Nebulized Fluticasone Propionate VS Oral Prednisone in Chinese Pediatric and Adolescent Subjects With an Acute Exacerbation of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicentre, randomized, double-blind, double-dummy, active-controlled,
      parallel-group study to determine the efficacy and safety of nebulized fluticasone propionate
      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
    

Detailed description: 
      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.
    

Intervention name(s): fluticasone propionate inhalation solution; oral prednisone; placebo inhalation solution; placebo tablet; salbutamol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2×0.5mg/2ml twice daily nebulized to treat an acute exacerbation of asthma for 7 days; 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) to treat an acute exacerbation of asthma for 7 days; 4ml 0.9% saline nebulized twice daily; placebo soluble tablet, oral ,once daily; Salbutamol MDI 2 puffs twice daily or Nebules twice daily, and can be increased up to every 4 hours on an as-needed basis, through the treatment period.
Intervention MeSH terms: Fluticasone; Xhance; Prednisone; Pharmaceutical Solutions; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: PEF; inhaled; Fluticasone Propionate; safety; prednisone; acute exacerbation; asthma; efficacy