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Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
montelukast (5mg QD)
Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Persistent Asthma, pediatric asthmatic, asthma control

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome 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

Full Information

First Posted
May 19, 2006
Last Updated
January 19, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00328718
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2005 (Actual)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Persistent Asthma, pediatric asthmatic, asthma control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
526 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
montelukast (5mg QD)
Intervention Type
Drug
Intervention Name(s)
Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)
Other Intervention Name(s)
montelukast (5mg QD)
Primary Outcome Measure Information:
Title
Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Capital Federal-Buenos Aires
ZIP/Postal Code
C1424BSF
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
GSK Investigational Site
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Facility Name
GSK Investigational Site
City
Bogota
ZIP/Postal Code
11001000
Country
Colombia
Facility Name
GSK Investigational Site
City
Cali
ZIP/Postal Code
76001000
Country
Colombia
Facility Name
GSK Investigational Site
City
Medellin
ZIP/Postal Code
05001000
Country
Colombia
Facility Name
GSK Investigational Site
City
San Jose
Country
Costa Rica
Facility Name
GSK Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Facility Name
GSK Investigational Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
GSK Investigational Site
City
Chihuahua
ZIP/Postal Code
31020
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico D.F.
ZIP/Postal Code
03020
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico D.F.
ZIP/Postal Code
14080
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico
ZIP/Postal Code
04530
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico
ZIP/Postal Code
6720
Country
Mexico
Facility Name
GSK Investigational Site
City
Lima
ZIP/Postal Code
Lima 1
Country
Peru
Facility Name
GSK Investigational Site
City
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
GSK Investigational Site
City
Adana
ZIP/Postal Code
1330
Country
Turkey
Facility Name
GSK Investigational Site
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
GSK Investigational Site
City
Antalya
ZIP/Postal Code
7070
Country
Turkey
Facility Name
GSK Investigational Site
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
GSK Investigational Site
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Facility Name
GSK Investigational Site
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
Facility Name
GSK Investigational Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
GSK Investigational Site
City
Caracas
ZIP/Postal Code
1010
Country
Venezuela
Facility Name
GSK Investigational Site
City
Caracas
ZIP/Postal Code
1060
Country
Venezuela
Facility Name
GSK Investigational Site
City
Caracas
ZIP/Postal Code
1080
Country
Venezuela

12. IPD Sharing Statement

Citations:
PubMed Identifier
18803991
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.
Results Reference
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Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

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