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A Double-blind, Double Dummy, Randomised, Parallel Group, Multicentre Study to Compare the Efficacy and Safety of Flutiform pMDI With Fluticasone pMDI and With Seretide pMDI in Paediatric Subjects Aged 5 to Less Than 12 Years With Moderate to Severe Persistent Reversible Asthma.

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A Double-blind, Double Dummy, Randomised, Parallel Group, Multicentre Study to Compare the Efficacy and Safety of Flutiform pMDI With Fluticasone pMDI and With Seretide pMDI in Paediatric Subjects Aged 5 to Less Than 12 Years With Moderate to Severe Persistent Reversible Asthma.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Formoterol/fluticasone propionate (Primary) ; Fluticasone propionate; Salmeterol/fluticasone propionate
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Sponsors Mundipharma International

    • Most Recent Events

    • 08 Nov 2018 According to a Mundipharma international media release, based on data from this and other paediatric study, the Mundipharma network of independent associated companies today announced that the European Decentralised Procedure (DCP) licence variation application for flutiform, extending the indication to the treatment of asthmatic children, has closed with a positive opinion.
    • 13 Feb 2014 According to ClinicalTrials.gov record, status changed from active, no longer recruiting to completed.
    • 22 Oct 2013 Planned end date changed from 1 Apr 2013 to 1 Nov 2013 as reported by ClinicalTrials.gov.

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