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

Study 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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03717012
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Milwaukee, Wisconsin

Status

Recruiting

Address

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

Vijaya Ramalingam

vramalingam@mcw.edu

+001 (414) 955-7040

Tacoma, Washington

Status

Recruiting

Address

MultiCare Institute for Research and Innovation

Tacoma, Washington, 98405

Site Contact

Stephen Ryan

scryan@multicare.org

+001 (253) 403-0389

Spokane, Washington

Status

Recruiting

Address

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204

Vermont Lung Center, Burlington, Vermont

Status

Recruiting

Address

Vermont Lung Center

Burlington, Vermont, 05401

Salt Lake City, Utah

Status

Recruiting

Address

University of Utah Health Sciences Center

Salt Lake City, Utah, 84108

Site Contact

Sean Callahan

sean.callahan@hsc.utah.edu

+001 (801) 581-7806

Metroplex Pul and Sleep Ctr, McKinney, Texas

Status

Recruiting

Address

Metroplex Pul and Sleep Ctr

McKinney, Texas, 75069-1769

Site Contact

Shahrukh Kureishy

shahrukh_kureishy@yahoo.com

+001 (972) 838-1892

The University Of Texas at Houston, Houston, Texas

Status

Recruiting

Address

The University Of Texas at Houston

Houston, Texas, 77030

Baylor University Medical Center, Dallas, Texas

Status

Recruiting

Address

Baylor University Medical Center

Dallas, Texas, 75246

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

AnMed Health Clinical Research, Anderson, South Carolina

Status

Recruiting

Address

AnMed Health Clinical Research

Anderson, South Carolina, 29621

Site Contact

Abhijit Raval

drravallung@gmail.com

+001 (864) 225-5667

Temple University Hospital, Philadelphia, Pennsylvania

Status

Recruiting

Address

Temple University Hospital

Philadelphia, Pennsylvania, 19140

Temple University Hospital, Oaks, Pennsylvania

Status

Recruiting

Address

Temple University Hospital

Oaks, Pennsylvania, 19456

Site Contact

Nathaniel Marchetti

Nathaniel.marchetti@tuhs.temple.edu

+001 (610) 630-2222

University of Cincinnati, Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati

Cincinnati, Ohio, 45219

Site Contact

Nishant Gupta

guptans@ucmail.uc.edu

+001 (513) 558-4831

Moses H. Cone Memorial Hospital, Greensboro, North Carolina

Status

Recruiting

Address

Moses H. Cone Memorial Hospital

Greensboro, North Carolina, 27401

Site Contact

Murali Ramaswamy

Murali.ramaswamy@pulmonix.com

+001 (336) 522-8870

Chapel Hill, North Carolina

Status

Recruiting

Address

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27517

Site Contact

Leonard Lobo

Jason_lobo@med.unc.edu

+001 (919) 966-2531

Weill Cornell Medical College, New York, New York

Status

Recruiting

Address

Weill Cornell Medical College

New York, New York, 10065

Site Contact

Robert Kaner

rkaner@med.cornell.edu

+001 (646) 962-2333

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

Maria Padilla

maria.padilla@mssm.edu

+001 (212) 241-6500

Glacier View Research Institute, Kalispell, Montana

Status

Recruiting

Address

Glacier View Research Institute

Kalispell, Montana, 59901

Site Contact

Timothy Obermiller

tobermiller@krmc.org

+001 (406) 752-7636

Billings, Montana

Status

Recruiting

Address

St. Vincent Physicians Sleep and Respiratory Center

Billings, Montana, 59101

Site Contact

Frederick Kahn

Frederick.kahn@sclhs.net

+001 (406) 238-6800

Mayo Clinic, Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic, Rochester

Rochester, Minnesota, 55905

Site Contact

Teng Moua

Moua.teng@mayo.edu

+001 (507) 266-2497

Minnesota Lung Center, Minneapolis, Minnesota

Status

Recruiting

Address

Minnesota Lung Center

Minneapolis, Minnesota, 55407

Site Contact

Mitchell Kaye

dr.kaye@mnlungresearch.com

+001 (612) 863-3750

University of Michigan Health System, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan Health System

Ann Arbor, Michigan, 48109

Site Contact

Eric White

docew@med.umich.edu

+001 (734) 763-5118

Towson, Maryland

Status

Recruiting

Address

Pulmonary and Critical Care Associates of Baltimore

Towson, Maryland, 21286

Site Contact

Mitchell Schwartz

Schwartz@pccabresearch.com

+001 (410) 494-1662-x2625

Universitiy of Maryland Medical Center, Baltimore, Maryland

Status

Recruiting

Address

Universitiy of Maryland Medical Center

Baltimore, Maryland, 21201

Site Contact

Edward Britt

ebritt@som.umaryland.edu

+001 (410) 328-8141

Michigan City, Indiana

Status

Recruiting

Address

The LaPorte County Institute for Clinical Research

Michigan City, Indiana, 46360

Site Contact

Ikeadi Ndukwu

indukwu@yahoo.com

+001 (219) 728-8261

Springfield, Illinois

Status

Recruiting

Address

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

Site Contact

Rajagopal Sreedhar

rsreedhar@siumed.edu

+001 (618) 632-3006

Loyola University Medical Center, Maywood, Illinois

Status

Recruiting

Address

Loyola University Medical Center

Maywood, Illinois, 60153

Site Contact

Daniel Dilling

ddillin@LUMC.edu

+001 (708) 216 5744

Suburban Lung Associates, SC, Elk Grove Village, Illinois

Status

Recruiting

Address

Suburban Lung Associates, SC

Elk Grove Village, Illinois, 60007

Site Contact

John Pantano

john.pantano@sublung.com

+001 (847) 981-3660

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Site Contact

Jane Dematte D'Amico

j-dematte@northwestern.edu

+001 (312) 695-1879

Coastal Pulmonary & Crit Care, Saint Petersburg, Florida

Status

Recruiting

Address

Coastal Pulmonary & Crit Care

Saint Petersburg, Florida, 33704

Site Contact

Warren Abel

Wabelresearch@gmail.com

+001 (727) 822-6661

Avanza Medical Research Center, Pensacola, Florida

Status

Recruiting

Address

Avanza Medical Research Center

Pensacola, Florida, 32503

Miami VA Healthcare System, Miami, Florida

Status

Recruiting

Address

Miami VA Healthcare System

Miami, Florida, 33125

Site Contact

Robert Jackson

rjackson2@med.miami.edu

+001 (305) 575-3548

Western Connecticut Medical Group, Danbury, Connecticut

Status

Recruiting

Address

Western Connecticut Medical Group

Danbury, Connecticut, 06810

Site Contact

Thomas Botta

thomas.botta@wchn.org

+001 (203) 739-7070

University of Colorado Denver, Aurora, Colorado

Status

Recruiting

Address

University of Colorado Denver

Aurora, Colorado, 80045

Stanford University Medical Center, Stanford, California

Status

Recruiting

Address

Stanford University Medical Center

Stanford, California, 94305

Cedars-Sinai Medical Center, Los Angeles, California

Status

Recruiting

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Site Contact

Sara Ghandehari

Sara.Ghandehari@cshs.org

+001 (310) 423-1838

Loma Linda University Medical Center, Loma Linda, California

Status

Recruiting

Address

Loma Linda University Medical Center

Loma Linda, California, 92354

Site Contact

Niranjan Jeganathan

njeganathan@llu.edu

+001 (909) 558-4489

University of California San Diego, La Jolla, California

Status

Recruiting

Address

University of California San Diego

La Jolla, California, 92037

Site Contact

Gordon Yung

gyung@ucsd.edu

+001 (858) 657-5050

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Site Contact

Tejaswini Kulkarni

tkulkarni@uabmc.edu

+001 (205) 975-6770

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The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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