None listed
Conditions
Interventions
4 mg montelukast Type of group
4 mg montelukast will be administered in pediatric patients between 6 and 18 months of age with RSV-induced bronchiolitis.
Group name:placebo Type of group
Montelukast placebo will be administered in pediatric patients between 6 and 18 months of age with bronchiolitis induced by RSV.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a. The patient is a boy or girl> 6 months and <18 months of age at the time of Visit 1. b. The parent / legal guardian (the primary caregiver) accepts the patient´s participation in the study as indicated by the signature of the parent / legal guardian in the consent form. The patient and the parent / guardian are willing to comply with the procedures and can make scheduled clinic visits. c. The parent / legal guardian (the primary caregiver of the child who signed the consent form) will remain constant throughout Period I and Period 13 of the study. d. The patient is considered to be in good health (regardless of their bronchiolitis) based on your medical history, physical examination and data laboratory. e. The patient is within the 5th and 95th percentile of height and weight for their age.
Exclusion criteria
Exclusion criteria: a. The parent / legal guardian is, in the opinion of the investigator, mentally or legally disabled, so it is not possible to obtain informed consent. b. The patient and / or the parent / legal guardian intends to move out or leave on vacation away from home for more than 16 days during Period I and / or Period II of the study. c. The patient has participated in a clinical trial of an investigational or commercial drug within 4 weeks prior to Visit 1. d. The patient has undergone a major surgical procedure within 4 weeks prior to Visit 1. e. The patient is allergic to apples or applesauce. f. The patient is in a situation (for example, in the care of an unreliable surrogate family, moving) or has a condition that, in the opinion of the investigator, could interfere with their optimal participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage of Symptom-free days (Percent of Cough-free days will be analyzed as a component of the Percentage of symptom-free days). Measure:Montelukast (at a dose of 4 mg and 8 mg in combination), compared to placebo, results in an improvement of respiratory symptoms during a 4-week treatment period in pediatric patients 6 to 18 months of age with RSV-induced bronchiolitis. Timepoints:at week 2, 4, 9, 14, 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage of Patients with Exacerbations and Percentage of Days Without Bronchiolitis. Measure:Percentage of Patients with Exacerbations and Percentage of Days Without Bronchiolitis. Timepoints:at week 2, 4, 9, 14, 24 | — |
Countries
Argentina, Australia, Austria, Bahrain, Belgium, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Guayana, Honduras, Hungary, Iceland, Ireland, Italy, Jamaica, Latovia, Lebano, Lithuania, Luxembourg, Macedonia, Malasya, Mexico, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad&Tobago, Turkey, Ukraine, United Kindgdom, United States, Venezuela, Yugoslavia
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed