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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01687296
First received: September 6, 2012
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Asthma
Drug: fluticasone propionate inhalation solution
Drug: oral prednisone
Drug: placebo inhalation solution
Drug: placebo tablet
Drug: salbutamol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • morning PEF (peak expiratory flow) [ Time Frame: 7-day treatment ] [ Designated as safety issue: No ]
    mean morning PEF over treatment period


Secondary Outcome Measures:
  • evening PEF [ Time Frame: 7-day treatment ] [ Designated as safety issue: No ]
    mean evening PEF over treatment period

  • Day-time and night-time symptom scores [ Time Frame: 7-day treatment ] [ Designated as safety issue: No ]
    Day-time and night-time symptom scores over the treatment assessment period

  • Rescue medications [ Time Frame: 7-day treatment ] [ Designated as safety issue: No ]
    Rescue medications during day and night over the treatment assessment period

  • Clinic assessments of lung function [ Time Frame: 7-day tratment ] [ Designated as safety issue: No ]
    Clinic assessments of lung function (FEV1 and FVC) at each clinical visit

  • Clinical scoring index [ Time Frame: 7-day treatment ] [ Designated as safety issue: No ]
    Clinical scoring index at each clinical visit

  • Patient/parent and investigator global evaluation [ Time Frame: 7-day treatment ] [ Designated as safety issue: No ]
    Patient/parent and investigator global evaluation


Enrollment: 261
Study Start Date: November 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fluticasone Nebules/placebo tablet
2×0.5mg/2ml twice daily neblulized/placebo tablet, oral, once daily
Drug: fluticasone propionate inhalation solution
2×0.5mg/2ml twice daily nebulized to treat an acute exacerbation of asthma for 7 days
Drug: placebo tablet
placebo soluble tablet, oral ,once daily
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.
Active Comparator: 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
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
Drug: placebo inhalation solution
4ml 0.9% saline nebulized twice daily
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.

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

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687296

Locations
China, Hunan
GSK Investigational Site
Changsha, Hunan, China, 410005
China, Jilin
GSK Investigational Site
Yanji, Jilin, China, 133000
China, Liaoning
GSK Investigational Site
Shenyang, Liaoning, China, 110004
China, Zhejiang
GSK Investigational Site
Wenzhou, Zhejiang, China, 323027
China
GSK Investigational Site
Beijing, China
GSK Investigational Site
Beijing, China, 100191
GSK Investigational Site
Changchun, China
GSK Investigational Site
Chongqing, China, 400014
GSK Investigational Site
Shanghai, China, 200040
GSK Investigational Site
Shanghai, China, 200092
GSK Investigational Site
Wuxi, China, 214023
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01687296     History of Changes
Other Study ID Numbers: 114220
Study First Received: September 6, 2012
Last Updated: November 21, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
PEF
inhaled
Fluticasone Propionate
safety
prednisone
acute exacerbation
asthma
efficacy

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Fluticasone
Prednisone
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 18, 2014