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

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Age: 40 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: IPF, idiopathic pulmonary fibrosis
Type: Drug study, Phase 4
Target:
6 Participants
Investigator:
Description
This study is for patients who have Idiopathic Pulmonary Fibrosis (IPF) and are taking Ofev®.

Patients with IPF are often referred by their doctors to pulmonary rehabilitation programs. Some patients report that the programs have helped them. This potential benefit has not been studied very much before.

This study is being done in patients who have IPF and are taking Ofev® to see:

• if pulmonary rehabilitation improves physical activity and quality of life .

• if any benefits last after stopping the pulmonary rehabilitation.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria

  1. Currently taking nintedanib 150 mg BID, at a stable dose for 3-30 months2

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

  6. Forced Vital Capacity (FVC) ≥ 50% 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

  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 both, per the instructions. Potential sub-study patients that require supplemental oxygen or cannot complete the incremental or practice work rate cycle ergometry test will not participate in the sub-study, but will qualify for the main study.

Exclusion criteria

  1. 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.

  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 enrolment in this trial (except for rescreening)

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

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study team will discuss the risks associated with taking part in this research study.
Compensation
We will pay you for the study visits you complete according to the following schedule: Screening $75, Visit 1 $225, Visit 2 $225, Visit 3 $75, Visit 4 $75, Visit 5 $225, Visit 6 $75, Visit 7(EOT) $225. If you come to the study center for any unscheduled visits, you will be paid $ 75.00 for each additional visit.
Resources
Schedule
Study duration and period
You will be in this study about 26 weeks and have about 8 visits to the study center.
Recruitment period
From Aug. 21, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Bulleri, Alicia
Research Topic
Conditions:
  • Idiopathic Pulmonary Fibrosis