Prospective, Parallel-group, Randomized Study to Evaluate the Compliance to the Treatment of Children Aged Between 6 and 14 Years Old With Persistent Moderate or Severe Asthma, Receiving the Association Fluticasone 250 mcg/Dose and Salmeterol 50 mcg/Dose Twice a Day. ADERE PROJECT
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 472
- 主要终点
- The main outcome, compliance, is being measured by the number of doses used of the drug salmeterol combined with fluticasone (Seretide Diskus) divided by the number of doses foreseen for the time considered.
研究概览
简要总结
Prospective, parallel-group, randomized study to evaluate the compliance to the treatment of children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving the association Fluticasone 250 mcg/dose and Salmeterol 50 mcg/dose twice a day.
ADERE PROJECT (Pediatric)
详细描述
Objectives
General:
To evaluate the compliance degree to the treatment of asthmatic children, according to the attention received.
Specific:
- To study asthmatic compliance to the treatment proposed, aiming at an association with other factors, such as: parents' instruction, hospitalizations, personal and family history of atopy, co-morbidities, severity of the disease and use of other drugs.
- To study asthmatic compliance to the treatment proposed, associating it with the impact in quality of life, though the application of a specific questionnaire.
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
- None
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signature of a informed consent form
- •Age between 6 and 14 years old
- •Diagnosis of persistent moderate or severe asthma, according to III Brazilian Consensus on Asthma Management.
- •Home telephone available
排除标准
- •Co-morbidities that may interfere with the study evaluation or that require continuous drugs, e.g., cardiopathy, gastro-esophageal reflux or diabetes.
- •Continuous systemic corticosteroid use for more than seven days
- •The patient has been treated or is being treated with allergen-specific immunetherapy
研究组 & 干预措施
telephone follow-up
Asthmatic children being treated, who will be given medical guidance and therapeutic guidance through telephone calls at every fifteen days to the parents or guardians, performed by trained professionals.
干预措施: Telephone follow-up (Other)
No telephone follow-up
Asthmatic children being treated, who will be given medical guidance without telephone follow-up calls to parents or guardians.
干预措施: No telephone follow-up (Other)
结局指标
主要结局
The main outcome, compliance, is being measured by the number of doses used of the drug salmeterol combined with fluticasone (Seretide Diskus) divided by the number of doses foreseen for the time considered.
时间窗: After 90 days of treatment
次要结局
- Regular medical attention sought, evaluated by information in the questionnaires(After 90 days of treatment)
- Increase in the use of rescue drug(After 90 days of treatment)
- Disease control, evaluated by information in the questionnaires.(After 90 days of treatment)
- Improvement in the quality of life.(After 90 days of treatment)
- Increase in the weekly number of nocturnal awakening or the number of awakenings per night(After 90 days of treatment)
- Additional resources in the event of attacks(After 90 days of treatment)