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A Randomized, Double-Blind, Parallel Group, Multicenter 12 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants with Inadequately Controlled Asthma (LITHOS)

Trial Profile

A Randomized, Double-Blind, Parallel Group, Multicenter 12 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants with Inadequately Controlled Asthma (LITHOS)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Budesonide/formoterol (Primary) ; Budesonide
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms LITHOS
  • Sponsors AstraZeneca; AstraZeneca AB

Most Recent Events

  • 02 May 2025 Primary endpoint (United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 12) has been met.
  • 02 May 2025 Results presented in the AstraZeneca Media Release.
  • 11 Dec 2024 Status changed from active, no longer recruiting to completed.

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