drugset / Trial / NCT03387241

Efficacy of FLUTIFORM ® vs Seretide® in Moderate to Severe Persistent Asthma in Subjects Aged ≥12 Years

NCT03387241

Phase 3 Unknown 330 enrolled Mundipharma (China) Pharmaceutical Co. Ltd
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A double blind, double dummy, randomised, multicentre, two arm parallel group study to assess the efficacy and safety of FLUTIFORM® pMDI (2 puffs bid) vs Seretide® pMDI (2 puffs bid) in subjects aged ≥12 years with moderate to severe persistent, reversible asthma.

Timeline

Start
2017-06-02
Primary completion
2019-12-30
Completion
2020-03-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone Other / unclassified 50 ug Inhaled
Comparator Fluticasone Other / unclassified 125 ug Inhaled
Comparator Fluticasone Other / unclassified 250 ug Inhaled
Subject Formoterol Other / unclassified 5 ug Inhaled
Subject Formoterol Other / unclassified 10 ug Inhaled
Comparator Salmeterol Other / unclassified 25 ug Inhaled

Indications