past 8 weeks
* Exercise limiting diseases other than the primary lung disease.
* Not reaching the target dyspnea score during the walking tests.
* Stage 1 pulmonary sarcoidosis
* History of syncope on exertion
* SpO2 with effort less than 90% despite the use of 6 L of O2 per minute
* Cardiac condition deemed unstable or severe (e.g. severe aortic stenosis)
* Disabling or severe rheumatological or neurological condition
* Participation in a pulmonary rehabilitation program within the last year
* Patients with multi-resistant bacteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05267418
Study Brief:
Protocol Section:
NCT05267418