Clinical trial NCT03717012: Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Official title: Study of Pulmonary Rehabilitation In Nintedanib Treated Patients With IPF: Improvements in Activity, Exercise Endurance Time, and QoL
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-10-23
Enrollment: 19
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: Inclusion criteria:

* 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.

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
* Previous participation in pulmonary rehabilitation program within 45 days prior to signing consent

Primary outcomes:
measure: Change From Baseline in the 6 Minute Walk Test (6MWD) at 12 Weeks
timeFrame: Baseline (day 1) and week 12 (day 85).
Secondary outcomes:
measure: Change From Baseline in the 6 Minute Walk Test (6MWD) at 24 Weeks
timeFrame: Baseline (day 1) and week 24 (day 169).
measure: Change From Baseline in the St George's Respiratory Questionnaire (SGRQ) Total Score at 12 and 24 Weeks
timeFrame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
measure: Absolute Change From Baseline in The King's Brief Interstitial Lung Disease (KBILD) Questionnaire Total Score at 12 and 24 Weeks
timeFrame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
measure: Change From Baseline in the University of California, San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Total Score at 12 and 24 Weeks
timeFrame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
measure: Absolute Change From Baseline of Forced Vital Capacity (FVC) at 12 and 24 Weeks
timeFrame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
measure: Absolute Change From Baseline of Forced Vital Capacity (FVC) % Predicted at 12 and 24 Weeks
timeFrame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
measure: Relative Change From Baseline of Forced Vital Capacity (FVC) at 12 and 24 Weeks
timeFrame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
measure: Relative Change From Baseline of Forced Vital Capacity (FVC) % Predicted at 12 and 24 Weeks
timeFrame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
measure: Absolute Categorical Change of Forced Vital Capacity (FVC)% Predicted up to 12 and 24 Weeks (Decrease by >5%, Increase by >5%, and Change Within ≤5%)
timeFrame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
measure: Absolute Categorical Change of Forced Vital Capacity (FVC)% Predicted up to 12 and 24 Weeks (Decrease by >10%, Increase by >10%, and Change Within ≤10%)
timeFrame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
measure: Change From Baseline in Daily Accelerometer Activity From Baseline at 12 and 24 Weeks: Score of Average Steps/Day
timeFrame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
measure: Change From Baseline in Daily Accelerometer Activity From Baseline at 12 and 24 Weeks: Score of Average Vector Magnitude Units (VMU)/Day
timeFrame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Danbury
country: United States
facility: Western Connecticut Medical Group
state: Connecticut
city: Miami
country: United States
facility: Miami VA Healthcare System
state: Florida
city: Saint Petersburg
country: United States
facility: Coastal Pulmonary & Crit Care
state: Florida
city: Michigan City
country: United States
facility: The LaPorte County Institute for Clinical Research
state: Indiana
city: Towson
country: United States
facility: Pulmonary and Critical Care Associates of Baltimore
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Billings
country: United States
facility: St. Vincent Physicians Sleep and Respiratory Center
state: Montana
city: Kalispell
country: United States
facility: Glacier View Research Institute
state: Montana
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Greensboro
country: United States
facility: Pulmonix, LLC
state: North Carolina
city: Oaks
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: McKinney
country: United States
facility: Metroplex Pul and Sleep Ctr
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center and Children's Hospital
state: Washington
city: Milwaukee
country: United States
facility: Froedtert and The Medical College of Wisconsin
state: Wisconsin
Study officials:
References: