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

NCT ID: NCT01687296

Last Updated: 2018-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-12
• Study Completion Date: 2013-06-21

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

fluticasone Nebules/placebo tablet

2×0.5mg/2ml twice daily neblulized/placebo tablet, oral, once daily

Group Type: EXPERIMENTAL

fluticasone propionate inhalation solution

Intervention Type: DRUG

2×0.5mg/2ml twice daily nebulized to treat an acute exacerbation of asthma for 7 days

placebo tablet

Intervention Type: DRUG

placebo soluble tablet, oral ,once daily

salbutamol

Intervention Type: DRUG

Salbutamol MDI 2 puffs twice daily or Nebules twice daily, and can be increased up to every 4 hours on an as-needed basis, through the treatment period.

oral prednisone/placebo inhalation solution

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 inhalation solution nebulized twice daily

Group Type: ACTIVE_COMPARATOR

oral prednisone

Intervention Type: DRUG

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) to treat an acute exacerbation of asthma for 7 days

placebo inhalation solution

Intervention Type: DRUG

4ml 0.9% saline nebulized twice daily

salbutamol

Intervention Type: DRUG

Salbutamol MDI 2 puffs twice daily or Nebules twice daily, and can be increased up to every 4 hours on an as-needed basis, through the treatment period.

Interventions

fluticasone propionate inhalation solution

2×0.5mg/2ml twice daily nebulized to treat an acute exacerbation of asthma for 7 days

Intervention Type: DRUG

oral prednisone

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) to treat an acute exacerbation of asthma for 7 days

Intervention Type: DRUG

placebo inhalation solution

4ml 0.9% saline nebulized twice daily

Intervention Type: DRUG

placebo tablet

placebo soluble tablet, oral ,once daily

Intervention Type: DRUG

salbutamol

Salbutamol MDI 2 puffs twice daily or Nebules twice daily, and can be increased up to every 4 hours on an as-needed basis, through the treatment period.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Changsha, Hunan, China

GSK Investigational Site

Yanji, Jilin, China

GSK Investigational Site

Shenyang, Liaoning, China

GSK Investigational Site

Wenzhou, Zhejiang, China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Changchun, , China

GSK Investigational Site

Chongqing, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Wuxi, , China

Countries

China

Other Identifiers

114220

Identifier Type: -

Identifier Source: org_study_id