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A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma

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A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2023

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At a glance

  • Drugs Budesonide/salbutamol (Primary) ; Salbutamol sulfate
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms MANDALA
  • Sponsors Avillion

    • Most Recent Events

    • 13 Sep 2023 Results (n=2027) assessing use patterns of as-needed ABD and A in MANDALA presented at the 33rd Annual Congress of the European Respiratory Society
    • 24 May 2023 Results of pre-specified analysis (n=2590) assessing the effects of albuterol-budesonide on severe exacerbation risk in patients who are adherent to maintenance therapy, presented at the 119th International Conference of the American Thoracic Society.
    • 27 Feb 2023 Results assessing the effect of as-needed albuterol-budesonide on progression from symptomatic deterioration to severe exacerbation, presented at the 2023 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.

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