Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Nintedanib; Pulmonary rehabilitation program
Intervention description: stable dose; 12 weeks
Intervention MeSH terms: Nintedanib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The main objectives of this study are:

        -  Determine the difference in change from baseline in Six Minute Walk Distance (6MWD) when
           pulmonary rehabilitation (PR) is added to stable underlying nintedanib therapy in
           patients with idiopathic pulmonary fibrosis (IPF)

        -  Determine the difference in change in Quality of Life (QoL) when pulmonary
           rehabilitation (PR) is added to stable underlying nintedanib therapy in patients with
           idiopathic pulmonary fibrosis (IPF)

        -  Determine if there is an enduring effect in 6MWD, QoL and lung function from pulmonary
           rehabilitation (PR) when pulmonary rehabilitation (PR) is added to stable underlying
           nintedanib therapy in patients with idiopathic pulmonary fibrosis (IPF)
    

Eligibility criteria:

        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) 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) ≥ 45% 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 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.

        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 (except for rescreening)

          -  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