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

Sponsored by:	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

MedlinePlus related topics: Asthma

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

U.S. FDA Resources

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

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

Show 32 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SAM103848, PEACE
Study First Received:	May 19, 2006
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00328718
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

Study placed in the following topic categories:

Montelukast
Hypersensitivity
Lung Diseases, Obstructive
Salmeterol
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Fluticasone
Asthma
Leukotriene Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Immune System Diseases
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Anti-Allergic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009