Comparison of safety and efficacy of asthma treatments; fluticasone propionate and oral predinisone
- Conditions
- AsthmaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-004870-14-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 251
- 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 251
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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 ß2 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the efficacy and safety of nebulized fluticasone propionated 1mg BID compared with oral prednisone administered for 7 days to Chinese pediatric and adolescent subjects (aged 4 to 16 years) with an acute exacerbatio of asthma. ;Secondary Objective: Not applicable. ;Primary end point(s): Mean morning PEF on diary card over the treament assessment period;Timepoint(s) of evaluation of this end point: 7 days
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 7 days;Secondary end point(s): - Mean evening PEF on diary card over the treatment assessment period<br>- Median Day-time and night-time symptom scores over the treatment assessment period<br>- Median number of use of rescue medications during and night over the treatment assessment period<br>-Clinic lung functions results performed in the clinic (FEV1 and FVC)<br>-Clinical scoring index<br>-Patient/ parent and investigator global evaluation