NCT01687296

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

Completed Phase 3 Results posted Last updated 20 June 2018

What this trial tests

Phase 3 trial testing fluticasone propionate inhalation solution in Asthma in 261 participants. Completed in 21 June 2013.

Timeline

12 November 2012

Primary endpoint
1 June 2013

21 June 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	261
Start date	12 November 2012
Primary completion	1 June 2013
Estimated completion	21 June 2013
Sites	11 locations across China

Drugs / interventions tested

• fluticasone propionate inhalation solution
• oral prednisone — full drug profile →
• placebo inhalation solution — full drug profile →
• placebo tablet
• salbutamol (salbutamol) — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 4 to 16, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population Primary · Days 2 to 8

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 pro

Group	Value	95% CI
Fluticasone Propionate	188.77	± 3.774
Prednisone	188.31	± 3.790

Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population Primary · Days 2 to 8

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 pr

Group	Value	95% CI
Fluticasone Propionate	189.46	± 3.724
Prednisone	188.96	± 3.712

Mean Evening PEF on Diary Card Over the Treatment Assessment Period Secondary · Days 1/2 to 8

PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the evening (6:00-9:00 post meridiem \[PM\]) before taking any study drug. Only data that was drawn from Days 1/2 to 8 after randomization and before or on the end date of study drug was used for analysis. If participants started to take the study drug in the morning (early or on 12:00 PM), only then the evening PEF on the date of randomization was used. The outcome measure was considere

Group	Value	95% CI
Fluticasone Propionate	195.79	± 3.723
Prednisone	194.63	± 3.751

Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period Secondary · Days 2 to 8

The symptoms of cough, sputum production, wheeze and dyspnoea were assessed in morning and evening, and recorded on participant diary cards. Day-time symptoms were scored while retiring to bed on a scale of 0 (no symptoms) to 5 (severe). Night-time symptoms were scored while waking in the morning on a scale of 0 (no symptoms) to 4 (severe). For day-time score, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. For night-time score, only data that are from Days 2 to 8 after randomization and on or before one day after the end date of st

Day-time symptom score

Group	Value	95% CI
Fluticasone Propionate	0.5	0 – 3
Prednisone	1.0	0 – 3

Night-time symptom score

Group	Value	95% CI
Fluticasone Propionate	0.0	0 – 3
Prednisone	0.0	0 – 4

Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period Secondary · Days 2 to 8

The use of nebulized salbutamol (doses/puffs and frequency) were recorded on diary card in the morning and evening. The median numbers of times of use of rescue medication during day and night was calculated for each participant over the treatment assessment period. In each case, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. The outcome measure was considered missing if less than 2 days (that is., 24-hour periods) were recorded in the given treatment assessment period. The analysis only includes participants who have at least 2 da

Group	Value	95% CI
Fluticasone Propionate	2.0	0 – 3
Prednisone	2.0	0 – 3

Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period Secondary · During the treatment period at Day 5, Day 8

Spirometric assessments of FEV1 and FVC were assessed at clinic visit 1 (Screening), 2 (Day 5) and 3 (Day 8). Lung function tests were performed at the approximately same time at each visit in the morning. Participants were instructed to withhold salbutamol therapy for at least 4 hour, and the highest of three FEV1 and FVC measurements were recorded. If participants discontinued before or on Day 5, then the FEV1 and FVC collected at the early withdrawal visit is included in the Visit 2. Otherwise, the FEV1, FVC collected at the early withdrawal visit was included in the Visit 3. Analysis was p

FEV1, Day 5

Group	Value	95% CI
Fluticasone Propionate	1.288	± 0.0348
Prednisone	1.331	± 0.0332

FEV1, Day 8

Group	Value	95% CI
Fluticasone Propionate	1.400	± 0.0294
Prednisone	1.396	± 0.0280

FVC, Day 5

Group	Value	95% CI
Fluticasone Propionate	1.476	± 0.0454
Prednisone	1.543	± 0.0439

FVC, Day 8

Group	Value	95% CI
Fluticasone Propionate	1.544	± 0.0326
Prednisone	1.582	± 0.0316

Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8 Secondary · Baseline, Day 5 and Day 8

The clinical scoring index was assessed at Baseline (Visit 1), Day 5 and Day 8. The score assigned represented the sum of the score for each of four signs: respiratory rate, wheezing, inspiration/expiration ratio, and accessory muscle use. Each of these parameters were scored on a 4-point scale of 0 to 3 where 0=none, 1=mild, 2=moderate and 3=severe. The total score ranged from 0 to 12, where 0 indicated absence of symptoms and 12 indicated most severe symptoms. The Baseline value was the last non-missing value prior to randomization. Change from Baseline was calculated/defined as value at the

Day 5

Group	Value	95% CI
Fluticasone Propionate	-2.7	± 1.41
Prednisone	-2.6	± 1.44

Day 8

Group	Value	95% CI
Fluticasone Propionate	-3.4	± 1.26
Prednisone	-3.4	± 1.26

Mean Global Evaluation for Efficacy by Participant/Parent and Investigator Secondary · Day 8

At Visit 3 (Day 8), participant/parent and investigator were asked to evaluate efficacy globally as very beneficial=1, beneficial=2, no effect=3 or worse=4. The global evaluation collected at the early withdrawal visit was included in the Visit 3. If participants were discontinued at Visit 2, then the global evaluation collected at the Visit 2 is also included in the Visit 3 for summary and analysis.

Participant/parent global evaluation

Group	Value	95% CI
Fluticasone Propionate	1.5	± 0.59
Prednisone	1.5	± 0.52

Investigator global evaluation

Group	Value	95% CI
Fluticasone Propionate	1.5	± 0.56
Prednisone	1.5	± 0.52

Adverse events — posted to ClinicalTrials.gov

Time frame: On- treatment serious adverse events (SAE) and non- serious adverse events (AE) were collected from start of study medication through the treatment phase up to 8 days (only on-treatment events captured).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fluticasone Propionate

Serious: 1/123 (1%)

Deaths: 0/123

Prednisone

Serious: 2/128 (2%)

Deaths: 0/128

Serious adverse events (1 terms)

Reaction	System	Fluticasone Propionate	Prednisone
Upper respiratory tract infection	Infections and infestations	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Fluticasone Propionate	Prednisone
White blood cell count increased	Investigations	—	—

Most-reported serious reactions: Upper respiratory tract infection.

Data from ClinicalTrials.gov NCT01687296 adverse events section.

Sponsor's own 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 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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.