Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03717012
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : April 16, 2019
Sponsor:
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 available outside the clinical trial.   More info ...

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 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
Estimated Primary Completion Date : November 19, 2020
Estimated Study Completion Date : November 19, 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.


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

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.

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 ClinicalTrials.gov identifier (NCT number): NCT03717012


Contacts
Layout table for location contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Layout table for location information
United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Niranjan Jeganathan    +001 (909) 558-4489    njeganathan@llu.edu   
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Rishi Raj    +001 (650) 721-5464    rishi.raj@stanford.edu   
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Joyce Lee    +001 (303) 724-6109    Joyce.Lee@ucdenver.edu   
United States, Connecticut
Western Connecticut Medical Group Recruiting
Danbury, Connecticut, United States, 06810
Contact: Thomas Botta    +001 (203) 739-7070    thomas.botta@wchn.org   
United States, Florida
Miami VA Healthcare System Recruiting
Miami, Florida, United States, 33125
Contact: Robert Jackson    +001 (305) 575-3548    rjackson2@med.miami.edu   
Coastal Pulmonary & Crit Care Recruiting
Saint Petersburg, Florida, United States, 33704
Contact: Warren Abel    +001 (727) 822-6661    Wabelresearch@gmail.com   
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Sangeeta Bhorade    +001 (312) 695-1879    sbhorade@nm.org   
United States, Indiana
The LaPorte County Institute for Clinical Research Recruiting
Michigan City, Indiana, United States, 46360
Contact: Ikeadi Ndukwu    +001 (219) 728-8261    indukwu@yahoo.com   
United States, Maryland
Universitiy of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Edward Britt    +001 (410) 328-8141    eBritt@medicine.umaryland.edu   
Pulmonary and Critical Care Associates of Baltimore Recruiting
Towson, Maryland, United States, 21286
Contact: Mitchell Schwartz    +001 (410) 494-1662-x2625    Schwartz@pccabresearch.com   
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Eric White    +001 (734) 763-5118    docew@med.umich.edu   
United States, Minnesota
Minnesota Lung Center Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Mitchell Kaye    +001 (952) 567-7400    dr.kaye@mnlungresearch.com   
United States, Pennsylvania
Temple University Hospital Recruiting
Oaks, Pennsylvania, United States, 19456
Contact: Nathaniel Marchetti    +001 (610) 630-2222    Nathaniel.marchetti@tuhs.temple.edu   
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Fredric Jaffe    +001 (215) 707-3332    Fredric.Jaffe@tuhs.temple.edu   
United States, South Carolina
AnMed Health Clinical Research Recruiting
Anderson, South Carolina, United States, 29621
Contact: Abhijit Raval    +001 (864) 225-5667    drravallung@gmail.com   
United States, Texas
Metroplex Pul and Sleep Ctr Recruiting
McKinney, Texas, United States, 75069-1769
Contact: Shahrukh Kureishy    +001 (972) 838-1892    shahrukh_kureishy@yahoo.com   
United States, Washington
MultiCare Institute for Research and Innovation Recruiting
Tacoma, Washington, United States, 98405
Contact: Stephen Ryan    +001 (253) 403-0389    scryan@multicare.org   
Sponsors and Collaborators
Boehringer Ingelheim

Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03717012     History of Changes
Other Study ID Numbers: 1199-0324
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
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:// trials.boehringer-ingelheim.com/ 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'.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action