Asthma Clinical Trial
Official title:
Randomised, Double-blind, Double-dummy, Parallel-group, Comparative Study of Salmeterol/FP 50/100mcg bd Inhalation Powder Via Diskus With Oral Montelukast (5mg QD) Chewable Tablets in Children 6-14 Years
Verified date | January 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 526 |
Est. completion date | April 2007 |
Est. primary completion date | April 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 14 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Argentina | GSK Investigational Site | Capital Federal-Buenos Aires | |
Argentina | GSK Investigational Site | Ciudad Autónoma de Buenos Aires | |
Argentina | GSK Investigational Site | Santa Fe | |
Colombia | GSK Investigational Site | Bogota | |
Colombia | GSK Investigational Site | Cali | |
Colombia | GSK Investigational Site | Medellin | |
Costa Rica | GSK Investigational Site | San Jose | |
Mexico | GSK Investigational Site | Chihuahua | |
Mexico | GSK Investigational Site | Guadalajara | Jalisco |
Mexico | GSK Investigational Site | Mexico | |
Mexico | GSK Investigational Site | Mexico | |
Mexico | GSK Investigational Site | Mexico D.F. | |
Mexico | GSK Investigational Site | Mexico D.F. | |
Mexico | GSK Investigational Site | Monterrey | Nuevo León |
Peru | GSK Investigational Site | Lima | |
Peru | GSK Investigational Site | Lima | |
Turkey | GSK Investigational Site | Adana | |
Turkey | GSK Investigational Site | Ankara | |
Turkey | GSK Investigational Site | Antalya | |
Turkey | GSK Investigational Site | Bursa | |
Turkey | GSK Investigational Site | Istanbul | |
Turkey | GSK Investigational Site | Istanbul | |
Turkey | GSK Investigational Site | Izmir | |
Venezuela | GSK Investigational Site | Caracas | |
Venezuela | GSK Investigational Site | Caracas | |
Venezuela | GSK Investigational Site | Caracas |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Argentina, Colombia, Costa Rica, Mexico, Peru, Turkey, Venezuela,
Maspero J, Frances Guerra F, Cuevas F et al. Clin Ther 2008 ; 30(4): 1-13
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint. | |||
Secondary | 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 |
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