Study of Formoterol 6 mcg/Fluticasone 125 mcg by Eurofarma Laboratórios S.A. Versus Alenia® 6 mcg/200 mcg in Patients With Asthma (FORASMA)

Study acronym: FORASMA
StatusWithdrawn
PhasePhase 3
Started

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Record History

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  1. Withdrawn before enrolling Sponsor's reason: Strategic change in development priorities.
    • Enrollment target: estimated 174 to confirmed 0
    • Interventions: Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) (Drug), N0783 (Drug) to Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) (Drug), N0783 (Drug)
    • Eligibility criteria expanded, about 15 words
  2. Study title shortened, about 5 wordsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 3, multicenter, randomized, parallel-group, open-label, non-inferiority clinical trial designed to evaluate the efficacy and safety of N0783 compared to Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) in the treatment of moderate asthma. Adult patients diagnosed with moderate asthma according to clinical and functional criteria will be enrolled. The primary objective is to demonstrate that N0783 is not inferior to Alenia® in improving asthma control. Participants will receive treatment according to the assigned intervention and will be monitored through scheduled visits for assessment of lung function, symptom control, and safety parameters throughout the study period.
Trial Details
NCT Number NCT07318350
Lead Sponsor Eurofarma Laboratorios S.A.
Conditions
(from sponsor)		 Moderate Asthma
Related terms Asthma
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov