Clinical Trials

Inclusion Criteria:

• Patients being treated with a stable dose of nintedanib 150 mg BID for up to 30 months. 
• Patients who have recently started nintedanib 150 mg BID and have started by the day of randomization must be on nintedanib 150 mg BID a minimum of 10 days by the first day of pulmonary rehabilitation. 
• 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) (R17-1399) 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 ATS/ERS/JRS/ALAT guidelines by lung biopsy or HRCT (based upon INPULSIS criteria (c02098775-02, c02155574-02), (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) ≥ 45% of predicted by the NHANES equation (R04-1001) 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 the 6 minute walk test, per the instructions. Potential sub-study patients that require supplemental oxygen or cannot complete the incremental work rate cycle ergometry test will not participate in the sub-study, but will qualify for the main study.

* A woman is considered of childbearing potential (WOCBP); i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile.  Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.  A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

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.
• Previous participation in pulmonary rehabilitation program within 45 days prior to signing consent