Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

GlaxoSmithKline526 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

526

Conditions

Asthma

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 14 Years

Medical Language ↔ Plain English

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.

Locations (26)

GSK Investigational Site

Santa Fe, Santa Fe Province, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Capital Federal-Buenos Aires, Argentina

GSK Investigational Site

Bogotá, Colombia

GSK Investigational Site

Cali, Colombia

GSK Investigational Site

Medellín, Colombia

GSK Investigational Site

San José, Costa Rica

GSK Investigational Site

Chihuahua City, Chihuahua, Mexico

GSK Investigational Site

Guadalajara, Jalisco, Mexico

GSK Investigational Site

Monterrey, Nuevo León, Mexico

...and 16 more locations

Outcomes

Primary Outcomes

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

Secondary Outcomes

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