Clinical Assessment Of GW815SF Salmeterol/Fluticasone Propionate(HFA MDI) In Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-

Phase 3

Completed

• Conditions: Bronchial Asthma

• Registration Number: NCT00449046
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study evaluates the long-term (24-week) safety and efficacy of GW815SF Salmeterol/fluticasone propionate(HFA MDI) 50/100mcg(administered as 2 inhalations of 25/50mcg) bid in pediatric patients with bronchial asthma.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-16
• Study First Submitted QC: 2007-03-16
• Study First Posted: 2007-03-19
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Results First Submitted: 2008-11-21
• Results First Submitted QC: 2009-06-18
• Results First Posted: 2009-08-04
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Most Frequent Adverse Events - On Therapy	Baseline to Week 24	Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.
Serious Adverse Events (SAEs) - On Therapy	Baseline to Week 24	Number of participants considered by the investigator to be related to study medication.; Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24	Baseline and during Weeks 1-24	PEF taken daily and average used for week 1-24 value. The peak expiratory flow rate measures how fast a person can (exhale) air. Then, compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24	Baseline and during Weeks 1-24	Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning.
Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24	Baseline and during Weeks 1-24	The peak expiratory flow rate measures how fast a person can (exhale) air. Then compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24	Baseline and during Weeks 1-24	Circadian Variation means the various changes in a day. The peak expiratory flow rate measures how fast a person can (exhale) air using a mini-Wright peak flow meter. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Number of Participants With Symptom-Free Nights and Days	Baseline and Week 24
Number of Participants With Rescue Medication-Free Nights and Days	Baseline and Week 24	Rescue free means without the use of other medication.

Trial Locations

Locations (1)

GSK Clinical Trials Call Center; 🇯🇵 Takasaki, Gunma, Japan