Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: montelukast (5mg QD) (Drug); Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: See Detailed Description
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.
Secondary outcome: 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
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
Minimum age: 6 Years.
Maximum age: 14 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Investigational Site, Capital Federal-Buenos Aires C1424BSF, Argentina
GSK Investigational Site, Ciudad Autónoma de Buenos Aires C1121ABE, Argentina
GSK Investigational Site, Santa Fe 3000, Argentina
GSK Investigational Site, Bogota 11001000, Colombia
GSK Investigational Site, Cali 76001000, Colombia
GSK Investigational Site, Medellin 05001000, Colombia
GSK Investigational Site, San Jose, Costa Rica
GSK Investigational Site, Chihuahua 31020, Mexico
GSK Investigational Site, Mexico D.F. 03020, Mexico
GSK Investigational Site, Mexico D.F. 14080, Mexico
GSK Investigational Site, Mexico 6720, Mexico
GSK Investigational Site, Mexico 04530, Mexico
GSK Investigational Site, Lima Lima 1, Peru
GSK Investigational Site, Lima Lima 27, Peru
GSK Investigational Site, Adana 1330, Turkey
GSK Investigational Site, Ankara 6100, Turkey
GSK Investigational Site, Antalya 7070, Turkey
GSK Investigational Site, Bursa 16059, Turkey
GSK Investigational Site, Istanbul 34303, Turkey
GSK Investigational Site, Istanbul 34668, Turkey
GSK Investigational Site, Izmir 35100, Turkey
GSK Investigational Site, Caracas 1010, Venezuela
GSK Investigational Site, Caracas 1060, Venezuela
GSK Investigational Site, Caracas 1080, Venezuela
GSK Investigational Site, Guadalajara, Jalisco 44340, Mexico
GSK Investigational Site, Monterrey, Nuevo León 64460, Mexico
Additional Information
Related publications: Maspero J, Frances Guerra F, Cuevas F et al. Clin Ther 2008 ; 30(4): 1-13
Starting date: October 2005
Last updated: November 21, 2012
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