Nebulized Fluticasone Propionate VS Oral Prednisone in Chinese Pediatric and Adolescent Subjects With an Acute Exacerbation of Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: fluticasone propionate inhalation solution; oral prednisone; placebo inhalation solution; placebo tablet; salbutamol
Intervention description: 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 261.0
Sex: All
Minimum age: 4 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: PEF; inhaled; Fluticasone Propionate; safety; prednisone; acute exacerbation; asthma; efficacy

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chinese male and female pediatric or adolescent subjects aged 4 to 16 years, inclusive

          -  Subjects have an established diagnosis of asthma

          -  The definition of asthma. According to Chinese Guideline for the diagnosis and optimal
             management of asthma in children [Respiratory branch of pediatric society,Chinese
             Medical. Association. 2008, revised version], the subjects can be diagnosed when
             meeting the criteria. The diagnosis criteria is listed in the protocol.

          -  The severity of an acute exacerbation of asthma is defined as PEF of 50% to 75%
             predicted via a peak flow meter, with a clinical scoring index of ≥2. The clinical
             scoring index represents the sum of the score for each of four signs: respiratory rate
             (0=low to 3=high, dependent on age), wheezing (0=none to 3=severe),
             inspiration/expiration ratio (0=2:1 to 3=1:3), and accessory muscle (0=none to
             3=marked use).

          -  Subjects can properly use a mini-wright peak flow meter, nebulizer and MDI
             with/without a spacer, and accurately complete a diary card with parental assistance,
             if required.

          -  Subjects' parents/guardians are willing to give written informed consent.

        Exclusion criteria:

          -  Severe respiratory dysfunction.

          -  History of mechanical ventilation due to respiratory failure.

          -  Admission to hospital due to respiratory disease within the previous 2 weeks,
             including asthmatic exacerbations.

          -  Clinical or lab evidence of a serious, uncontrolled systemic disease or presence of
             any disease likely to interfere with the objectives of this study, such as pulmonary
             cystic fibrosis and bronchopulmonary dysplasia.

          -  Known or suspected hypersensitivity to glucocorticosteroids or β2 agonists.

          -  Clinical visual evidence of oral candidiasis at Visit1.

          -  Use of the medications below in Table 1 according to the following defined time
             intervals prior to presentation. The list is provided in the protocol.