At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Single Blind, Active Controlled, Parallel Group Study to Determine Efficacy and Safety of Nebulized Fluticasone Propionate 1mg BID Compared With Nebulized Budesonide 2mg BID Administered for 12 Weeks in Chinese Adult and Adolescent Patients With Severe Persistent Asthma
In Brief
A Phase 3 clinical trial evaluating fluticasone propionate inhalation solution and budesonide suspension for Asthma. Completed, enrolled 316 participants across 25 sites.
Detailed Summary
This is a multicentre, randomized, single-blind, active-controlled, parallel-group phase III local registration study for a treatment period of 12 weeks. This study aims to assess the effectiveness and safety of fluticasone propionate 1mg via nebulizer BID in treatment of Chinese adult and adolescent patients with severe persistent asthma for a treatment period of 12 weeks versus budesonide 2mg via nebulizer BID. The steady-state plasma pharmacokinetics of fluticasone propionate inhalation solution will also be assessed.
Study Details
Timeline
Interventions
1 mg BID inhalation for 12 weeks with one possible chance to change to 0.5 mg BID
2 mg BID inhalation for 12 weeks with one possible chance to change to 1 mg BID