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Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

NCT ID: NCT00328718

Last Updated: 2017-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-04-30

Brief Summary

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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.

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A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS

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Detailed Description

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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

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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montelukast (5mg QD)

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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montelukast (5mg QD)

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Santa Fe, Santa Fe Province, Argentina

Site Status

GSK Investigational Site

Buenos Aires, , Argentina

Site Status

GSK Investigational Site

Capital Federal-Buenos Aires, , Argentina

Site Status

GSK Investigational Site

Bogotá, , Colombia

Site Status

GSK Investigational Site

Cali, , Colombia

Site Status

GSK Investigational Site

Medellín, , Colombia

Site Status

GSK Investigational Site

San José, , Costa Rica

Site Status

GSK Investigational Site

Chihuahua City, Chihuahua, Mexico

Site Status

GSK Investigational Site

Guadalajara, Jalisco, Mexico

Site Status

GSK Investigational Site

Monterrey, Nuevo León, Mexico

Site Status

GSK Investigational Site

Mexico City, , Mexico

Site Status

GSK Investigational Site

Mexico City, , Mexico

Site Status

GSK Investigational Site

México, , Mexico

Site Status

GSK Investigational Site

México, , Mexico

Site Status

GSK Investigational Site

Lima, Lima Province, Peru

Site Status

GSK Investigational Site

Lima, Lima Province, Peru

Site Status

GSK Investigational Site

Adana, , Turkey (Türkiye)

Site Status

GSK Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

GSK Investigational Site

Antalya, , Turkey (Türkiye)

Site Status

GSK Investigational Site

Bursa, , Turkey (Türkiye)

Site Status

GSK Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

GSK Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

GSK Investigational Site

Izmir, , Turkey (Türkiye)

Site Status

GSK Investigational Site

Caracas, , Venezuela

Site Status

GSK Investigational Site

Caracas, , Venezuela

Site Status

GSK Investigational Site

Caracas, , Venezuela

Site Status

Countries

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Argentina Colombia Costa Rica Mexico Peru Turkey (Türkiye) Venezuela

References

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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.

Reference Type BACKGROUND
PMID: 18803991 (View on PubMed)

Other Identifiers

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SAM103848

Identifier Type: -

Identifier Source: org_study_id

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