CLINICAL STUDY, DOUBLE-BLIND AND RANDOMIZED, TO EVALUATE THE EFFECTIVENESS AND SAFETY OF SALBUTAMOL 2MG + AMBROXOL 7.5MG / 5ML (SALBUVENT EXPECTORANT SYRUP) COMPARED WITH SALBUTAMOL 2MG / 5ML IN PATIENTS OF ACUTE BRONCHITIS WITH BRONCHOSPASM
- Conditions
- -J20-J45J45J20
- Registration Number
- PER-086-20
- Lead Sponsor
- aboratorios Elifarma S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 23
•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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>Measure:Change in the score of the Bronchitis Severity Score (BSS)<br>Timepoints:day 0 and 7<br>
- Secondary Outcome Measures
Name Time Method <br>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.<br>Measure:Evaluate the safety of the medicine<br>Timepoints:five days<br>