Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Inclusion criteria:

- Currently taking nintedanib, at a stable dose for 3-18 months

- Age ≥ 40 years at screening

- Women of childbearing potential (WOCBP) must be ready and able to use highly effective
methods of birth control per ICH M3 (R2) that result in a low failure rate of less
than 1% per year when used consistently and correctly. A list of contraception methods
meeting these criteria is provided in the patient consent form

- Signed and dated written informed consent in accordance with ICH-GCP (International
Council on Harmonization and Good Clinical Practice) and local legislation prior to
admission to the trial

- Confirmed diagnosis of IPF according to 2011 American Thoracic Society (ATS)/ European
Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic
Association (ALAT) guidelines by lung biopsy or High Resolution Computed Tomography
(HRCT)(based upon INPULSIS criteria, (if biopsy only or HRCT done > 24 months prior to
screening, a new HRCT to be done after consent and prior to or up to 7 days after
Visit 2 for quantitative lung fibrosis score (QLF) for disease characterization)

- Forced Vital Capacity (FVC) ≥ 50% of predicted by the NHANES equation or equivalent
(after discussion with Clinical Monitor), historical within past 30 days can be used.
Carbon monoxide Diffusion Capacity (DLCO) (corrected for hemoglobin [Hgb]) 30-79% of
predicted

- FEV1/FVC greater than/equal to .7

- Physically capable of performing both a 6 minute walk test and work rate cycle
ergometry (sub-study patients), must successfully complete the practice tests for both

Exclusion criteria:

- Major surgery (major according to the investigator's assessment) performed within 12
weeks prior to randomization or planned within 6 months after screening, e.g. hip
replacement which could interfere with the ability to participate in pulmonary
rehabilitation.

- Any documented active or suspected malignancy or history of malignancy within 3 years
prior to screening, except appropriately treated basal cell carcinoma of the skin or
in situ carcinoma of uterine cervix

- Patients who must or wish to continue the intake of restricted medications or any drug
considered likely to interfere with the safe conduct of the trial

- Previous enrolment in this trial

- Currently enrolled in another interventional investigational device or drug trial, or
less than 30 days since ending another investigational device or drug trial(s), or
receiving other investigational treatment(s)

- Chronic alcohol or drug abuse or any condition that, in the investigator's opinion,
makes them an unreliable trial patient or unlikely to complete the trial

- Women who are pregnant, nursing, or who plan to become pregnant in the trial

- Participation in a pulmonary rehabilitation program completed in the past 3 months.