Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00328718

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Montelukast sodium Montelukast

U.S. FDA Resources

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

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

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
Medellin, Colombia, 05001000
GSK Investigational Site
Bogota, Colombia, 11001000
GSK Investigational Site
Cali, Colombia, 76001000
Costa Rica
GSK Investigational Site
San Jose, Costa Rica
Ecuador
GSK Investigational Site
Guayaquil, Ecuador, EC090150
Mexico
GSK Investigational Site
Mexico D.f., Mexico, 14080
GSK Investigational Site
Mexico, Mexico, 6720
GSK Investigational Site
Chihuahua, Mexico, 31020
GSK Investigational Site
Mexico D.f., Mexico, 03020
GSK Investigational Site
Mexico, Mexico, 04530
Mexico, Jalisco
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44340
Mexico, Nuevo León
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64460
Peru
GSK Investigational Site
Lima, Peru, Lima 27
GSK Investigational Site
Lima, Peru, Lima 1
Turkey
GSK Investigational Site
Istanbul, Turkey, 34303
GSK Investigational Site
Ankara, Turkey, 6100
GSK Investigational Site
Izmir, Turkey, 35100
GSK Investigational Site
Istanbul, Turkey, 34668
GSK Investigational Site
Antalya, Turkey, 7070
GSK Investigational Site
Bursa, Turkey, 16059
GSK Investigational Site
Adana, Turkey, 1330
Venezuela
GSK Investigational Site
Caracas, Venezuela, 1010
GSK Investigational Site
Caracas, Venezuela, 1060
GSK Investigational Site
Caracas, Venezuela, 1080

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SAM103848, PEACE
Study First Received:	May 19, 2006
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00328718 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Mexico: Ministry of Health

Keywords provided by GlaxoSmithKline:

Persistent Asthma
asthma control
pediatric asthmatic

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic Agonists
Leukotriene Antagonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses

Fluticasone
Dermatologic Agents
Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Montelukast
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 08, 2010