Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
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, MD, 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: 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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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
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 Clinical Trial Call Center, Buenos Aires, Argentina
GSK Clinical Trial Call Center, Santa Fe, Argentina
GSK Clinical Trial Call Center, Bogota, Colombia
GSK Clinical Trial Call Center, Medellin, Colombia
GSK Clinical Trial Call Center, Cali, Colombia
GSK Clinical Trial Call Center, San Jose, Costa Rica
GSK Clinical Trial Call Center, Quito, Ecuador
GSK Clinical Trial Call Center, Guayaquil, Ecuador
GSK Clinical Trial Call Center, Guadalajara, Mexico
GSK Clinical Trial Call Center, Ciudad de Mexico, Mexico
GSK Clinical Trial Call Center, Chihuahua, Mexico
GSK Clinical Trial Call Center, Monterrey, Mexico
GSK Clinical Trial Call Center, Lima, Peru
GSK Clinical Trial Call Center, Lima, Peru
GSK Clinical Trial Call Center, Instambul, Turkey
GSK Clinical Trial Call Center, Izmar, Turkey
GSK Clinical Trial Call Center, Adana, Turkey
GSK Clinical Trial Call Center, Ankara, Turkey
GSK Clinical Trial Call Center, Antalya, Turkey
GSK Clinical Trial Call Center, Bursa, Turkey
GSK Clinical Trial Call Center, Caracas, Venezuela
GSK Clinical Trial Call Center, Caracas, Venezuela
Additional Information
Starting date: October 2005
Last updated: November 9, 2007
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