None listed
Conditions
Interventions
In patients 2 to 5 years of age, the daily dose will be the 4 mg chewable tablet administered once a day, at night, at bedtime, regardless of food. For patients> 6 years of age, the daily dose will be the 5 mg chewable tablet administered once a day, at night, at bedtime, regardless of food.
Group name:Inhaled Cromolin Type of group
usual care (cromolyn inhaled / nebulized or inhaled corticosteroids / nebulized). Once therapy has begun, it should be maintained as a constant daily dose throughout the extension period.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient arrived satisfactorily until Visit 24 of Protocol 072-11. • The parent / legal guardian accepts the patient´s participation in the study as indicated by the signature of the parent / legal guardian on the consent form. The patient and the parent / guardian are willing to comply with the procedures and both the patient and the parent / guardian can make the scheduled clinical visits.
Exclusion criteria
Exclusion criteria: • The consent of the parent or guardian can not be obtained. • The patient is hospitalized. • The patient suffered a serious or adverse clinically important experience that is still present at Visit 24 of Protocol 072-11. • The patient experiences significant changes from the clinical point of view in his general medical condition since he enrolled in Protocol 072-11.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Physical exam including neurological exam Vital signs Blood Biochemistry BUN (nitrogen of blood urea) Creatinine Total bilirubin SGOT (glutamic oxaloacetic serum transaminase) (AST) SGPT (serum pyruvate glutamic transaminase) (ALT) Alkaline phosphatase Glucose Sodium Potassium Chloride Baking soda Calcium Phosphate Measure:Safety Timepoints:Visits 26, 28 y 30 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed