Asthma
Conditions
Interventions
Product Name: fluticasone propionate
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: FLUTICASONE PROPIONATE
CAS Number: 80474-14-2
Other descriptive name: FLUTICASONE PROPIONATE
Concentr
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion 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. 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
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 - Median Day-time and night-time symptom scores over the treatment assessment period - Median number of use of rescue medications during and night over the treatment assessment period -Clinic lung functions results performed in the clinic (FEV1 and FVC) -Clinical scoring index -Patient/ parent and investigator global evaluation | — |
Countries
China
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed