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



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:4/4/2019
Start Date:November 15, 2018
End Date:November 19, 2020
Contact:Boehringer Ingelheim
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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Study of Pulmonary Rehabilitation In Nintedanib Treated Patients With IPF: Improvements in Activity, Exercise Endurance Time, and QoL

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)


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.
We found this trial at
15
sites
Tacoma, Washington 98405
Phone: +001 (253) 403-0389
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800 North Fant Street
Anderson, South Carolina 29621
Phone: +001 (864) 225-5667
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Phone: +001 (734) 763-5118
University of Michigan Health System The University of Michigan is home to one of the...
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Phone: +001 (303) 724-6109
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Baltimore, Maryland 21201
Phone: +001 (410) 328-8141
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303 East Superior Street
Chicago, Illinois 60611
Phone: +001 (312) 695-1879
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Danbury, Connecticut 06810
Phone: +001 (203) 739-7070
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McKinney, Texas 75069
Phone: +001 (972) 838-1892
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Miami, Florida 33136
Phone: +001 (305) 575-3548
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Michigan City, Indiana 46360
Phone: +001 (219) 728-8261
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Minneapolis, Minnesota 55407
Phone: +001 (952) 567-7400
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Oaks, Pennsylvania 19456
Phone: +001 (610) 630-2222
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Phone: +001 (215) 707-3332
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Saint Petersburg, Florida 33704
Phone: +001 (727) 822-6661
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Towson, Maryland 21204
Phone: +001 (410) 494-1662-x2625
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