Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF)
NCT ID: NCT03717012
Last Updated: 2021-06-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
19 participants
INTERVENTIONAL
2018-11-15
2020-06-10
Brief Summary
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* 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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nintedanib treatment alone
Nintedanib
stable dose
Nintedanib with a pulmonary rehabilitation program
Nintedanib
stable dose
Pulmonary rehabilitation program
12 weeks
Interventions
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Nintedanib
stable dose
Pulmonary rehabilitation program
12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Western Connecticut Medical Group
Danbury, Connecticut, United States
Miami VA Healthcare System
Miami, Florida, United States
Coastal Pulmonary & Crit Care
St. Petersburg, Florida, United States
The LaPorte County Institute for Clinical Research
Michigan City, Indiana, United States
Pulmonary and Critical Care Associates of Baltimore
Towson, Maryland, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
St. Vincent Physicians Sleep and Respiratory Center
Billings, Montana, United States
Glacier View Research Institute
Kalispell, Montana, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Pulmonix, LLC
Greensboro, North Carolina, United States
Temple University Hospital
Oaks, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Metroplex Pul and Sleep Ctr
McKinney, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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1199-0324
Identifier Type: -
Identifier Source: org_study_id
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