None listed
Conditions
Interventions
GROUP 1 Type of group
Period I: This group will be treated with Montelukast Placebo PO QD for 3 weeks + Fluticasone Propionate Placebo, inhalations BID for 3 weeks.
Period II: This group will be treated with Montelukast 10 mg PO QD for 6 months + Fluticasone Propionate Placebo, inhalations BID for 6 months.
Group name:GROUP 3 Type of group
Period I: This group will be treated with Montelukast Placebo PO QD for 3 weeks Fluticasone Propionate Placebo, 1 inhalation BID for 3 weeks.
Period II: This group will be treated with Montelukast Placebo PO QD for 6 months Fluticasona Propionate Placebo, 1 inhalation BID for 6 months.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient understands the study procedures and agrees to participate by signing the corresponding informed consent form. 2. The patient is a man or woman> 18 to <55 years of age 3. Female patients must have a level of B-hCG in urine consistent with non-pregnant status in Visit 1. Patients agree to use appropriate contraceptives at least 30 days before their first study visit and continue using them for at least 14 days after Visit 5 or discontinuation visit. 4. The patient presents all the signs and symptoms consistent with the diagnosis of asthma in Visit 1. 5. Smokers with a smoking history of 30 packs-year or less. 6. The patient agrees not to change their usual consumption of caffeinated beverages during the entire study. 7. It is considered that the patient is in good health and stable in the physical and mental.
Exclusion criteria
Exclusion criteria: 1. The patient is mentally or legally disabled, which prevents obtaining informed consent. 2. The patient is hospitalized. 3. The patient is a woman who is pregnant or has <8 weeks postpartum or is breastfeeding. 4. The patient intends to move or go on vacation for a period of time that would prevent their participation in the study. 5. The patient has undergone a major surgery procedure within four weeks of Visit 1. 6. The patient has participated in a clinical trial that involves the use of a research drug or marketed within four weeks of Visit 1. 7. The patient is currently a habitual user of drugs or alcohol or has a recent history, within the last 5 years, of illicit drug abuse or recent alcohol abuse. 8. The patient has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD). 9. The patient has ever been intubated due to asthma, has required acute therapy for asthma administered in an emergency room / urgent care facility / office within one month or has been hospitalized for asthma within three months of the Visit 1. 10. The patient suffers, in addition to asthma, some active, acute or chronic lung disorder documented by history, physical examination or a chest x-ray. 11. The patient presents with symptoms and unresolved signs of an upper respiratory tract infection (URI) within 3 weeks of Visit 1. 12. The patient presents evidence of an active sinus infection and clinically significant. 13. The patient has a recent history of a clinically significant psychiatric disorder. 14. The patient has a history of anaphylactic allergic reaction related to the administration of either a commercially available or investigational drug or otherwise has hypersensitivity to montelukast sodium, fluticasone propionate or salbutamol or any of these components drugs. 15. The patient suffers from an active gastrointestinal disease, cardiovascular, hepatic, neurological, renal, genitourinary or hematologic clinically significant. 16. The patient has uncontrolled hypertension. 17. The patient has a history of a disease that will require treatment with an excluded medication. 18. Patients known to be HIV positive. 19. Cancer within the last 5 years. 20. The patient has received some of the prohibited drugs before Visit 1. 22. The patient has initiated immunotherapy within 6 months prior to the Pre-selection visit and / or it is expected that the dose of the same will change during the course of the study. 23. The patient is not able to perform acceptable and reproducible spirometry or FEFR measurements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation. Daily reports of the patient. Measure:Percentage of days of asthma control. Timepoints:Days 1, 30, 90 and 180. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Daily reports of the patient. Measurement of the PEFR with maximum flow meter. Measure:Average change with respect to the baseline average score of daytime symptoms. Change with respect to the baseline of the average maximum expiratory flow rate AM (PEFR). Timepoints:Days 1, 30, 90 and 180. ; Outcome name:Clinical evaluation Daily reports of the patient. Measurement of the PEFR with maximum flow meter. Spirometry test. Laboratory test of eosinophils. Measure:Change with respect to the baseline of the average score of nocturnal symptoms of asthma. Change with respect to baseline of the average PEFR PM. Percentage change with respect to the baseline of the average daily number of inhalations with a B-agonist. Percentage of days without asthma. Percentage of patients with asthma attacks. Percentage change with respect to baseline FEV1. Discontinuation due to asthma. Change in the baseline eosinophil count. Timepoints:Clinical evaluation, diaries of patient reports, PEFR measurement with maximum flow meter: Days 1, 30, 90 and 180. Spirometry test: Days 1, 90 and 180. Laboratory test of eosinophils: Days 90 and 180. ; Outcome name:Physical exam. Measurement of the PEFR with maximum flow meter. Report of adverse events in diaries of patient reports. Measure:Safety of the treatment. Timepoints:Days 1, 30, 90 and 180. | — |
Countries
India, Peru
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed