Status:
COMPLETED
Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
6-14 years
Phase:
PHASE3
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-...
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 (50/10...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT00328718
Start Date
October 1 2005
End Date
April 1 2007
Last Update
January 20 2017
Active Locations (26)
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1
GSK Investigational Site
Santa Fe, Santa Fe Province, Argentina, 3000
2
GSK Investigational Site
Buenos Aires, Argentina, C1121ABE
3
GSK Investigational Site
Capital Federal-Buenos Aires, Argentina, C1424BSF
4
GSK Investigational Site
Bogotá, Colombia, 11001000