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A Six Month Double Blind Randomized Placebo Controlled Trial Followed by Each Arm Being Converted to Oral Nintedanib 150 mg Twice Daily Comparing the Effect on High Resolution Computerized Tomography Quantitative Lung Fibrosis Score, Lung Function, Six Minute Walk Test Distance and St. George's Respiratory Questionnaire After Six Months of Treatment in Patients With Idiopathic Pulmonary Fibrosis With Continued Evaluations Over a Period of up to Eighteen Months

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Trial Profile

A Six Month Double Blind Randomized Placebo Controlled Trial Followed by Each Arm Being Converted to Oral Nintedanib 150 mg Twice Daily Comparing the Effect on High Resolution Computerized Tomography Quantitative Lung Fibrosis Score, Lung Function, Six Minute Walk Test Distance and St. George's Respiratory Questionnaire After Six Months of Treatment in Patients With Idiopathic Pulmonary Fibrosis With Continued Evaluations Over a Period of up to Eighteen Months

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Sep 2023

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At a glance

  • Drugs Nintedanib (Primary)
  • Indications Idiopathic pulmonary fibrosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Boehringer Ingelheim

    • Most Recent Events

    • 30 Aug 2023 Results of pooled analysis from NCT00514683, NCT01335464, NCT01335477, NCT01979952, NCT02999178, NCT02597933, assessing decline in forced vital capacity (FVC) as a surrogate for mortality, published in the Respirology
    • 19 May 2021 Results of pooled analysis (n=2553) assessing decline in forced vital capacity (FVC) as a surrogate for mortality from NCT00514683, NCT01335464, NCT01335477, NCT01979952, NCT02597933 and NCT02999178 trials, presented at the 117th International Conference of the American Thoracic Society.
    • 20 May 2020 Results (n=1690) of pooled analysis of five studies (TOMORROW, INPULSIS-1, 2, INMARK & NCT01979952) assessing efficacy and safety of nintedanib in patients with IPF and multiple comorbidities in < vs ≥5 comorbidities sub-groups, presented at the 116th International Conference of the American Thoracic Society.
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