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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT02551068
Eligibility Criteria:
Inclusion Criteria:
* Age 19 years or older
* Idiopathic Pulmonary Fibrosis (IPF) diagnosis according to American Thoracic Society and/or European Respiratory Society consensus criteria
* Appropriate candidate for pulmonary rehabilitation
* prescribed nintedanib by their treating physician or currently on nintedanib
* 6 minute walk distance 50m or more
* Oxygen saturation 92% or more by pulse oximetry at rest while breathing room air
* Clinically stable for the preceding 6 weeks
Exclusion Criteria:
* Contraindication to treatment with nintedanib (based on Canadian labeling)
* Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease)
* Other significant extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
* Forced vital capacity (FVC) less than 50% or Diffusion capacity for carbon monoxide (DLCO) less than 25%
* Concurrent or recent participation (less than 6 months) in a pulmonary rehabilitation program
* Use of prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit
* Use of pirfenidone within 4 weeks of screening
* Significant emphysema (less than 10% volume on high resolution computed tomography (HRCT) or forced expiratory volume at one second (FEV1)/FVC less than 0.70)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02551068
Study Brief:
Protocol Section:
NCT02551068