Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

NCT00328718 | Completed Phase 3

• 1 other identifier: SAM103848
• Study Type: interventional
• Target: 526
• Locations: 6 countries
• Sites: 25

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.

Conditions

Asthma

Keywords

Persistent Asthma; pediatric asthmatic; asthma control

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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

Interventions

montelukast (5mg QD) DRUG

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

Also known as: montelukast (5mg QD)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (26)

GSK Investigational Site

Santa Fe, Santa Fe Province, 3000, Argentina

Location

GSK Investigational Site

Buenos Aires, C1121ABE, Argentina

Location

GSK Investigational Site

Capital Federal-Buenos Aires, C1424BSF, Argentina

Location

GSK Investigational Site

Bogotá, 11001000, Colombia

Location

GSK Investigational Site

Cali, 76001000, Colombia

Location

GSK Investigational Site

Medellín, 05001000, Colombia

Location

GSK Investigational Site

San José, Costa Rica

Location

GSK Investigational Site

Chihuahua City, Chihuahua, 31020, Mexico

Location

GSK Investigational Site

Guadalajara, Jalisco, 44340, Mexico

Location

GSK Investigational Site

Monterrey, Nuevo León, 64460, Mexico

Location

GSK Investigational Site

Mexico City, 03020, Mexico

Location

GSK Investigational Site

Mexico City, 14080, Mexico

Location

GSK Investigational Site

México, 04530, Mexico

Location

GSK Investigational Site

México, 6720, Mexico

Location

GSK Investigational Site

Lima, Lima Province, Lima 1, Peru

Location

GSK Investigational Site

Lima, Lima Province, Lima 27, Peru

Location

GSK Investigational Site

Adana, 1330, Turkey (Türkiye)

Location

GSK Investigational Site

Ankara, 6100, Turkey (Türkiye)

Location

GSK Investigational Site

Antalya, 7070, Turkey (Türkiye)

Location

GSK Investigational Site

Bursa, 16059, Turkey (Türkiye)

Location

GSK Investigational Site

Istanbul, 34303, Turkey (Türkiye)

Location

GSK Investigational Site

Istanbul, 34668, Turkey (Türkiye)

Location

GSK Investigational Site

Izmir, 35100, Turkey (Türkiye)

Location

GSK Investigational Site

Caracas, 1010, Venezuela

Location

GSK Investigational Site

Caracas, 1060, Venezuela

Location

GSK Investigational Site

Caracas, 1080, Venezuela

Location

Related Publications (1)

• 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.

  PMID: 18803991 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

montelukast; Salmeterol Xinafoate; BID protein, human

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2006
• First Posted: May 22, 2006
• Study Start: October 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

ME (7); CO (3); TU (7); AR (3); VE (3); PE (2)