Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: montelukast (5mg QD)

Drug: Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00328718

SAM103848

Details and patient eligibility

About

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.

Full description

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

Sex

All

Ages

6 to 14 years old

Volunteers

No Healthy Volunteers

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.