Conditions: Asthma
Keywords: fluticasone propionate inhalation solution budesonide suspension for inhalation efficacy severe persistent asthma pharmacokinetics safety
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 316
Healthy volunteers: no

Brief 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.

Detailed description:
Male or female subjects between 17 to 70 (inclusive) years of age with severe persistent asthma meeting the inclusion criteria and having completed the screening period of 2 weeks will, in a proportion of 1:1, randomly receive fluticasone propionate 1mg via nebulizer BID or budesonide 2mg via nebulizer BID for a treatment period of 12 weeks. The clinic visit will be arranged at 2 weeks, 4 weeks, 8 weeks and 12 weeks during study treatment. If the subjects meet the criteria of pre-defined asthma control at treatment 4 weeks or 8 weeks, they will have one chance to be treated with the half dose of study drug. 2 weeks after completion of study treatment or after early withdrawal from study, the follow-up visit will be performed to assess the post-treatment adverse events. The primary endpoint is the mean change from baseline in morning peak expiratory flow (PEF) over the 12 week treatment period. Safety assessments include adverse events, vital signs, oral and oropharyngeal candidiasis, hematological, biochemical tests), 24-hour urinary cortisol and 12-lead ECG. The steady-state plasma pharmacokinetics of fluticasone propionate inhalation solution will also be assessed.

Arms:
arm 1: 1 mg BID inhalation via nebulizer arm 2: 2 mg BID inhalation via nebulizer

Interventions: intervention 1: fluticasone propionate inhalation solution intervention 2: budesonide suspension
Intervention descriptions: intervention 1: 1 mg BID inhalation for 12 weeks with one possible chance to change to 0.5 mg BID intervention 2: 2 mg BID inhalation for 12 weeks with one possible chance to change to 1 mg BID

Protocol document: