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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024252-29 | EudraCT Number | EudraCT |
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Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.
In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.
Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.
Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | patient receives capsules identical to those containing active drug |
|
| BIBF 1120 | Experimental | patient receives capsules containing BIBF 1120 twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | placebo matching BIBF 1120 BID |
| |
| BIBF 1120 |
| Measure | Description | Time Frame |
|---|---|---|
| Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks. | Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks | This is a key secondary endpoint. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status. Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52). |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1199.34.10078 Boehringer Ingelheim Investigational Site | Scottsdale | Arizona | United States | |||
| 1199.34.10086 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33902584 | Derived | Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y. | |
| 33239000 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Oral administration of Placebo matching nintedanib soft gelatine capsules |
| FG001 | Nintedanib 150 mg Bid | Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid). Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
BIBF 1120 BID (twice daily) |
|
| Baseline and 52 weeks |
| Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation | Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. An acute exacerbation (reported as an AE by the investigator) was defined as follows: Otherwise unexplained clinical features including all of the following: Unexplained worsening or development of dyspnoea within 30 days New diffuse pulmonary infiltrates on chest X-ray, and/or new HRCT parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit Exclusion of infection as per routine clinical practice and microbiological studies Exclusion of alternative causes as per routine clinical practice including left heart failure, pulmonary embolism and identifiable cause of acute lung injury. Failure is the proportion of patients with at least one acute IPF exacerbation over 52 weeks, based on all investigator-reported AEs . | 52 weeks |
| Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks | Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). | Baseline and 52 weeks |
| Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks | Percentage change from baseline in FVC over 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). | Baseline and 52 weeks |
| Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks | Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). | Baseline and 52 weeks |
| Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks | Percentage change from baseline in FVC (% predicted) at 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). | Baseline and 52 weeks |
| Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold | Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%). | Baseline and 52 weeks |
| Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold | Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%) | Baseline and 52 weeks |
| FVC Responders Using 10% Threshold at 52 Weeks | FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks. | 52 weeks |
| Proportion of FVC Responders Using 5% Threshold at 52 Weeks | Proportion of FVC responders using 5% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 5% and with an FVC evaluation at 52 weeks. | 52 weeks |
| Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs) | Proportion of SGRQ responders at 52 weeks. Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks. | baseline and 52 weeks |
| Change From Baseline in SGRQ Symptom Score at 52 Weeks (Points): Patient Reported Outcomes (PROs) | SGRQ Symptom score is a sub-component of SGRQ total score and is concerned with the effect of respiratory symptoms, their frequency and severity. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better symptom-related quality of life. Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52). | baseline and 52 weeks |
| Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs) | SGRQ Impact score is a sub-component of SGRQ total score and covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better impact-related quality of life. Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52). | baseline and 52 weeks |
| Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs) | SGRQ Activity score is a sub-component of SGRQ total score and concerned with activities that cause or are limited by breathlessness. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better activity-related quality of life. Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52). | baseline and 52 weeks |
| Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs) | SGRQ-I is the IPF specific version of SGRQ comprises of selected items from the SGRQ divided into three components, Symptoms, Activity and Impact. Each component is scored separately. The weights for all items with a positive responses are summed and the weights from missed items are deducted from the maximum possible weight for the total score. The total score is calculated by dividing the summed weights from positive items in the questionnaire by maximum possible weight for all items in the questionnaire. The total score can range from 0 to 100 with a lower score denoting a better health-related quality of life. Change from baseline is calculated as the difference between total score at week 52 and total score at baseline as measured by the scale. | baseline and 52 weeks |
| Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs) | Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome). Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52). | baseline and 52 weeks |
| Change From Baseline in Cough Symptom Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs) | The cough domains of the Cough and Sputum Assessment Questionnaire (CASAQ(CD)) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome). Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52). | baseline and 52 weeks |
| Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs) | The cough domains of the Cough and Sputum Assessment Questionnaire (CASA- Q) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome). Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52). | baseline and 52 weeks |
| Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs) | Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'. | 52 weeks |
| Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs) | The EuroQol 5-dimensional Health State is based on a visual analog scale (EQ-VAS) representing the general patient's health state labelled from 100 (best imaginable health state) to 0 (worst imaginable health state). A higher score indicating a better health state. Change from baseline is calculated as the difference between health state at week 12, 24 and 52 respectively and health state at baseline as measured by the scale. | baseline, 12 weeks, 24 weeks and 52 weeks |
| Risk of an Acute IPF Exacerbation Over 52 Weeks | The incidence rate of exacerbations (calculated as the number of patients with at least 1 acute IPF exacerbation divided by the total number of years at risk in years*100) | 52 weeks |
| Time to Death Over 52 Weeks | Due to rare events, the median of time to event is not calculable, thus the percentages of patients who did or did not experienced death before or at 372 days after randomisation or last contact date (whichever occurs first) are reported. Failure is the proportion of patients who died over 52 weeks (373 days time-period). | 52 weeks |
| Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated) | Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death due to respiratory causes before or at 372 days after randomisation or last contact date (whichever occurs first) are reported. Failure is the the proportion of patients who died due to respiratory causes over 52 weeks (373 days time-period). | 52 weeks |
| Time to On-treatment Death | Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not die before or at last trial medication intake + 28 days were censored at last trial medication intake + 28 days and reported. Failure is the the proportion of patients who died on-treatment. | 52 weeks |
| Time to Death or Lung Transplant Over 52 Weeks | Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experience event (death or lung transplant) before or at 372 days after randomisation or last contact date (whichever occurs first) are reported. Failure is the proportion of patients who died or had lung transplant over 52 weeks (373 days time-period). | 52 weeks |
| Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks. | Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death or lung transplant or qualifying for lung transplant over 52 weeks are reported. A patient was considered qualifying for lung transplant by the investigator if he or she fulfilled the following criteria: FVC <45% predicted or Carbon monoxide diffusion capacity (DL(CO)) <30% pred or Oxygen saturation on pulse oximetry (SpO2) <88% at rest, at sea level (to be adapted for other heights). These criteria were evaluated by investigators judgement. Failure is the proportion of patients who died or had lung transplant or qualified for lung transplant over 52 weeks (373 days time-period). | 52 weeks |
| Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks | Means presented are the adjusted means. Adjusted mean is based on all analyzed patients in the model (not only patients with a change from baseline to week 52) | baseline and 52 weeks |
| Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks | Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). | baseline and 52 weeks |
| San Francisco |
| California |
| United States |
| 1199.34.10093 Boehringer Ingelheim Investigational Site | Santa Barbara | California | United States |
| 1199.34.10077 Boehringer Ingelheim Investigational Site | Stanford | California | United States |
| 1199.34.10083 Boehringer Ingelheim Investigational Site | Torrance | California | United States |
| 1199.34.10080 Boehringer Ingelheim Investigational Site | Stamford | Connecticut | United States |
| 1199.34.10087 Boehringer Ingelheim Investigational Site | South Miami | Florida | United States |
| 1199.34.10100 Boehringer Ingelheim Investigational Site | Austell | Georgia | United States |
| 1199.34.10075 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| 1199.34.10069 Boehringer Ingelheim Investigational Site | Olathe | Kansas | United States |
| 1199.34.10090 Boehringer Ingelheim Investigational Site | Lexington | Kentucky | United States |
| 1199.34.10079 Boehringer Ingelheim Investigational Site | Rochester | Minnesota | United States |
| 1199.34.10067 Boehringer Ingelheim Investigational Site | Chesterfield | Missouri | United States |
| 1199.34.10066 Boehringer Ingelheim Investigational Site | Lebanon | New Hampshire | United States |
| 1199.34.10085 Boehringer Ingelheim Investigational Site | Albany | New York | United States |
| 1199.34.10092 Boehringer Ingelheim Investigational Site | Jamaica | New York | United States |
| 1199.34.10074 Boehringer Ingelheim Investigational Site | Durham | North Carolina | United States |
| 1199.34.10088 Boehringer Ingelheim Investigational Site | Toledo | Ohio | United States |
| 1199.34.10070 Boehringer Ingelheim Investigational Site | Portland | Oregon | United States |
| 1199.34.10064 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States |
| 1199.34.10089 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States |
| 1199.34.10082 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States |
| 1199.34.10095 Boehringer Ingelheim Investigational Site | Longview | Texas | United States |
| 1199.34.10060 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States |
| 1199.34.10084 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | United States |
| 1199.34.10101 Boehringer Ingelheim Investigational Site | Colchester | Vermont | United States |
| 1199.34.10073 Boehringer Ingelheim Investigational Site | Madison | Wisconsin | United States |
| 1199.34.02001 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada |
| 1199.34.02003 Boehringer Ingelheim Investigational Site | Halifax | Nova Scotia | Canada |
| 1199.34.02002 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| 1199.34.56001 Boehringer Ingelheim Investigational Site | Santiago | Chile |
| 1199.34.86056 Boehringer Ingelheim Investigational Site | Beijing | China |
| 1199.34.86052 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1199.34.86054 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1199.34.86055 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1199.34.86058 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1199.34.86051 Boehringer Ingelheim Investigational Site | Shenyang | China |
| 1199.34.86053 Boehringer Ingelheim Investigational Site | Shenyang | China |
| 1199.34.86057 Boehringer Ingelheim Investigational Site | Yinchuan | China |
| 1199.34.35801 Boehringer Ingelheim Investigational Site | Helsinki | Finland |
| 1199.34.33004 Boehringer Ingelheim Investigational Site | Dijon | France |
| 1199.34.33003 Boehringer Ingelheim Investigational Site | Lille | France |
| 1199.34.33005 Boehringer Ingelheim Investigational Site | Lyon | France |
| 1199.34.33007 Boehringer Ingelheim Investigational Site | Marseille | France |
| 1199.34.33002 Boehringer Ingelheim Investigational Site | Montpellier | France |
| 1199.34.33006 Boehringer Ingelheim Investigational Site | Toulouse | France |
| 1199.34.49003 Boehringer Ingelheim Investigational Site | Bad Berka | Germany |
| 1199.34.49002 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1199.34.49010 Boehringer Ingelheim Investigational Site | Buch | Germany |
| 1199.34.49011 Boehringer Ingelheim Investigational Site | Cologne | Germany |
| 1199.34.49005 Boehringer Ingelheim Investigational Site | Coswig | Germany |
| 1199.34.49001 Boehringer Ingelheim Investigational Site | Essen | Germany |
| 1199.34.49007 Boehringer Ingelheim Investigational Site | Greifswald | Germany |
| 1199.34.49009 Boehringer Ingelheim Investigational Site | Immenhausen | Germany |
| 1199.34.49006 Boehringer Ingelheim Investigational Site | München | Germany |
| 1199.34.49004 Boehringer Ingelheim Investigational Site | Münster | Germany |
| 1199.34.30005 Boehringer Ingelheim Investigational Site | Athens | Greece |
| 1199.34.30001 Boehringer Ingelheim Investigational Site | Heraklion | Greece |
| 1199.34.30004 Boehringer Ingelheim Investigational Site | Larissa | Greece |
| 1199.34.30002 Boehringer Ingelheim Investigational Site | Maroussi, Athens | Greece |
| 1199.34.30003 Boehringer Ingelheim Investigational Site | Nikaia | Greece |
| 1199.34.91051 Boehringer Ingelheim Investigational Site | Ahmedabad | India |
| 1199.34.91053 Boehringer Ingelheim Investigational Site | Banglore | India |
| 1199.34.91056 Boehringer Ingelheim Investigational Site | Jaipur | India |
| 1199.34.91054 Boehringer Ingelheim Investigational Site | Pune | India |
| 1199.34.91055 Boehringer Ingelheim Investigational Site | Pune | India |
| 1199.34.81059 Boehringer Ingelheim Investigational Site | Himeji, Hyogo | Japan |
| 1199.34.81063 Boehringer Ingelheim Investigational Site | Kawasaki, Kanagawa | Japan |
| 1199.34.81060 Boehringer Ingelheim Investigational Site | Kobe, Hyogo | Japan |
| 1199.34.81051 Boehringer Ingelheim Investigational Site | Minato-ku, Tokyo | Japan |
| 1199.34.81054 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 1199.34.81055 Boehringer Ingelheim Investigational Site | Ogaki, Gifu | Japan |
| 1199.34.81058 Boehringer Ingelheim Investigational Site | Osaka-Sayama, Osaka | Japan |
| 1199.34.81057 Boehringer Ingelheim Investigational Site | Sakai, Osaka | Japan |
| 1199.34.81053 Boehringer Ingelheim Investigational Site | Seto, Aichi | Japan |
| 1199.34.81052 Boehringer Ingelheim Investigational Site | Shinjuku-ku, Tokyo | Japan |
| 1199.34.81056 Boehringer Ingelheim Investigational Site | Tenri, Nara | Japan |
| 1199.34.81062 Boehringer Ingelheim Investigational Site | Tokushima, Tokushima | Japan |
| 1199.34.81061 Boehringer Ingelheim Investigational Site | Yonago, Tottori | Japan |
| 1199.34.52001 Boehringer Ingelheim Investigational Site | Mexico City | Mexico |
| 1199.34.31002 Boehringer Ingelheim Investigational Site | Amsterdam | Netherlands |
| 1199.34.31001 Boehringer Ingelheim Investigational Site | Nieuwegein | Netherlands |
| 1199.34.31003 Boehringer Ingelheim Investigational Site | Rotterdam | Netherlands |
| 1199.34.35107 Boehringer Ingelheim Investigational Site | Amadora | Portugal |
| 1199.34.35105 Boehringer Ingelheim Investigational Site | Coimbra | Portugal |
| 1199.34.35102 Boehringer Ingelheim Investigational Site | Lisbon | Portugal |
| 1199.34.35103 Boehringer Ingelheim Investigational Site | Lisbon | Portugal |
| 1199.34.35101 Boehringer Ingelheim Investigational Site | Porto | Portugal |
| 1199.34.35106 Boehringer Ingelheim Investigational Site | Vila Nova de Gaia | Portugal |
| 1199.34.07001 Boehringer Ingelheim Investigational Site | Kazan' | Russia |
| 1199.34.07003 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 1199.34.82002 Boehringer Ingelheim Investigational Site | Bucheon-si | South Korea |
| 1199.34.82004 Boehringer Ingelheim Investigational Site | Incheon | South Korea |
| 1199.34.82001 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1199.34.82003 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1199.34.82006 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1199.34.82007 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1199.34.34001 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1199.34.34003 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1199.34.34004 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1199.34.34005 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat | Spain |
| 1199.34.34009 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1199.34.34008 Boehringer Ingelheim Investigational Site | Seville | Spain |
| 1199.34.90003 Boehringer Ingelheim Investigational Site | Ankara | Turkey (Türkiye) |
| 1199.34.90001 Boehringer Ingelheim Investigational Site | Istanbul | Turkey (Türkiye) |
| 1199.34.90005 Boehringer Ingelheim Investigational Site | Istanbul | Turkey (Türkiye) |
| 1199.34.90002 Boehringer Ingelheim Investigational Site | Izmir | Turkey (Türkiye) |
| 1199.34.90004 Boehringer Ingelheim Investigational Site | Izmir | Turkey (Türkiye) |
| Jouneau S, Crestani B, Thibault R, Lederlin M, Vernhet L, Valenzuela C, Wijsenbeek M, Kreuter M, Stansen W, Quaresma M, Cottin V. Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis. Respir Res. 2020 Nov 25;21(1):312. doi: 10.1186/s12931-020-01528-4. |
| 32217654 | Derived | Brown KK, Martinez FJ, Walsh SLF, Thannickal VJ, Prasse A, Schlenker-Herceg R, Goeldner RG, Clerisme-Beaty E, Tetzlaff K, Cottin V, Wells AU. The natural history of progressive fibrosing interstitial lung diseases. Eur Respir J. 2020 Jun 25;55(6):2000085. doi: 10.1183/13993003.00085-2020. Print 2020 Jun. |
| 31914963 | Derived | Richeldi L, Kolb M, Jouneau S, Wuyts WA, Schinzel B, Stowasser S, Quaresma M, Raghu G. Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis. BMC Pulm Med. 2020 Jan 8;20(1):3. doi: 10.1186/s12890-019-1030-4. |
| 30971229 | Derived | Kreuter M, Koegler H, Trampisch M, Geier S, Richeldi L. Differing severities of acute exacerbations of idiopathic pulmonary fibrosis (IPF): insights from the INPULSIS(R) trials. Respir Res. 2019 Apr 11;20(1):71. doi: 10.1186/s12931-019-1037-7. |
| 30729456 | Derived | Xu Z, Li H, Wen F, Bai C, Chen P, Fan F, Hu N, Stowasser S, Kang J. Subgroup Analysis for Chinese Patients Included in the INPULSIS(R) Trials on Nintedanib in Idiopathic Pulmonary Fibrosis. Adv Ther. 2019 Mar;36(3):621-631. doi: 10.1007/s12325-019-0887-1. Epub 2019 Feb 7. |
| 30176872 | Derived | Costabel U, Behr J, Crestani B, Stansen W, Schlenker-Herceg R, Stowasser S, Raghu G. Anti-acid therapy in idiopathic pulmonary fibrosis: insights from the INPULSIS(R) trials. Respir Res. 2018 Sep 3;19(1):167. doi: 10.1186/s12931-018-0866-0. |
| 28526798 | Derived | Collard HR, Richeldi L, Kim DS, Taniguchi H, Tschoepe I, Luisetti M, Roman J, Tino G, Schlenker-Herceg R, Hallmann C, du Bois RM. Acute exacerbations in the INPULSIS trials of nintedanib in idiopathic pulmonary fibrosis. Eur Respir J. 2017 May 19;49(5):1601339. doi: 10.1183/13993003.01339-2016. Print 2017 May. |
| 28388260 | Derived | Paterniti MO, Bi Y, Rekic D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC. |
| 28039616 | Derived | Rinciog C, Watkins M, Chang S, Maher TM, LeReun C, Esser D, Diamantopoulos A. A Cost-Effectiveness Analysis of Nintedanib in Idiopathic Pulmonary Fibrosis in the UK. Pharmacoeconomics. 2017 Apr;35(4):479-491. doi: 10.1007/s40273-016-0480-2. |
| 27672117 | Derived | Kolb M, Richeldi L, Behr J, Maher TM, Tang W, Stowasser S, Hallmann C, du Bois RM. Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume. Thorax. 2017 Apr;72(4):340-346. doi: 10.1136/thoraxjnl-2016-208710. Epub 2016 Sep 26. |
| 26400368 | Derived | Corte T, Bonella F, Crestani B, Demedts MG, Richeldi L, Coeck C, Pelling K, Quaresma M, Lasky JA. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res. 2015 Sep 24;16:116. doi: 10.1186/s12931-015-0276-5. |
| 24836310 | Derived | Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR; INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82. doi: 10.1056/NEJMoa1402584. Epub 2014 May 18. |
| 24834811 | Derived | Richeldi L, Cottin V, Flaherty KR, Kolb M, Inoue Y, Raghu G, Taniguchi H, Hansell DM, Nicholson AG, Le Maulf F, Stowasser S, Collard HR. Design of the INPULSIS trials: two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis. Respir Med. 2014 Jul;108(7):1023-30. doi: 10.1016/j.rmed.2014.04.011. Epub 2014 Apr 29. |
| COMPLETED |
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| NOT COMPLETED |
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Treated Set (TS): The TS consisted of randomized patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Oral administration of Placebo matching nintedanib soft gelatine capsules |
| BG001 | Nintedanib 150 mg Bid | Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid). Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events. |
| 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 |
|
| 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 | Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks. | Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate. | Treated Set | Posted | Mean | Standard Error | mL/year | 52 weeks |
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| Secondary | Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks | This is a key secondary endpoint. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status. Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52). | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Error | points on a scale | Baseline and 52 weeks |
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| Secondary | Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation | Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. An acute exacerbation (reported as an AE by the investigator) was defined as follows: Otherwise unexplained clinical features including all of the following: Unexplained worsening or development of dyspnoea within 30 days New diffuse pulmonary infiltrates on chest X-ray, and/or new HRCT parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit Exclusion of infection as per routine clinical practice and microbiological studies Exclusion of alternative causes as per routine clinical practice including left heart failure, pulmonary embolism and identifiable cause of acute lung injury. Failure is the proportion of patients with at least one acute IPF exacerbation over 52 weeks, based on all investigator-reported AEs . | Treated Set | Posted | Number | percentage of participants | 52 weeks |
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| Secondary | Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks | Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Error | mL | Baseline and 52 weeks |
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| Secondary | Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks | Percentage change from baseline in FVC over 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Error | percent change | Baseline and 52 weeks |
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| Secondary | Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks | Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Error | %predicted | Baseline and 52 weeks |
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| Secondary | Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks | Percentage change from baseline in FVC (% predicted) at 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Error | percent change | Baseline and 52 weeks |
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| Secondary | Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold | Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%). | Treated Set (for patients with change from baseline in FVC (% predicted) at Week 52) | Posted | Number | percentage of participants | Baseline and 52 weeks |
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| Secondary | Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold | Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%) | Treated Set (for patients with change from baseline in FVC (% predicted) at Week 52) | Posted | Number | percentage of participants | Baseline and 52 weeks |
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| Secondary | FVC Responders Using 10% Threshold at 52 Weeks | FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks. | Treated Set | Posted | Number | 95% Confidence Interval | percentage of participants | 52 weeks |
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| Secondary | Proportion of FVC Responders Using 5% Threshold at 52 Weeks | Proportion of FVC responders using 5% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 5% and with an FVC evaluation at 52 weeks. | Treated Set | Posted | Number | 95% Confidence Interval | percentage of participants | 52 weeks |
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| Secondary | Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs) | Proportion of SGRQ responders at 52 weeks. Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks. | Treated Set | Posted | Number | 95% Confidence Interval | percentage of participants | baseline and 52 weeks |
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| Secondary | Change From Baseline in SGRQ Symptom Score at 52 Weeks (Points): Patient Reported Outcomes (PROs) | SGRQ Symptom score is a sub-component of SGRQ total score and is concerned with the effect of respiratory symptoms, their frequency and severity. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better symptom-related quality of life. Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52). | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Error | points on a scale | baseline and 52 weeks |
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| Secondary | Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs) | SGRQ Impact score is a sub-component of SGRQ total score and covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better impact-related quality of life. Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52). | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Error | points on a scale | baseline and 52 weeks |
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| Secondary | Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs) | SGRQ Activity score is a sub-component of SGRQ total score and concerned with activities that cause or are limited by breathlessness. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better activity-related quality of life. Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52). | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Error | points on a scale | baseline and 52 weeks |
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| Secondary | Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs) | SGRQ-I is the IPF specific version of SGRQ comprises of selected items from the SGRQ divided into three components, Symptoms, Activity and Impact. Each component is scored separately. The weights for all items with a positive responses are summed and the weights from missed items are deducted from the maximum possible weight for the total score. The total score is calculated by dividing the summed weights from positive items in the questionnaire by maximum possible weight for all items in the questionnaire. The total score can range from 0 to 100 with a lower score denoting a better health-related quality of life. Change from baseline is calculated as the difference between total score at week 52 and total score at baseline as measured by the scale. | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Error | points on a scale | baseline and 52 weeks |
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| Secondary | Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs) | Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome). Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52). | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Error | points on a scale | baseline and 52 weeks |
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| Secondary | Change From Baseline in Cough Symptom Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs) | The cough domains of the Cough and Sputum Assessment Questionnaire (CASAQ(CD)) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome). Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52). | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Error | points on a scale | baseline and 52 weeks |
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| Secondary | Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs) | The cough domains of the Cough and Sputum Assessment Questionnaire (CASA- Q) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome). Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52). | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Error | points on a scale | baseline and 52 weeks |
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| Secondary | Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs) | Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'. | Treated Set | Posted | Number | 95% Confidence Interval | percentage of participants | 52 weeks |
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| Secondary | Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs) | The EuroQol 5-dimensional Health State is based on a visual analog scale (EQ-VAS) representing the general patient's health state labelled from 100 (best imaginable health state) to 0 (worst imaginable health state). A higher score indicating a better health state. Change from baseline is calculated as the difference between health state at week 12, 24 and 52 respectively and health state at baseline as measured by the scale. | Treated Set | Posted | Mean | Standard Deviation | points on a scale | baseline, 12 weeks, 24 weeks and 52 weeks |
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| Secondary | Risk of an Acute IPF Exacerbation Over 52 Weeks | The incidence rate of exacerbations (calculated as the number of patients with at least 1 acute IPF exacerbation divided by the total number of years at risk in years*100) | Treated Set | Posted | Number | Participants/Year *100 | 52 weeks |
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| Secondary | Time to Death Over 52 Weeks | Due to rare events, the median of time to event is not calculable, thus the percentages of patients who did or did not experienced death before or at 372 days after randomisation or last contact date (whichever occurs first) are reported. Failure is the proportion of patients who died over 52 weeks (373 days time-period). | Treated Set | Posted | Number | percentage of participants | 52 weeks |
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| Secondary | Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated) | Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death due to respiratory causes before or at 372 days after randomisation or last contact date (whichever occurs first) are reported. Failure is the the proportion of patients who died due to respiratory causes over 52 weeks (373 days time-period). | Treated Set | Posted | Number | percentage of participants | 52 weeks |
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| Secondary | Time to On-treatment Death | Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not die before or at last trial medication intake + 28 days were censored at last trial medication intake + 28 days and reported. Failure is the the proportion of patients who died on-treatment. | Treated Set | Posted | Number | percentage of participants | 52 weeks |
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| Secondary | Time to Death or Lung Transplant Over 52 Weeks | Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experience event (death or lung transplant) before or at 372 days after randomisation or last contact date (whichever occurs first) are reported. Failure is the proportion of patients who died or had lung transplant over 52 weeks (373 days time-period). | Treated Set | Posted | Number | percentage of participants | 52 weeks |
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| Secondary | Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks. | Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death or lung transplant or qualifying for lung transplant over 52 weeks are reported. A patient was considered qualifying for lung transplant by the investigator if he or she fulfilled the following criteria: FVC <45% predicted or Carbon monoxide diffusion capacity (DL(CO)) <30% pred or Oxygen saturation on pulse oximetry (SpO2) <88% at rest, at sea level (to be adapted for other heights). These criteria were evaluated by investigators judgement. Failure is the proportion of patients who died or had lung transplant or qualified for lung transplant over 52 weeks (373 days time-period). | Treated Set | Posted | Number | percentage of participants | 52 weeks |
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| Secondary | Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks | Means presented are the adjusted means. Adjusted mean is based on all analyzed patients in the model (not only patients with a change from baseline to week 52) | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Error | percent of oxygen saturation | baseline and 52 weeks |
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| Secondary | Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks | Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52). | Treated Set (Only patients with observed cases (OC) values were analysed) | Posted | Mean | Standard Error | mmol/min/kPa | baseline and 52 weeks |
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From the first drug administration until 28 days after the last drug administration, up to 425 days
Not provided
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 | Placebo | Oral administration of Placebo matching nintedanib soft gelatine capsules. | 72 | 219 | 193 | 219 | ||
| EG001 | Nintedanib 150mg Bid | Oral administration of soft gelatine capsules of Nintedanib 150 mg twice daily (bid). Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events. | 98 | 329 | 308 | 329 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 16.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | 16.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Ventricular dysfunction | Cardiac disorders | 16.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | 16.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | 16.1 | Systematic Assessment |
| |
| Orbital apex syndrome | Eye disorders | 16.1 | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | 16.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | 16.1 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 16.1 | Systematic Assessment |
| |
| Chest pain | General disorders | 16.1 | Systematic Assessment |
| |
| Disease progression | General disorders | 16.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | 16.1 | Systematic Assessment |
| |
| Sudden death | General disorders | 16.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | 16.1 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | 16.1 | Systematic Assessment |
| |
| Non-alcoholic steatohepatitis | Hepatobiliary disorders | 16.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Herpes simplex meningoencephalitis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Infective aneurysm | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Mycobacterial infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Pathogen resistance | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Burns third degree | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | 16.1 | Systematic Assessment |
| |
| Arteriogram coronary | Investigations | 16.1 | Systematic Assessment |
| |
| Chest X-ray abnormal | Investigations | 16.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Chloroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Neurofibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Piriformis syndrome | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 16.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | 16.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | 16.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | 16.1 | Systematic Assessment |
| |
| Coronary angioplasty | Surgical and medical procedures | 16.1 | Systematic Assessment |
| |
| Lung transplant | Surgical and medical procedures | 16.1 | Systematic Assessment |
| |
| Tracheostomy | Surgical and medical procedures | 16.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | 16.1 | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | 16.1 | Systematic Assessment |
| |
| Aortic intramural haematoma | Vascular disorders | 16.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 16.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | 16.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 16.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 16.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 16.1 | Systematic Assessment |
|
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 |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C530716 | nintedanib |
Not provided
Not provided
Not provided
| Male |
|
Within-patient errors are modelled by an Unstructured variance-covariance matrix. Inter-individual variability is modelled by a Variance-components variance-covariance matrix. Nintedanib 150 mg bid versus Placebo. |
| No |
| Superiority or Other |
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