None listed
Conditions
Interventions
SALBUVENT EXPECTORANT SYRUP Type of group
Acute and chronic respiratory diseases that present with retention of secretions and bronchospasm that has an infectious etiology or not, treatment of asthma of bronchial asthma, of acute and chronic bronchitis, of pulmonary emphysema, of bronchiestasias and obstructive pulmonary disease.
Pharmaceutical form: Syrup
Dosage and frequency, duration of treatment: Children from 2 to 5 years: Take 3 mL every 8 hours. Children older than 6 years and adults: Take 5 mL every 8 hours (5mL correspo
Acute and chronic respiratory diseases that present with retention of secretions and bronchospasm that has an infectious etiology or not, treatment of asthma of bronchial asthma, of acute and chronic bronchitis, of pulmonary emphysema, of bronchiestasias and obstructive pulmonary disease.
Pharmaceutical form: Syrup
Dosage and frequency: Children 2 to 5 years: Take 3 mL every 8 hours. Children older than 6 years and adults: Take 5 mL every 8 hours
Route of administration: Oral route
Sponsors
Laboratorios Elifarma S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: •Participants between 2 to 17 years of age receiving a prescription for treatment of SOBA and / or Acute Bronchitis with bronchospasm. • Be able to understand, sign and date an informed consent / informed consent / parental consent document (where applicable) according to the guidelines of good clinical practice and local regulations. • Commitment to comply with the assigned treatment and tests. • Desire to adhere to the treatment and follow-up program.
Exclusion criteria
Exclusion criteria: • Children under 2 years old • Treatment with drugs of similar therapeutic action • Cardiovascular diseases such as angina pectoris, arrhythmias, heart failure, coronary heart failure, degenerative heart diseases • Hypersensitivity to Salbutamol • Hypersensitivity to Ambroxol • Hypersensitivity to any of the excipients of the products • Pregnant and / or lactating patients. • Arterial hypertension • Cerebrovascular disease • Mellitus diabetes • Hyperthyroidism • Ketoacidosis; pheochromocytoma • Active gastric ulcer • Parkinson´s disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:the use of SALBUTAMOL 2MG + AMBROXOL 7.5MG / 5ML (SALBUVENT® EXPECTORANTE Syrup) is equal to or greater than that of the use of SALBUTAMOL 2MG / 5ML IN PATIENTS FOR THE TREATMENT of acute bronchitis with bronchospasm. Measure:Change in the score of the Bronchitis Severity Score (BSS) Timepoints:day 0 and 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:evaluate the safety of SALBUTAMOL 2MG + AMBROXOL 7.5MG / 5ML (SALBUVENT® EXPECTORANTE SYRUP) in the treatment of SOBA and / or acute bronchitis with bronchospasm by determining the presentation of adverse effects during treatment. Measure:Evaluate the safety of the medicine Timepoints:five days | — |
Countries
Peru
Contacts
Public ContactRaul Yepez
PERUVIAN CLINICAL RESEARCH S.A.C
Outcome results
None listed