Nebulized Fluticasone Propionate VS Oral Prednisone in Chinese Pediatric and Adolescent Subjects With an Acute Exacerbation of Asthma
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: fluticasone propionate inhalation solution (Drug); oral prednisone (Drug); placebo inhalation solution (Drug); placebo tablet (Drug); salbutamol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: morning PEF (peak expiratory flow)
Secondary outcome: evening PEFDay-time and night-time symptom scores Rescue medications Clinic assessments of lung function Clinical scoring index Patient/parent and investigator global evaluation
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.
Eligibility
Minimum age: 4 Years.
Maximum age: 16 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Investigational Site, Beijing 100191, China
GSK Investigational Site, Beijing, China
GSK Investigational Site, Changchun, China
GSK Investigational Site, Chongqing 400014, China
GSK Investigational Site, Shanghai 200040, China
GSK Investigational Site, Shanghai 200092, China
GSK Investigational Site, Wuxi 214023, China
GSK Investigational Site, Changsha, Hunan 410005, China
GSK Investigational Site, Yanji, Jilin 133000, China
GSK Investigational Site, Shenyang, Liaoning 110004, China
GSK Investigational Site, Wenzhou, Zhejiang 323027, China
Additional Information
Starting date: November 2012
Last updated: November 21, 2013
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