Treatment Of Symptomatic Asthma In Children

Phase 4

Completed

Conditions: Asthma

Interventions: Drug: fluticasone propionate 2 x 100 mcg
Drug: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg

Registration Number: NCT00197106

Lead Sponsor: GlaxoSmithKline

Brief Summary: This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.

Detailed Description: A multicentre, randomised, double blind, parallel group study to compare the efficacy and safety of Salmeterol/Fluticasone propionate combination product (Seretide®) 50/100mcg with Fluticasone propionate (Flixotide®) 200mcg, both delivered twice daily via the DISKUS inhaler, in the treatment of children aged 6-12 years with symptomatic asthma.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 176

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fluticasone propionate 2 x 100 mcg	fluticasone propionate 2 x 100 mcg	fluticasone propionate 2 x 100 mcg
Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg	Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg	Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg

Primary Outcome Measures

Name	Time	Method
Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period	Last 10 weeks of the treatment period (Weeks 16-26)	Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary.

Secondary Outcome Measures

Name	Time	Method
Percentage of Symptom-free Days During the Entire Treatment Period	Baseline to Week 26	Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary
Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1)	26 weeks	Daily FEV1 and PEF via the electronic pea kflow/FEV1 meter (PIKO-1) was not assessed because data from the peak flow meters could not be used for analysis.
Cumulative Number of Symptom-free Weeks Until the End of Treatment	26 weeks	This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.
Geometric Means of Nitric Oxide (NO) at Week 26	Baseline and Week 26	Geometric mean values of NO at week 26 were compared using ANCOVA with adjustment for baseline value of NO, age, gender and center. Analysis of covariance (ANCOVA) is a general linear model with one continuous outcome variable (quantitative) and one or more factor variables.
Number of Asthma Exacerbations Per Treatment Group at Week 26	Week 26	An exacerbation is defined as a worsening of the asthma complaints (commonly referred to as an asthma attack) and is reported by the participant experiencing the event. An exacerbation was verified by the use of asthma rescue medication.
Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26	Baseline and Week 26	PD20 was calculated by using increasing dosages of methacholine. The dosage that caused a 20% fall in FEV1 was used for analysis. The presented data are ratios (month 6/Baseline) of geometric mean PD20 values.
Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres	26 weeks	Bronchial hyperresponsiveness with PD20 AMP in selected centres was not analyzed, as this outcome measure was removed in a protocol amendment.
Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26	Baseline and Week 26	Change from Baseline was calculated as the Week 26 value minus the Baseline value. The percentage predicted FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath and is corrected for the FEV1 value corresponding with the same age.
Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26	Baseline and Week 26	Change from Baseline was calculated as the Week 26 value minus the Baseline value. Forced vital capacity is defined as the maximum volume of air that can be forcibly expired from the lungs and is calculated by use of spirometry. The spirometry test is performed by using a device called a spirometer, which measures the amount of air one can blow out maximally. Generally, the participant is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible. The test is normally repeated three times to ensure reproducibility.
Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26	Baseline and Week 26	Change from Baseline was calculated as the Week 26 value minus the Baseline value. MEF 50 is defined as maximum expiratory flow rate at 50% of vital capacity. Vital capacity is the maximum amount of air that a person can expel from the lungs after first filling the lungs to their maximum extent. Midexpiratory flow was calculated by use of spirometry. The test is normally repeated at least three times in order to ensure reproducibility.
Percent Change From Baseline in RINT Measurements at Week 26	Baseline and Week 26	Change from Baseline was calculated as the Week 26 value minus the Baseline value. Interrupter respiratory resistance (RINT) measurements were calculated by a combined analysis for relation between change from baseline and occurrence of the endpoint. RINT is a technique that is used for evaluating lung function in poorly collaborating patients (e.g., small children). The measurement is performed during tidal breathing (normal breathing) instead of during maximal expiration, as is done by a spirometry test.
Weekly Percentage of Participants With 'Good Controlled Weeks' and 'Maximal Controlled Weeks'	26 weeks	This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.
Frequency of Asthma Exacerbations (Discriminated on Severity)	26 weeks	The frequency of asthma exacerbations (discriminated on severity) was not analyzed because of the low overall frequency.
Time to Asthma Control, Defined as the Time to First 'Good Controlled Week' or 'Maximum Controlled Week'	26 weeks	This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.