None listed
Conditions
Interventions
Group 1 Type of group
The subjects of this group will start with the powder device of Salmeterol / Fluticasone propionate (50/100 mcg), inhalation twice a day plus a chewable tablet of Montelukast Placebo four times a day. This scheme will be maintained for 12 weeks.
Group name:Group 2 Type of group
The subjects of this group will start with the powder device of Salmeterol / Fluticasone Propionate Placebo, an inhalation twice a day plus a 5 mg Montelukast chewable tablet once a day. This scheme will be maintained for 12 weeks.
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Gender: Male or female. 2. Age: 6-14 years of age. 3. Asthma Rating: Each subject should have: a) A diagnosis of asthma for at least 6 months. b) A medical history of asthma that required the use of bronchodilator medication with short-acting beta agonist during the 3 months prior to Visit 1. c) At least 4 prescriptions of any medication for asthma should have been prescribed in the past 12 months or at least 3 recipes in the last 6 months. d) A VEFi between 55% and 80% of the normal expected in Visit 1. 4. Each subject should have reversible airway disease. 5. Subjects must be able to demonstrate that they can effectively use a DISKUS powder device. 6. Subjects should be able to use a Mini-Wright peak flow meter and perform the spirometry test. 7. The father, mother or legal guardian must give their informed consent. 8. Concurrent Therapy for Asthma: a) Short acting beta-agonist bronchodilators. b) Current medication for asthma: All study subjects should be able to stop short-acting beta agonist bronchodilator medication, at least for 6 hours before the pulmonary function test. c) No other medication for asthma should have been used before the pulmonary function tests
Exclusion criteria
Exclusion criteria: 1. That you recently had a diagnosis of asthma with life-threatening. 2. Stability of asthma: Hospitalization for asthma within 3 months prior to visit 1. 3. Other diseases / abnormalities. 4. Varicella: A subject can not be selected if he currently has chickenpox, if he has been exposed to chickenpox in the last 3 weeks and is non-immune. 5. Drug allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta agonist, sympathomimetic drug, LTRAs, or any therapy with systemic, inhaled or intranasal corticosteroid. 6. Allergy to milk or milk product. 7. Patients on ritonavir treatment. 8. Infections: Infections of the breast, middle ear, oropharynx, upper or lower respiratory tract within two weeks immediately prior to the screening visit I. 9. Pregnancy test: A positive pregnancy test (the pregnancy test will be performed only on fertile, post-menarchal women). 10. Regular therapy with parenteral or oral steroid: in the last 12 weeks or more than 3 courses of steroids in the last 6 months. 11. Subjects that have previously been enrolled in this study. 12. VEFi less than 55% of the expected value 13. Research medications: any use of a research drug within 30 days prior to the screening visit. 14. Questionable validity of consent. 15. Questionable compliance with medications or visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Spirometry and measurement with the Mini-Wright peak flow meter Measure:Change of the morning MEF average from baseline. Timepoints:Day 1 and weeks 2, 4, 8 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1. The percentage change of the VEF1 pre-dose morning: Spirometry and measurement with the Mini-Wright peak flow meter. 2. The change of FEV1 pre-dose morning: Spirometry and measurement with the Mini-Wright peak flow meter. 3. The percentage change of the 24-hour symptom-free periods: Daily chart 4. The percentage change of the periods of 24 hours free of use of rescue medication: Daily record. 5. The change in the average of overnight FEM: Collected in the daily chart of the use of the Mini-Wright peak flow meter. Measure:1. The percentage change of FEV1 pre-dose from baseline to baseline. 2. The change of FEV1 pre-dose in the morning. 3. The percentage change of the 24-hour symptom-free periods. 4. The percentage change of the 24-hour periods free of the use of rescue medication. 5. The change in the average of the overnight FEM. Timepoints:Spirometry: Day 1 and weeks 2, 4, 8 and 12. Measurement with the Mini-Wright peak flow meter: Every day from the start of the treatment until 12 weeks. Daily chart: Every day from the start of treatment until 12 weeks. | — |
Countries
Argentina, Colombia, Costa Rica, Mexico, Peru, Turkey, Venezuela
Outcome results
None listed