Trial intelligence / Profile preview

Nebulized Fluticasone vs Prednisone in Pediatric Acute Asthma

NCT01687296Phase 3

Key facts

Status: Completed
Start: Nov 2012
Primary completion: Jun 2013
Countries: 1
Sponsor: GSK
Modality: Orthosteric Ligands

Drugs: fluticasone propionate nasal spray
Conditions: asthma

Overview

Phase 3, randomised, double-blind trial of fluticasone propionate nasal spray in asthma (2 arms), sponsored by GSK. Primary endpoint: Mean Morning Peak Expiratory Flow. Started Nov 2012; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Nebulized Fluticasone
Fluticasone Propionate Nebules 1mg BID + Placebo Tablets
Oral Prednisone
Oral Prednisone OD + Placebo Nebules

Who it enrols

Chinese pediatric subjects (4-16 years) with a diagnosis of asthma and an acute exacerbation defined by PEF 50-75% predicted and clinical score >=2.

Endpoints

Primary

Mean Morning Peak Expiratory FlowDays 2 to 8

Secondary

Mean Evening Peak Expiratory FlowDays 1/2 to 8
Median Day-time and Night-time Symptom ScoresDays 2 to 8
Median Number of Use of Rescue MedicationsDays 2 to 8
Forced Expiratory Volume in 1 SecondDay 8
Forced Vital CapacityDay 8
Mean Change From Baseline in Clinical Scoring IndexDay 8
Mean Global Evaluation for EfficacyDay 8

Results

Primary endpoints met

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