Idiopathic Pulmonary FibrosisPhase 4NCT03717012
Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 4 study testing Nintedanib and Pulmonary rehabilitation program in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 19 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Nintedanib and Pulmonary rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 19 sitesUnited States
- Study dates
- 15 Nov 2018to 10 Jun 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
St. Vincent Physicians Sleep and Respiratory Center
Billings, Montana, 59101
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Virginia Health System
Charlottesville, Virginia, 22903
Baylor University Medical Center
Dallas, Texas, 75246
Western Connecticut Medical Group
Danbury, Connecticut, 06810
Pulmonix, LLC
Greensboro, North Carolina, 27403
Glacier View Research Institute
Kalispell, Montana, 59901
Loma Linda University Medical Center
Loma Linda, California, 92354
Metroplex Pul and Sleep Ctr
McKinney, Texas, 75069-1769
Miami VA Healthcare System
Miami, Florida, 33125
The LaPorte County Institute for Clinical Research
Michigan City, Indiana, 46360
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Temple University Hospital
Oaks, Pennsylvania, 19456
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Coastal Pulmonary & Crit Care
St. Petersburg, Florida, 33704
Pulmonary and Critical Care Associates of Baltimore
Towson, Maryland, 21286
About this study
Official title: Study of Pulmonary Rehabilitation In Nintedanib Treated Patients With IPF: Improvements in Activity, Exercise Endurance Time, and QoL
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
- Being tested
- Nintedanib, Pulmonary rehabilitation program
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
stable dose
Pulmonary rehabilitation programOther
12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Nintedanib treatment alone | Active comparator | Not described Receives: Drug: Nintedanib |
| Nintedanib with a pulmonary rehabilitation program | Experimental | Not described Receives: Drug: Nintedanib; Other: Pulmonary rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (day 1) and week 12 (day 85).
Secondary outcomes (12)
Change From Baseline in the 6 Minute Walk Test (6MWD) at 24 Weeks
Absolute change from baseline in the 6 minute walk distance (6MWD) test at 24 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.
Measured: 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
Absolute change from baseline in the St George's Respiratory Questionnaire (SGRQ) total score at 12 and 24 weeks. The SGRQ is a widely used disease specific questionnaire evaluating health related quality of life. The SGRQ Total Score is measured using patient self-reported question on disease impact on symptoms, patient activity, and daily life. SGRQ scores are calculated using weights attached to each item of the questionnaire which provides an estimate of the distress associated with the symptoms or state described in each item. The total score for SGRQ ranges from 0 to 100, with higher scores indicating more limitations.
Measured: 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
Absolute change from baseline in The King's Brief Interstitial Lung Disease (KBILD) questionnaire total score at 12 and 24 weeks. The KBILD questionnaire is a disease specific questionnaire evaluating health related quality of life. The questionnaire consists of 15 items. Raw total scores were weighted with a Likert response scale to create the total score, total scores were transformed to a range of 0-100 ((actual score-lowest possible score/range)*100), with a score of 100 representing the best health status.
Measured: 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
Change from baseline in the University of California, San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) total score at 12 and 24 weeks. The UCSD-SOBQ is a 24-item questionnaire that assesses self-reported shortness of breath while performing a variety of activities of daily living, scores for each item range from 0 to 5, with higher scores indicating more limitations. Total score is calculated as the sum of all individual scores. Scores range from 0 to 120, with higher scores indicating more limitations.
Measured: 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
Absolute change from baseline of forced vital capacity (FVC) at 12 and 24 weeks. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
Absolute Change From Baseline of Forced Vital Capacity (FVC) % Predicted at 12 and 24 Weeks
Absolute change from baseline of forced vital capacity (FVC) % predicted at 12 and 24 weeks. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. For predicted normal values, different sites may use different prediction formulas, based on the method used to measure diffusing capacity of the lung for carbon monoxide (DLco). In any case, the method used must be in compliance with the European Respiratory Society (ERS)/American Thoracic Society (ATS) guideline on DLco measurements, and the prediction formula appropriate for that method.
Measured: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
Relative Change From Baseline of Forced Vital Capacity (FVC) at 12 and 24 Weeks
Relative change (unitless) from baseline of forced vital capacity (FVC) at 12 and 24 weeks. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC is measured in milliliter (mL). Its relative change from baseline at 12 (24) weeks is calculated as: (FVC measured at 12 (24) weeks - FVC measured at baseline)/ FVC measured at baseline *100%.
Measured: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
Relative Change From Baseline of Forced Vital Capacity (FVC) % Predicted at 12 and 24 Weeks
Relative change (unitless) from baseline of forced vital capacity (FVC) % predicted at 12 and 24 weeks. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. For predicted normal values, different sites may use different prediction formulas, based on the method used to measure diffusing capacity of the lung for carbon monoxide (DLco). In any case, the method used must be in compliance with the European Respiratory Society (ERS)/American Thoracic Society (ATS) guideline on DLco measurements, and the prediction formula appropriate for that method. The relative change from baseline of FVC % predicted at 12 (24) weeks is calculated as: (FVC % Predicted measured at 12 (24) weeks - FVC % Predicted measured at baseline)/ FVC % Predicted measured at baseline *100%.
Measured: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
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%)
Absolute categorical change of forced vital capacity (FVC)% predicted up to 12 and 24 weeks, the following three categories were defined: decrease by >5%, increase by >5%, and change within ≤5%. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. For predicted normal values, different sites may use different prediction formulas, based on the method used to measure diffusing capacity of the lung for carbon monoxide (DLco). In any case, the method used must be in compliance with the European Respiratory Society (ERS)/American Thoracic Society(ATS) guideline on DLco measurements, and the prediction formula appropriate for that method.
Measured: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
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%)
Absolute categorical change of forced vital capacity (FVC)% predicted up to 12 and 24 weeks, the following three categories were defined: decrease by >10%, increase by >10%, and change within ≤10%. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. For predicted normal values, different sites may use different prediction formulas, based on the method used to measure diffusing capacity of the lung for carbon monoxide (DLco). In any case, the method used must be in compliance with the European Respiratory Society (ERS)/American Thoracic Society(ATS) guideline on DLco measurements, and the prediction formula appropriate for that method.
Measured: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
Change From Baseline in Daily Accelerometer Activity From Baseline at 12 and 24 Weeks: Score of Average Steps/Day
Change from baseline in daily accelerometer activity from baseline at 12 and 24 weeks: Score of average Steps/day. Categories were defined as follows:
Steps (total daily value) 0 = 0 to 1900 steps/day
- = 1901 to 3700 steps/day
- = 3701 to 5500 steps/day
- = 5501 to 7300 steps/day
- = >7301 steps/day
Measured: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
Change From Baseline in Daily Accelerometer Activity From Baseline at 12 and 24 Weeks: Score of Average Vector Magnitude Units (VMU)/Day
Change from baseline in daily accelerometer activity from baseline at 12 and 24 weeks: Score of average vector magnitude units (VMU)/day. Categories were defined as follows:
VMU (daily VMU/min) 0 = 0 to 50 VMU/min
- = 51 to 110 VMU/min
- = 111 to 190 VMU/min
- = 191 to 270 VMU/min
- = 271 to 440 VMU/min
- = >441 VMU/min
Measured: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start15 Nov 2018
- Primary completion27 Mar 2020
- Study completion10 Jun 2020
Why it stopped: The trial was terminated prematurely due to difficulties with recruitment because of the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717012
- Sponsor's protocol ID
- 1199-0324
- Status last verified
- May 2021
- First submitted
- 19 Oct 2018
- Last updated
- 9 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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'.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pulmonary Rehabilitation In Nintedanib Treated Patients With IPF: Improvements in Activity, Exercise Endurance Time, and QoL
- ClinicalTrials.gov ID
- NCT03717012
- Acronym / sponsor ID
- 1199-0324
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated prematurely due to difficulties with recruitment because of the COVID-19 pandemic.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 9 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintedanib treatment alone | Active comparator | Drug: Nintedanib |
| Nintedanib with a pulmonary rehabilitation program | Experimental | Drug: Nintedanib, Other: Pulmonary rehabilitation program |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nintedanibstable dose | Drug | Nintedanib treatment alone, Nintedanib with a pulmonary rehabilitation program |
| Pulmonary rehabilitation program12 weeks | Other | Nintedanib with a pulmonary rehabilitation program |
Primary outcome
Change From Baseline in the 6 Minute Walk Test (6MWD) at 12 Weeks
Time frame: Baseline (day 1) and week 12 (day 85).
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.
12 secondary outcomes
Change From Baseline in the 6 Minute Walk Test (6MWD) at 24 Weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
Absolute Change From Baseline of Forced Vital Capacity (FVC) % Predicted at 12 and 24 Weeks
Time frame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
Relative Change From Baseline of Forced Vital Capacity (FVC) at 12 and 24 Weeks
Time frame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
Relative Change From Baseline of Forced Vital Capacity (FVC) % Predicted at 12 and 24 Weeks
Time frame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
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%)
Time frame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
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%)
Time frame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
Change From Baseline in Daily Accelerometer Activity From Baseline at 12 and 24 Weeks: Score of Average Steps/Day
Time frame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
Change From Baseline in Daily Accelerometer Activity From Baseline at 12 and 24 Weeks: Score of Average Vector Magnitude Units (VMU)/Day
Time frame: Baseline (day 1), week 12 (day 85) and week 24 (day 169).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nintedanib and Pulmonary rehabilitation program in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the 6 Minute Walk Test (6MWD) at 12 Weeks (time frame: Baseline (day 1) and week 12 (day 85).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.