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The trial was terminated prematurely due to difficulties with recruitment because of the COVID-19 pandemic.
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The main objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nintedanib treatment alone | Active Comparator |
| |
| Nintedanib with a pulmonary rehabilitation program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib | Drug | stable dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Loma Linda University Medical Center |
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| Label | URL |
|---|---|
| Related Info | View source |
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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:
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This was a randomised, open-label, prospective, Phase IV clinical trial of pulmonary rehabilitation during the first 12 weeks of a 24-week treatment period, compared with no pulmonary rehabilitation, in patients already taking nintedanib for idiopathic pulmonary fibrosis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nintedanib 150 mg | Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2019 | Feb 18, 2021 |
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| Pulmonary rehabilitation program | Other | 12 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 | 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. | 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. | 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. | 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. | 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. | 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%. | 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%. | 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. | 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. | 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
| 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
| Baseline (day 1), week 12 (day 85) and week 24 (day 169). |
| Loma Linda |
| California |
| 92354 |
| United States |
| Western Connecticut Medical Group | Danbury | Connecticut | 06810 | United States |
| Miami VA Healthcare System | Miami | Florida | 33125 | United States |
| Coastal Pulmonary & Crit Care | St. Petersburg | Florida | 33704 | United States |
| The LaPorte County Institute for Clinical Research | Michigan City | Indiana | 46360 | United States |
| Pulmonary and Critical Care Associates of Baltimore | Towson | Maryland | 21286 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| St. Vincent Physicians Sleep and Respiratory Center | Billings | Montana | 59101 | United States |
| Glacier View Research Institute | Kalispell | Montana | 59901 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Pulmonix, LLC | Greensboro | North Carolina | 27403 | United States |
| Temple University Hospital | Oaks | Pennsylvania | 19456 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Metroplex Pul and Sleep Ctr | McKinney | Texas | 75069-1769 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | United States |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | United States |
| Froedtert and The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| FG001 | Nintedanib 150 mg + Pulmonary Rehabilitation | Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nintedanib 150 mg | Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. |
| BG001 | Nintedanib 150 mg + Pulmonary Rehabilitation | Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| 6 minute walk distance (6MWD) test | 6 minute walk distance (6MWD) test at baseline. 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. | Mean | Standard Deviation | meter |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not. Patients with no data available at week 12 were excluded. | Posted | Mean | Standard Deviation | meter | Baseline (day 1) and week 12 (day 85). |
|
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not. Patients with no data available at week 24 were excluded. | Posted | Mean | Standard Deviation | meter | Baseline (day 1) and week 24 (day 169). |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not. Patients with no data available at week 12 or week 24 were excluded from their respective analyses. | Posted | Mean | Standard Deviation | Score on a scale. | Baseline (day 1), week 12 (day 85) and week 24 (day 169). |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not. Patients with no data available at week 12 or week 24 were excluded from their respective analyses. | Posted | Mean | Standard Deviation | Score on a scale. | Baseline (day 1), week 12 (day 85) and week 24 (day 169). |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not. Patients with no data available at week 12 or week 24 were excluded from their respective analyses. | Posted | Mean | Standard Deviation | Score on a scale. | Baseline (day 1), week 12 (day 85) and week 24 (day 169). |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not. Patients with no data available at week 12 or week 24 were excluded from their respective analyses. | Posted | Mean | Standard Deviation | Milliliter (mL) | Baseline (day 1), week 12 (day 85) and week 24 (day 169). |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not. Patients with no data available at week 12 or week 24 were excluded from their respective analyses. | Posted | Mean | Standard Deviation | Percent predicted | Baseline (day 1), week 12 (day 85) and week 24 (day 169). |
| ||||||||||||||||||||||||||||||
| Secondary | 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%. | Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not. Patients with no data available at week 12 or week 24 were excluded from their respective analyses. | Posted | Mean | Standard Deviation | Percent change | Baseline (day 1), week 12 (day 85) and week 24 (day 169). |
| ||||||||||||||||||||||||||||||
| Secondary | 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%. | Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not. Patients with no data available at week 12 or week 24 were excluded from their respective analyses. | Posted | Mean | Standard Deviation | Percent change | Baseline (day 1), week 12 (day 85) and week 24 (day 169). |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not. Patients with no data available at week 12 or week 24 were excluded from their respective analyses. | Posted | Count of Participants | Participants | Baseline (day 1), week 12 (day 85) and week 24 (day 169). |
| |||||||||||||||||||||||||||||||
| Secondary | 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. | Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not. Patients with no data available at week 12 or week 24 were excluded from their respective analyses. | Posted | Count of Participants | Participants | Baseline (day 1), week 12 (day 85) and week 24 (day 169). |
| |||||||||||||||||||||||||||||||
| Secondary | 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
| Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not. Patients with no data available at week 12 or week 24 were excluded from their respective analyses. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (day 1), week 12 (day 85) and week 24 (day 169). |
| ||||||||||||||||||||||||||||||
| Secondary | 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
| Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not. Patients with no data available at week 12 or week 24 were excluded from their respective analyses. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (day 1), week 12 (day 85) and week 24 (day 169). |
|
From first Nintedanib drug intake on/after randomization (or re-start of nintedanib if interruption) to the last Nintedanib drug intake plus 28 days plus one day. Up to 263 days.
Randomized set (RS): This patient set includes all randomized patients, whether treated with pulmonary rehabilitation or not.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nintedanib 150 mg | Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. | 0 | 9 | 3 | 9 | 4 | 9 |
| EG001 | Nintedanib 150 mg + Pulmonary Rehabilitation | Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards. | 1 | 10 | 2 | 10 | 6 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Colitis microscopic | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Mycoplasma infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphocyte percentage decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Mean platelet volume decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Neutrophil percentage increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intervertebral disc compression | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2020 | Feb 18, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C530716 | nintedanib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial.
In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards.
|
|
| OG001 | Nintedanib 150 mg + Pulmonary Rehabilitation | Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards. |
|
|
| OG001 | Nintedanib 150 mg + Pulmonary Rehabilitation | Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards. |
|
|
| OG001 | Nintedanib 150 mg + Pulmonary Rehabilitation | Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards. |
|
|
Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial.
In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards.
|
|
| OG001 | Nintedanib 150 mg + Pulmonary Rehabilitation | Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards. |
|
|
| OG001 |
| Nintedanib 150 mg + Pulmonary Rehabilitation |
Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards. |
|
|
| OG001 | Nintedanib 150 mg + Pulmonary Rehabilitation | Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards. |
|
|
| OG001 | Nintedanib 150 mg + Pulmonary Rehabilitation | Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards. |
|
|
| OG001 | Nintedanib 150 mg + Pulmonary Rehabilitation | Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards. |
|
|
Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards. |
|
|
| Nintedanib 150 mg + Pulmonary Rehabilitation |
Subjects were required to be treated on a stable (up to 30 months) dose of nintedanib 150 milligram (mg) twice a day (BID) administered per prescribing instructions and to continue on this dose throughout the trial. Patients who 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. Patients that have had an interruption in nintedanib treatment or a temporary dose reduction can be entered into the trial when they have returned to a dose of 150 mg BID and their condition is determined to be stable by the investigator and temporary dose reductions to treat adverse events is permitted during the trial. In addition patients received a standard pulmonary rehabilitation regimen two or three times weekly for 12 weeks. The pulmonary rehabilitation should follow the facility's standard regimen as long as the regimen meets basic standards. |
|
|
| Within 5% change |
|
| Increase by >5% |
|
| Within 10% change |
|
| Increase by >10% |
|