Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00328718
First received: May 19, 2006
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: montelukast (5mg QD)
Drug: Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Estimated Enrollment: 526
Study Start Date: October 2005
Intervention Details:
    Drug: montelukast (5mg QD) Drug: Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)
    Other Names:
    • Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)
    • montelukast (5mg QD)
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

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328718

Locations
Argentina
GSK Investigational Site
Capital Federal-Buenos Aires, Argentina, C1424BSF
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
GSK Investigational Site
Santa Fe, Argentina, 3000
Colombia
GSK Investigational Site
Bogota, Colombia, 11001000
GSK Investigational Site
Cali, Colombia, 76001000
GSK Investigational Site
Medellin, Colombia, 05001000
Costa Rica
GSK Investigational Site
San Jose, Costa Rica
Mexico
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44340
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64460
GSK Investigational Site
Chihuahua, Mexico, 31020
GSK Investigational Site
Mexico, Mexico, 04530
GSK Investigational Site
Mexico, Mexico, 6720
GSK Investigational Site
Mexico D.F., Mexico, 03020
GSK Investigational Site
Mexico D.F., Mexico, 14080
Peru
GSK Investigational Site
Lima, Peru, Lima 1
GSK Investigational Site
Lima, Peru, Lima 27
Turkey
GSK Investigational Site
Adana, Turkey, 1330
GSK Investigational Site
Ankara, Turkey, 6100
GSK Investigational Site
Antalya, Turkey, 7070
GSK Investigational Site
Bursa, Turkey, 16059
GSK Investigational Site
Istanbul, Turkey, 34303
GSK Investigational Site
Istanbul, Turkey, 34668
GSK Investigational Site
Izmir, Turkey, 35100
Venezuela
GSK Investigational Site
Caracas, Venezuela, 1080
GSK Investigational Site
Caracas, Venezuela, 1010
GSK Investigational Site
Caracas, Venezuela, 1060
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00328718     History of Changes
Other Study ID Numbers: SAM103848
Study First Received: May 19, 2006
Last Updated: November 21, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Mexico: Ministry of Health

Keywords provided by GlaxoSmithKline:
Persistent Asthma
pediatric asthmatic
asthma control

Additional relevant MeSH terms:
Fluticasone
Salmeterol
Montelukast
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014