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

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ClinicalTrials.gov Identifier: NCT03717012
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : September 17, 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 ...

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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

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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 3-30 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.

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

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Sponsors and Collaborators
Boehringer Ingelheim

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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: September 17, 2019
Last Verified: September 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'.

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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
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action