A Randomized, Double-blinded Clinical Trial Comparing the Efficacy of Antibiotic or Inhaled Corticosteroid to Placebo in Children´s Protracted Cough
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
Prolonged cough lasting more than four weeks is common in children, but the best treatment is often unclear when no underlying disease can be found. This study aims to find out whether commonly used treatments help children with prolonged cough more effectively than placebo.
Children who take part will first undergo standard medical examinations, including lung function tests and a chest X-ray, to look for the cause of the cough. If no specific cause is found, the child may enter the study.
Children with a dry cough will be randomly assigned to receive either an inhaled corticosteroid (fluticasone) or a placebo inhaler for two months. Children with a wet or productive cough will be randomly assigned to receive either an oral antibiotic (amoxicillin-clavulanic acid) or a placebo medicine for 14 days. Neither the families nor the researchers will know which treatment the child receives during the study.
The main goal is to determine whether these treatments significantly reduce or stop the cough compared with placebo. The results will help improve treatment recommendations for children with prolonged cough and avoid unnecessary medication use.
Participation is voluntary, and parents provide written informed consent for their child.
详细描述
Why is this study being done? A cough that lasts for more than four weeks is common in children and can be distressing for both the child and their family. In many cases, careful medical examinations do not reveal a clear underlying disease that would explain the symptoms. Despite this, children are often treated with medications such as inhaled corticosteroids or antibiotics, even though it is not always clear whether these treatments are truly beneficial.
The aim of this study is to find out whether two commonly used treatments are more effective than placebo in children with prolonged cough when no clear cause can be identified. By doing this, the study seeks to improve future care for children with prolonged cough and reduce unnecessary medication use.
Who is organising the study? The study is conducted by the Pirkanmaa Wellbeing Services County in Finland and led by an experienced paediatric specialist at Tampere University Hospital (TAYS). The research team specialises in children's respiratory diseases and follows national and international clinical research regulations.
Who can take part?
The study includes children who:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prolonged cough lasting continuously for more than 4 weeks
- •No chronic disease requiring continuous medication (i.e. a generally healthy child)
- •No previous physician-diagnosed condition associated with prolonged cough episodes
- •No physician-identified symptoms or findings suggestive of an underlying disease
- •No prior physician-diagnosed allergic reaction or other severe or life-threatening adverse reaction to the investigational medicinal products (fluticasone or amoxicillin-clavulanic acid)
- •No simultaneous participation in another clinical drug trial
- •Parents/guardians have sufficient spoken and written Finnish language proficiency
- •Written, voluntary informed consent provided by a parent or legal guardian
排除标准
- •Children with symptoms or findings suggestive of an underlying cause of cough, including:
- •A previously physician-diagnosed disease associated with prolonged cough
- •Clinical examination or history at the study visit raising suspicion of a disease associated with prolonged cough (positive "cough pointers")
- •Abnormal lung function test
- •Abnormal chest X-ray (peribronchial markings are permitted)
- •Additional exclusion criteria:
- •Prior physician-diagnosed allergic reaction or other severe or life-threatening adverse reaction to the investigational medicinal products
- •Simultaneous participation in another clinical drug trial
- •Prolonged cough that has resolved spontaneously prior to the study visit