Principal Investigator: Sean Callahan
Keywords: pulmonary , pulmonary rehab , ofev , nintedanib , pulmonary fibrosis , IPF , idiopathic pulmonary fibrosis Department: Pulmonary
IRB Number: 00116307
Specialty: Pulmonary, Pulmonary, Pulmonary, Pulmonary
Sub Specialties: Advanced Lung Disease, Pulmonary Fibrosis, Pulmonary Function, Pulmonary
Recruitment Status: Not yet recruiting

Contact Information

Scott Sweeten
scott.sweeten@hsc.utah.edu
8015815811

Brief Summary

The focus of this study is to assess the benefit of PR in IPF patients receiving stable nintedanib therapy (for 3-30 mos.) and to determine whether the PR benefit is maintained following cessation of PR. In addition, the “beyond the pill” or patient focused impact will be evaluated by measuring the effects of PR on patient activity levels and HRQoL. The enduring effect of these outcomes is important to the well-being of the patient. Conceptually nintedanib reductions in FVC decline may allow for an enduring effect following PR. The main objectives of this study are:

 Determine the difference in change from baseline in 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 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)

Primary endpoint(s)

o Change from baseline in 6MWD at 12 weeks 

Secondary endpoint(s)

o Change from baseline in QoL (SGRQ, KBILD, UCSD SOBQ) at 12 and 24 weeks

o Change from baseline in 6MWD at 24 weeks

o Change from baseline in lung function (FVC) at 12 weeks and 24 weeks using each of

 Absolute change from baseline of FVC and FVC % predicted

 Relative change from baseline of FVC and FVC % predicted

 Absolute categorical change of FVC % predicted up to 12 and 24 weeks: decrease by >5%, increase by >5%, and change within ≤ 5

 Absolute categorical change of FVC% predicted up to 12 and 24 weeks: decrease by >10, increase by >10, and change within ≤ 10

o Change from baseline in daily accelerometer activity at 12 and 24 weeks

*Should the need arise, the study team will submit an amendment to update the application to include the vulnerable populations and add a partner consent/parental permission form in the event of a pregnancy. 

Inclusion Criteria

1. 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.

2. Age ≥ 40 years at screening

3. Women of childbearing potential(WOCBP)1 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

4. 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

5. 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 2for quantitative lung fibrosis score (QLF) for disease characterization)

6. Forced Vital Capacity (FVC) ≥ 45% of predictedby 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

7. FEV1/FVC greater than/equal to .7
 

8. 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

Exclusion Criteria

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

2. 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

3. 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

4. Previous enrollment in this trial (except for rescreening as described in Section 3.3. of protocol)

5. 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)

6. 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

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

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