Efficacy and Safety of Fluticasone Nebules in Chinese Asthmatic Pediatric and Adolescent Subjects With an Acute Exacerbation

• morning PEF (peak expiratory flow) [ Time Frame: 7-day treatment ] [ Designated as safety issue: No ]
  mean morning PEF over treatment period
  
  

• evening PEF [ Time Frame: 7-day treatment ] [ Designated as safety issue: No ]
  mean evening PEF over treatment period
  
  
• Day-time and night-time symptom scores [ Time Frame: 7-day treatment ] [ Designated as safety issue: No ]
  Day-time and night-time symptom scores over the treatment assessment period
  
  
• Rescue medications [ Time Frame: 7-day treatment ] [ Designated as safety issue: No ]
  Rescue medications during day and night over the treatment assessment period
  
  
• Clinic assessments of lung function [ Time Frame: 7-day tratment ] [ Designated as safety issue: No ]
  Clinic assessments of lung function (FEV1 and FVC) at each clinical visit
  
  
• Clinical scoring index [ Time Frame: 7-day treatment ] [ Designated as safety issue: No ]
  Clinical scoring index at each clinical visit
  
  
• Patient/parent and investigator global evaluation [ Time Frame: 7-day treatment ] [ Designated as safety issue: No ]
  Patient/parent and investigator global evaluation
  
  

This is a multicentre, randomized, double-blind, double-dummy, active-controlled, parallel-group study to determine the efficacy and safety of nebulized fluticasone propionate (FP) 1mg twice daily compared with oral prednisone administered for 7 days to Chinese pediatric and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma. This study is for supporting registration of FP Nebules treating Chinese pediatric and adolescent subjects (aged 4 to 16 years) with an acute exacerbation of asthma in China.

At least 250 subjects, aged 4-16 years old, diagnosed an acute exacerbation of asthma at presentation, are eligible to take part in the study if they meet the inclusion criteria. They are randomly assigned at the ratio 1:1 to one of the following treatment groups for 7 days: FP Nebules 2×0.5mg/2ml twice daily/Placebo tablets once daily; Or, Oral prednisone tablets once daily (2mg/kg.day, up to 40mg/day for 4 days, then 1mg/kg.day or half of the original dose, up to 20mg/day for 3 days) / Placebo Nebules 2×2ml 0.9% saline twice daily. While all subjects are given Salbutamol Nebules / MDI for relief of symptoms. After randomization (visit 1), the following visits are on Day5 (visit 2) and Day8 (visit 3), and a follow-up phone call (visit4) will happen two weeks post treatment on Day 21 for collection of adverse events.

The primary endpoint is mean morning PEF on diary card over the treatment assessment period. The secondary endpoints include subject derived data (symptom scores ), evening PEF on diary card, use of rescue medications, clinic assessments of pulmonary function ( FEV1, and FVC) , clinical scoring index , patient/parent and investigator global evaluation, and use of rescue medications during the trial. Safety endpoints include AEs, vital signs, and oropharyngeal examinations, and laboratory tests (haematology, urinalysis, chemistry). The subjects are assessed for compliance on completion of diary card.