Official Title: “Pediatric Asthma Clinical Effectiveness Study (PEACE). A Randomized, Double-Blind, Double Dummy, Parallel Group Comparative Clinical Study of Salmeterol/Fluticasone Propionate Inhalation Powder (50/100mcg BID) Via DISKUS† With Oral Montelukast (5mg QD) Chewable Tablets in Children 6-14 Years of Age With Persistent Asthma”

This study is being conducted to demonstrate the superior clinical effectiveness of Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years, and to assess the effect of each treatment [Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5 mg)] on lung function, asthma control, Health Outcomes including the child's quality of life as measured by Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the caregiver's quality of life as measured by Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) at selected centers where a valid translation is available.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: montelukast (5mg QD)
• Drug: Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)

Primary Measures

• Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.

Secondary Measures

• Changes from baseline to endpoint of:morning pre-dose FEV1 (Forced expiratory volume) symptom free 24 hour-periods rescue medication-free 24 hour-periods mean evening PEFR

Inclusion criteria:

• Diagnosis of asthma for at least 6 months (per American Thoracic Society [ATS] definition).
• Best forced expiratory volume in one second (FEV1) between 55% and 80% of predicted normal.
• More than or 12% FEV1 reversibility following inhalation of salbutamol.
• Must also be symptomatic on short-acting beta-agonists.
• Must not have used inhaled corticosteroids over the previous month or LTRAs (Leukotriene antagonists)over the previous 2 weeks.

Exclusion criteria:

• Hospital admission for asthma within 3 months prior to Visit 1.
• Sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within two weeks immediately preceding Screening Visit 1.
• Oral or parenteral steroid therapy in the last 12 weeks, or more than 3 courses in the last 6 months.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 14 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00328718

Study ID Number: SAM103848

ClinicalTrials.gov Identifier: NCT00328718

Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica