PER-041-22招募中3 期
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.
ABORATORIOS ELIFARMA S A0 个研究点目标入组 4 人开始时间: 2023年12月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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).
研究者
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