Clinical trial NCT00328718: Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets
Official title: Randomised, Double-blind, Double-dummy, Parallel-group, Comparative Study of Salmeterol/FP 50/100mcg bd Inhalation Powder Via Diskus With Oral Montelukast (5mg QD) Chewable Tablets in Children 6-14 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Persistent Asthma
pediatric asthmatic
asthma control
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-22
Enrollment: 526
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Capital Federal-Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Santa Fe
country: Argentina
facility: GSK Investigational Site
city: Bogota
country: Colombia
facility: GSK Investigational Site
city: Cali
country: Colombia
facility: GSK Investigational Site
city: Medellin
country: Colombia
facility: GSK Investigational Site
city: San Jose
country: Costa Rica
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Chihuahua
country: Mexico
facility: GSK Investigational Site
city: Mexico D.F.
country: Mexico
facility: GSK Investigational Site
city: Mexico D.F.
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Adana
country: Turkey
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
city: Antalya
country: Turkey
facility: GSK Investigational Site
city: Bursa
country: Turkey
facility: GSK Investigational Site
city: Istanbul
country: Turkey
facility: GSK Investigational Site
city: Istanbul
country: Turkey
facility: GSK Investigational Site
city: Izmir
country: Turkey
facility: GSK Investigational Site
city: Caracas
country: Venezuela
facility: GSK Investigational Site
city: Caracas
country: Venezuela
facility: GSK Investigational Site
city: Caracas
country: Venezuela
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Maspero J, Guerra F, Cuevas F, Gutierrez JP, Soto-Ramos M, Anderton S, Mechali D, Chan R, Pedersen S. Efficacy and tolerability of salmeterol/fluticasone propionate versus montelukast in childhood asthma: A prospective, randomized, double-blind, double-dummy, parallel-group study. Clin Ther. 2008 Aug;30(8):1492-504. doi: 10.1016/j.clinthera.2008.07.018.