Nebulized Fluticasone Propionate VS Oral Prednisone in Chinese Pediatric and Adolescent Subjects With an Acute Exacerbation of Asthma

• Status: Completed
• Trial end date: 2013-06-21
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Albuterol; Fluticasone; Pharmaceutical Solutions; Prednisone; Xhance

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.