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

NCT01687296 | Completed Phase 3 Results

• 1 other identifier: 114220
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 11

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

Conditions

Asthma

Keywords

PEF; inhaled; Fluticasone Propionate; safety; prednisone; acute exacerbation; asthma; efficacy

Outcome Measures

Primary Outcomes (2)

• Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population

  PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before taking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 4 participants from prednisone group had the missing outcome measure. Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to gender, age, centre and treatment group.

  Days 2 to 8

• Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population

  PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before talking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using ANCOVA model with effects due to gender, age ,centre and treatment group.

  Days 2 to 8

Secondary Outcomes (6)

• Mean Evening PEF on Diary Card Over the Treatment Assessment Period

  Days 1/2 to 8

• Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period

  Days 2 to 8

• Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period

  Days 2 to 8

• Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period

  During the treatment period at Day 5, Day 8

• Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8

  Baseline, Day 5 and Day 8

Study Arms (2)

fluticasone Nebules/placebo tablet

EXPERIMENTAL

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

Drug: fluticasone propionate inhalation solution; Drug: placebo tablet; Drug: salbutamol

oral prednisone/placebo inhalation solution

ACTIVE COMPARATOR

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; Drug: placebo inhalation solution; Drug: salbutamol

Interventions

fluticasone propionate inhalation solution DRUG

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

fluticasone Nebules/placebo tablet

oral prednisone 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

oral prednisone/placebo inhalation solution

placebo inhalation solution DRUG

4ml 0.9% saline nebulized twice daily

oral prednisone/placebo inhalation solution

placebo tablet DRUG

placebo soluble tablet, oral ,once daily

fluticasone Nebules/placebo tablet

salbutamol 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.

fluticasone Nebules/placebo tablet; oral prednisone/placebo inhalation solution

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

Changsha, Hunan, 410005, China

Location

GSK Investigational Site

Yanji, Jilin, 133000, China

Location

GSK Investigational Site

Shenyang, Liaoning, 110004, China

Location

GSK Investigational Site

Wenzhou, Zhejiang, 323027, China

Location

GSK Investigational Site

Beijing, 100191, China

Location

GSK Investigational Site

Beijing, China

Location

GSK Investigational Site

Changchun, China

Location

GSK Investigational Site

Chongqing, 400014, China

Location

GSK Investigational Site

Shanghai, 200040, China

Location

GSK Investigational Site

Shanghai, 200092, China

Location

GSK Investigational Site

Wuxi, 214023, China

Location

MeSH Terms

Conditions

Asthma; Respiratory Aspiration

Interventions

Prednisone; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 18, 2012
• Study Start: November 12, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 21, 2013
• Last Updated: June 20, 2018
• Results First Posted: January 30, 2018

Record last verified: 2018-06

Locations

CN (11)