Phase 3 N=251 Randomized Triple-blind Treatment

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

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT01687296 ↗

Enrolled (actual)

251

Serious AEs

1.2%

Results posted

Jan 2018

Primary outcome: Primary: Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population — 188.77; 188.31 Litres per minute (L/min) — p=0.931

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: fluticasone propionate inhalation solution (Drug); oral prednisone (Drug); placebo inhalation solution (Drug); placebo tablet (Drug); salbutamol (Drug)
Age: Pediatric · 4+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population	188.77; 188.31	0.931
PRIMARY Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population	189.46; 188.96	0.922
SECONDARY Mean Evening PEF on Diary Card Over the Treatment Assessment Period	195.79; 194.63	0.822
SECONDARY Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period	0.5; 1.0; 0.0; 0.0	0.717
SECONDARY Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period	2.0; 2.0	0.996
SECONDARY Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period	1.288; 1.331; 1.400; 1.396; 1.476; 1.543	0.348
SECONDARY Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8	-2.7; -2.6; -3.4; -3.4	0.507
SECONDARY Mean Global Evaluation for Efficacy by Participant/Parent and Investigator	1.5; 1.5; 1.5; 1.5	0.633

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01687296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.