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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03717012
Recruitment Status : Terminated (Due to the current COVID-19 pandemic, the recruitment of new subjects is temporarily discontinued. Ongoing, randomised patients are managed per Trial Protocol.)
First Posted : October 23, 2018
Last Update Posted : October 6, 2020
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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)

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Nintedanib Other: Pulmonary rehabilitation program Phase 4

Expanded Access : An investigational treatment associated with this study is temporarily not available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Pulmonary Rehabilitation In Nintedanib Treated Patients With IPF: Improvements in Activity, Exercise Endurance Time, and QoL
Actual Study Start Date : November 15, 2018
Actual Primary Completion Date : March 27, 2020
Actual Study Completion Date : June 10, 2020

Arm Intervention/treatment
Active Comparator: Nintedanib treatment alone Drug: Nintedanib
stable dose

Experimental: Nintedanib with a pulmonary rehabilitation program Drug: Nintedanib
stable dose

Other: Pulmonary rehabilitation program
12 weeks

Primary Outcome Measures :
  1. Change from baseline in 6MWD Change from baseline in Six Minute Walk Distance (6MWD) at 12 weeks [ Time Frame: Baseline, 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in QoL St George's Respiratory Questionnaire (SGRQ) at 12 and 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ]
  2. Change from baseline in Six Minute Walk Distance (6MWD) at 24 weeks [ Time Frame: Baseline, 24 weeks ]
  3. Change from baseline in lung function Forced Vital Capacity (FVC) at 12 weeks and 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ]
  4. Change from baseline in daily accelerometer activity at 12 and 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ]
  5. Change from baseline in QoL King's Brief Interstitial Lung Disease (ILD) Questionnaire (KBILD) at 12 and 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ]
  6. Change from baseline in QoL University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) at 12 and 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03717012

Hide Hide 19 study locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
United States, Connecticut
Western Connecticut Medical Group
Danbury, Connecticut, United States, 06810
United States, Florida
Miami VA Healthcare System
Miami, Florida, United States, 33125
Coastal Pulmonary & Crit Care
Saint Petersburg, Florida, United States, 33704
United States, Indiana
The LaPorte County Institute for Clinical Research
Michigan City, Indiana, United States, 46360
United States, Maryland
Pulmonary and Critical Care Associates of Baltimore
Towson, Maryland, United States, 21286
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Montana
St. Vincent Physicians Sleep and Respiratory Center
Billings, Montana, United States, 59101
Glacier View Research Institute
Kalispell, Montana, United States, 59901
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, North Carolina
Pulmonix, LLC
Greensboro, North Carolina, United States, 27403
United States, Pennsylvania
Temple University Hospital
Oaks, Pennsylvania, United States, 19456
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Metroplex Pul and Sleep Ctr
McKinney, Texas, United States, 75069-1769
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
United States, Washington
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
United States, Wisconsin
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim Identifier: NCT03717012    
Other Study ID Numbers: 1199-0324
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action