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An Exploratory, Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy, Safety and Tolerability of a Single and a Repeated Dose of Oral BCT197 in Patients With an Acute COPD Exacerbation.

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An Exploratory, Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy, Safety and Tolerability of a Single and a Repeated Dose of Oral BCT197 in Patients With an Acute COPD Exacerbation.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 23 Mar 2023

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At a glance

  • Drugs Acumapimod (Primary) ; Prednisone
  • Indications Chronic obstructive pulmonary disease
  • Focus Pharmacogenomic; Therapeutic Use
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 24 May 2017 Primary endpoint (The improvement in FEV1 over the first 5 days of treatment in Parts I and II, and improvement in FEV1 over the first 10 days in Parts III and IV, relative to placebo.) has not been met as per the results presented at the 113th International Conference of the American Thoracic Society
    • 24 May 2017 Results (n=169) evaluating primary end points and results of post hoc analysis, presented at the 113th International Conference of the American Thoracic Society
    • 01 May 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov.

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