Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328718
• Other study ID #: SAM103848
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2006
• Last updated: January 19, 2017
• Start date: October 2005
• Est. completion date: April 2007

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• montelukast (5mg QD)

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

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Capital Federal-Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	Santa Fe
Colombia	GSK Investigational Site	Bogota
Colombia	GSK Investigational Site	Cali
Colombia	GSK Investigational Site	Medellin
Costa Rica	GSK Investigational Site	San Jose
Mexico	GSK Investigational Site	Chihuahua
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Mexico
Mexico	GSK Investigational Site	Mexico
Mexico	GSK Investigational Site	Mexico D.F.
Mexico	GSK Investigational Site	Mexico D.F.
Mexico	GSK Investigational Site	Monterrey	Nuevo León
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Turkey	GSK Investigational Site	Adana
Turkey	GSK Investigational Site	Ankara
Turkey	GSK Investigational Site	Antalya
Turkey	GSK Investigational Site	Bursa
Turkey	GSK Investigational Site	Istanbul
Turkey	GSK Investigational Site	Istanbul
Turkey	GSK Investigational Site	Izmir
Venezuela	GSK Investigational Site	Caracas
Venezuela	GSK Investigational Site	Caracas
Venezuela	GSK Investigational Site	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Argentina,  Colombia,  Costa Rica,  Mexico,  Peru,  Turkey,  Venezuela, 

References & Publications (1)

Maspero J, Frances Guerra F, Cuevas F et al. Clin Ther 2008 ; 30(4): 1-13

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.
Secondary	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