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

NCT03717012 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 1199-0324
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 19

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)

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the 6 Minute Walk Test (6MWD) at 12 Weeks

  Absolute change from baseline in the 6 minute walk distance (6MWD) test at 12 weeks. The last assessment before treatment period start (included) will be used as baseline. If the baseline value is missing and the screening value is available, then the baseline value will be defined as the screening value taken closest to baseline date.

  Baseline (day 1) and week 12 (day 85).

Secondary Outcomes (12)

• Change From Baseline in the 6 Minute Walk Test (6MWD) at 24 Weeks

  Baseline (day 1) and week 24 (day 169).

• Change From Baseline in the St George's Respiratory Questionnaire (SGRQ) Total Score at 12 and 24 Weeks

  Baseline (day 1), week 12 (day 85) and week 24 (day 169).

• Absolute Change From Baseline in The King's Brief Interstitial Lung Disease (KBILD) Questionnaire Total Score at 12 and 24 Weeks

  Baseline (day 1), week 12 (day 85) and week 24 (day 169).

• Change From Baseline in the University of California, San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Total Score at 12 and 24 Weeks

  Baseline (day 1), week 12 (day 85) and week 24 (day 169).

• Absolute Change From Baseline of Forced Vital Capacity (FVC) at 12 and 24 Weeks

  Baseline (day 1), week 12 (day 85) and week 24 (day 169).

Study Arms (2)

Nintedanib treatment alone

ACTIVE COMPARATOR

Drug: Nintedanib

Nintedanib with a pulmonary rehabilitation program

EXPERIMENTAL

Drug: Nintedanib; Other: Pulmonary rehabilitation program

Interventions

Nintedanib DRUG

stable dose

Nintedanib treatment alone; Nintedanib with a pulmonary rehabilitation program

Pulmonary rehabilitation program OTHER

12 weeks

Nintedanib with a pulmonary rehabilitation program

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (19)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Western Connecticut Medical Group

Danbury, Connecticut, 06810, United States

Location

Miami VA Healthcare System

Miami, Florida, 33125, United States

Location

Coastal Pulmonary & Crit Care

St. Petersburg, Florida, 33704, United States

Location

The LaPorte County Institute for Clinical Research

Michigan City, Indiana, 46360, United States

Location

Pulmonary and Critical Care Associates of Baltimore

Towson, Maryland, 21286, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

St. Vincent Physicians Sleep and Respiratory Center

Billings, Montana, 59101, United States

Location

Glacier View Research Institute

Kalispell, Montana, 59901, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Pulmonix, LLC

Greensboro, North Carolina, 27403, United States

Location

Temple University Hospital

Oaks, Pennsylvania, 19456, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Metroplex Pul and Sleep Ctr

McKinney, Texas, 75069-1769, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States

Location

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Trial was terminated prematurely due to difficulties with recruitment and a global BI recruitment hold implemented on 17 March 2020 because of the COVID-19 pandemic. The recruitment rate was slow and the target number of participants to be recruited was not reached. No inferential statistical analysis was performed.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 23, 2018
• Study Start: November 15, 2018
• Primary Completion: March 27, 2020
• Study Completion: June 10, 2020
• Last Updated: June 9, 2021
• Results First Posted: June 9, 2021

Record last verified: 2021-05

Locations

US (19)