Clinical trial NCT01687296: Nebulized Fluticasone Propionate VS Oral Prednisone in Chinese Pediatric and Adolescent Subjects With an Acute Exacerbation of Asthma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: PEF
inhaled
Fluticasone Propionate
safety
prednisone
acute exacerbation
asthma
efficacy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-09-18
Enrollment: 261
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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 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.

Primary outcomes:
measure: Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population
timeFrame: Days 2 to 8
measure: Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population
timeFrame: Days 2 to 8
Secondary outcomes:
measure: Mean Evening PEF on Diary Card Over the Treatment Assessment Period
timeFrame: Days 1/2 to 8
measure: Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period
timeFrame: Days 2 to 8
measure: Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period
timeFrame: Days 2 to 8
measure: Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period
timeFrame: During the treatment period at Day 5, Day 8
measure: Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8
timeFrame: Baseline, Day 5 and Day 8
measure: Mean Global Evaluation for Efficacy by Participant/Parent and Investigator
timeFrame: Day 8
Other outcomes:
Locations:
city: Changsha
country: China
facility: GSK Investigational Site
state: Hunan
city: Yanji
country: China
facility: GSK Investigational Site
state: Jilin
city: Shenyang
country: China
facility: GSK Investigational Site
state: Liaoning
city: Wenzhou
country: China
facility: GSK Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Changchun
country: China
facility: GSK Investigational Site
city: Chongqing
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Wuxi
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: