J209 Acute bronchitis, unspecified Acute bronchitis, unspecified
Conditions
Interventions
Products:
* Clenbuvent® Expectorant (0.005 mg of clenbuterol + 7.5 mg/mL of ambroxol), Oral solution. 100ml bottle.
Posology:
- From 2 to 4 years: 1.5 mL twice a day for 7 days.
- From 5 to 6 years: 2
Sponsors
LABORATORIOS ELIFARMA S A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Boys and girls between 2 and 6 years old. 3. Signed informed consent form. 4. Parents or legal representatives in the capacity to understand, sign and date an informed consent document according to the guidelines of good clinical practices and local regulations. 5. Parents or legal representatives with a commitment to comply with the assigned treatment and tests. 6. Parents or legal representatives wishing to join the treatment and follow-up program. 2. Clinical diagnosis of acute bronchitis with bronchial obstruction, complying with the BSSped scale <=10.
Exclusion criteria
Exclusion criteria: 17. Concurrent treatment with antibiotics, bronchodilators (ß2 agonists), corticosteroids, or beta-blockers. 4. Comorbidities: severe hyperthyroidism, tachycardia, arrhythmias, heart conditions, hypertrophic obstructive cardiomyopathy, and in cases of pheochromocytoma. 1. Clenbuterol allergy. 2. Allergy to Ambroxol. 3. Allergy to Salbutamol. 5. Concomitant respiratory infections such as acute otitis media, acute sinusitis, pharyngotonsillitis, pneumonia, subpharyngeal infections or tonsillar abscesses. 6. Bronchial asthma. 7. Oxygen saturation =92% (from 0 to 2500 masl), =85% (above 2500 masl) or cyanosis 8. Under 2 years old or over 6 years old. 9. Respiratory difficulty: severe or very severe dyspnea, retractions, grunting, nasal flaring, apnea. Bad general state. 10. Oral intolerance. 11. Caregiver (mother, father, family member, or other person caring for the child) unable to provide appropriate observation or comply with prescribed home therapy 12. Difficult accessibility to the health facility. 13. Use of antibiotics in the previous two weeks. 14. Hospitalization for any reason in the previous two weeks. 15. Skin rash. 16. History of recurrent or recent bronchitis (more than 3 episodes in the last 6 months or 1 episode in the last month).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| La disminucion del puntaje de la escala BSS-ped, por debajo de 3 puntos al final del tratamiento. NAME OF THE RESULT: The resolution of the severity of symptoms of acute bronchitis. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 0, 4 and 7 of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical evaluation. NAME OF THE RESULT: Absence of wheezing on day 4 after starting treatment. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 4 ;Detection of adverse events by clinical evaluation NAME OF THE RESULT: Frequency of adverse events in each treatment group. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Until 7 days after finishing the treatment (day 14). ;La disminucion del puntaje de la escala BSS-ped, por debajo de 3 puntos al final del tratamiento. NAME OF THE RESULT: The resolution of the severity of symptoms of acute bronchitis. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 0, 4 and 7 of the study. ;The change in the score obtained in each of the symptoms of the BSS-ped scale. NAME OF THE RESULT: The resolution of the severity of each of the symptoms that are evaluated in the BSS-ped scale. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 0, 4 and 7 of the study. ;Number of patients requiring salbutamol rescue. It will be determined by clinical evaluation. NAME OF THE RESULT: Need for rescue therapy with Salbutamol Inhaler PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 3 | — |
Countries
Peru
Contacts
Public ContactRAUL FLORENTINO HERNAN YEPEZ
LABORATORIOS ELIFARMA S A
Outcome results
None listed