CLINICAL TRIAL, DOUBLE-BLIND, RANDOMIZED, THREE-ARMED TRIAL TO EVALUATE THE EFFECTIVENESS AND SAFETY OF A FIXED COMBINATION OF CLENBUTEROL + AMBROXOL (CLENBUVENT® EXPECTORANT 0.005mg + 7, 5mg/mL ORAL SOLUTION) IN COMPARISON WITH AMBROXOL (7.5mg/mL ORAL SOLUTION) AND IN COMPARISON WITH SALBUTAMOL (2mg/5mL SYRUP) IN PEDIATRIC PATIENTS WITH ACUTE BRONCHITIS AND LOWER AIRWAY OBSTRUCTION.

Phase 3

• Conditions: J209 Acute bronchitis, unspecified; Acute bronchitis, unspecified; J209

• Registration Number: PER-041-22
• Lead Sponsor: ABORATORIOS ELIFARMA S A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-29
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: In enrollment
• Sex: All
• Target Recruitment: 4

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a disminucion del puntaje de la escala BSS-ped, por debajo de 3 puntos al final del tratamiento.<br> NAME OF THE RESULT: The resolution of the severity of symptoms of acute bronchitis.<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: Day 0, 4 and 7 of the study.