None listed
Conditions
Interventions
Group 1 Type of group
Patients will receive a 5 mg montelukast chewable tablet + fluticasone placebo inhaled daily for 12 months
Group name:Group 2 Type of group
inhaled fluticasone of 100 mcg (2 shots) taken twice daily + montelukast placebo for 12 months
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is male or female and is at least 6 years old and not more than 14 years old at Visit 1. • The patient has mild persistent asthma at step 2 of the GINA guidelines which is defined as the symptoms in the 3 months prior to the Study at least once a week, but less than once a day, every day. • The asthma treatment currently includes the use of a short-acting inhaled b-agonist OR a control medication and the use of a short-acting inhaled b-agonist. • The patient complies with all the signs and symptoms of asthma in Visit 3 • The patient is able to chew the tablet. • The patient is considered to have a good and stable physical and mental health status (except for his asthma) based on medical history, physical examination and routine laboratory information, and is apparently able to successfully complete this Study.
Exclusion criteria
Exclusion criteria: • The parent / legal guardian, in the opinion of the investigator, is mentally or legally incapacitated, which prevents informed consent from being obtained, or unable to read or understand the written material. • The patient, in the opinion of the investigator, is mentally or legally incapacitated, which prevents informed consent from being obtained. • The patient is hospitalized. • The patient intends to move from home or go on vacation for periods of time that would prevent their participation in the study. • The patient has undergone a major surgery procedure within four weeks prior to Visit 1. • The patient has participated in a clinical trial involving an experimental or commercialized drug within four weeks prior to Visit 1. • The patient, in addition to asthma, suffers from active, acute or chronic pulmonary disorders documented in his or her history or physical examination. • The patient has ever been intubated for asthma, has required therapy for the treatment of acute asthma in an emergency room / urgent care / office within the month prior to visit 1 or has been hospitalized for asthma within three months prior to Visit 1. • The patient has unresolved symptoms and signs of upper respiratory tract infection (TRS) within three weeks prior to Visit 1 or during the onset period. • The patient presents evidence of active, clinically significant sinus infection within the week of Visit 1 or during the transition period. • The patient has a history of an anaphylactic allergic reaction that is related to the administration of a commercialized or investigational drug, or is otherwise hypersensitive to inhaled P-agonists, inhaled fluticasone, oral montelukast, or corticosteroids oral or its components. • The patient has a clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurological, genitourinary or hematological systems or has uncontrolled hypertension (> 160/95) or has immunodeficiency or an autoimmune disorder. • The patient has a history of any disease that would require treatment with an excluded medicine, which could represent an immediate threat to his life (ventricular arrhythmia, neoplasia, not fully cured or treated in the last three months, ´labile´ diabetes mellitus), it would represent a restriction on the participation or satisfactory completion of the study, or it would constitute an additional risk for the patient when the study drug is administered. • The patient has significant or unexplained abnormalities in baseline laboratory measurements. • The patient is a woman of childbearing age and has a positive BhCG ​​in urine during the transition period before randomization • The patient has taken the following medications: 1) Oral corticosteroids, intravenous, rectified | intramuscular or intraarticular within the month of Visit 1. 2) Antibiotics for> 7 consecutive days during the 4 weeks prior to Visit 1 or during Period 1. Anthobiotic therapy will be allowed in Period 11. 3) Gamma globulin or immunosuppressants administered intravenously within the month prior to Visit 1. 4) B-receptor blocking agents (including eye preparations) in individuals known to be sensitive to these components, during the two weeks prior to Visit 1. 5) Aspirin and non-steroidal anti-inflammatory drug in patients known to be sensitive to them, during the two weeks prior to Visit 1. • The patient has taken any anti-asthmatic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:One day without the use of rescue b-agonists, evaluated on the Daily Patient Record Card, without additional medications for asthma Measure:Percentage of days without rescue medication for asthma during the 12-month double-blind treatment period Timepoints:12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Analyzed as a change in the expected percentage and as a change from the baseline in absolute values. Measure:The forced expiratory volume pre and post bronchodilator in the first second - FEV1 Timepoints:At each visit of the double blind treatment period ; Outcome name:percentage (%) of patients requiring asthma therapy (excluding the (short-acting b-agonists) in addition to the study medication. Measure:Patients who require additional therapy against asthma Timepoints:At each visit of the double blind treatment period ; Outcome name:Percentage (%) of patients with asthma attacks and the number of asthma attacks. Measure:Asthma attacks Timepoints:At each visit of the double blind treatment period ; Outcome name:Percentage of days on which b-agonists are used as recorded on the Patients Daily Record Card Measure:Use of B-agonists as needed Timepoints:At each visit of the double blind treatment period ; Outcome name:The quality of life of pediatric patients in relation to asthma evaluated by means of a questionnaire in visits 3 and 6 of the double blind treatment period and analyzed as a change from baseline to the last value obtained. Measure:Quality of life of the patient in relation to asthma Timepoints:Visits 3 and 6 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed