Purpose

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

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Currently taking nintedanib, at a stable dose for 3-30 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, 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

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Trials Today and nearby locations

Moses H. Cone Memorial Hospital
Greensboro, North Carolina 27401
Contact:
Murali Ramaswamy
+001 (336) 323-5276
Murali.ramaswamy@pulmonix.com

University of Cincinnati
Cincinnati, Ohio 45219
Contact:
Nishant Gupta
+001 (513) 558-4831
guptans@ucmail.uc.edu

Weill Cornell Medical College
New York, New York 10065
Contact:
Robert Kaner
+001 (646) 962-2333
rkaner@med.cornell.edu

Icahn School of Medicine at Mount Sinai
New York, New York 10029
Contact:
Maria Padilla
+001 (212) 241-6500
maria.padilla@mssm.edu

St. Vincent Physicians Sleep and Respiratory Center
Billings, Montana 59101
Contact:
Frederick Kahn
+001 (406) 238-6800
Frederick.kahn@sclhs.net

Glacier View Research Institute
Kalispell, Montana 59901
Contact:
Timothy Obermiller
+001 (406) 752-7636
tobermiller@krmc.org

Temple University Hospital
Oaks, Pennsylvania 19456
Contact:
Nathaniel Marchetti
+001 (610) 630-2222
Nathaniel.marchetti@tuhs.temple.edu

Temple University Hospital
Philadelphia, Pennsylvania 19140
Contact:
Fredric Jaffe
+001 (215) 707-3332
Fredric.Jaffe@tuhs.temple.edu

Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington 99204
Contact:
Jiten Patel
+001 (509) 465-3919
Jiten.Patel2@providence.org

MultiCare Institute for Research and Innovation
Tacoma, Washington 98405
Contact:
Stephen Ryan
+001 (253) 403-0389
scryan@multicare.org

University of Utah Health Sciences Center
Salt Lake City, Utah 84108
Contact:
Sean Callahan
+001 (801) 581-7806
sean.callahan@hsc.utah.edu

Metroplex Pul and Sleep Ctr
McKinney, Texas 75069-1769
Contact:
Shahrukh Kureishy
+001 (972) 838-1892
shahrukh_kureishy@yahoo.com

AnMed Health Clinical Research
Anderson, South Carolina 29621
Contact:
Abhijit Raval
+001 (864) 225-5667
drravallung@gmail.com

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Lisa Lancaster
+001 (615) 343-7068
lisa.lancaster@vanderbilt.edu

Mayo Clinic-Rochester
Rochester, Minnesota 55905
Contact:
Teng Moua
+001 (507) 266-2497
Moua.teng@mayo.edu

Minnesota Lung Center
Minneapolis, Minnesota 55407
Contact:
Mitchell Kaye
+001 (952) 567-7400
dr.kaye@mnlungresearch.com

Western Connecticut Medical Group
Danbury, Connecticut 06810
Contact:
Thomas Botta
+001 (203) 739-7070
thomas.botta@wchn.org

Miami VA Healthcare System
Miami, Florida 33125
Contact:
Robert Jackson
+001 (305) 575-3548
rjackson2@med.miami.edu

University of Colorado Denver
Aurora, Colorado 80045
Contact:
Joyce Lee
+001 (303) 724-6109
Joyce.Lee@ucdenver.edu

Stanford University Medical Center
Stanford, California 94305
Contact:
Rishi Raj
+001 (650) 721-5464
rishi.raj@stanford.edu

Loma Linda University Medical Center
Loma Linda, California 92354
Contact:
Niranjan Jeganathan
+001 (909) 558-4489
njeganathan@llu.edu

Cedars-Sinai Medical Center
Los Angeles, California 90048
Contact:
Sara Ghandehari
+001 (310) 423-1838
Sara.Ghandehari@cshs.org

Avanza Medical Research Center
Pensacola, Florida 32503
Contact:
Peter Bercz
+001 (850) 477-7900
p.bercz@avanzaresearch.com

Coastal Pulmonary & Crit Care
Saint Petersburg, Florida 33704
Contact:
Warren Abel
+001 (727) 822-6661
Wabelresearch@gmail.com

Pulmonary and Critical Care Associates of Baltimore
Towson, Maryland 21286
Contact:
Mitchell Schwartz
+001 (410) 494-1662-x2625
Schwartz@pccabresearch.com

University of Michigan Health System
Ann Arbor, Michigan 48109
Contact:
Eric White
+001 (734) 763-5118
docew@med.umich.edu

Universitiy of Maryland Medical Center
Baltimore, Maryland 21201
Contact:
Edward Britt
+001 (410) 328-8141
ebritt@som.umaryland.edu

The LaPorte County Institute for Clinical Research
Michigan City, Indiana 46360
Contact:
Ikeadi Ndukwu
+001 (219) 728-8261
indukwu@yahoo.com

Northwestern University
Chicago, Illinois 60611
Contact:
Jane Dematte D'Amico
+001 (312) 695-1879
j-dematte@northwestern.edu

Suburban Lung Associates, SC
Elk Grove Village, Illinois 60007
Contact:
John Pantano
+001 (847) 981-3660
john.pantano@sublung.com

University of California San Diego
La Jolla, California 92037
Contact:
Gordon Yung
+001 (858) 657-5050
gyung@ucsd.edu

More Details

NCT ID
NCT03717012
Status
Recruiting
Sponsor
Boehringer Ingelheim

Study Contact

Boehringer Ingelheim
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.