COMPLliancE and qualiTy of lifE in Asthma (COMPLETE)
Multicenter, Open-label, Non Interventional, Prospective, Observational Clinical Trial to Assess the Compliance and Quality of Life in Greek Asthmatic Patients
研究概览
详细说明
Dry powder devices, available since 1970, have been developed to make inhalation simpler than pMDIs and relieve the need for co-ordination of spraying and inhalation, which is particularly important for patient groups such as the elderly and children. In addition, dry powder devices do not contain propellant gases potentially hostile to the environment as they are activated by inhalation of the patient and do not cause cold sensation upon inhalation.
Today, the combination of inhaled corticosteroid (ICS) and long-acting β2-inducer with an inhaler is the basic treatment for asthma6.
The addition of long-acting β2-inducer (LABA) to a daily inhaled corticosteroid regimen1:
- Improves the symptoms,
- Reduces nightly asthma symptoms,
- Improves pulmonary function,
- Reduces the use of β2-agonists for rapid action,
- Reduces the number of seizures,
- Does not increase the risk of hospitalizations due to asthma,
- Achieves clinical asthma control in more patients, faster and with less ICS than would be required if ICS were administered alone.
The greater effectiveness of combination therapy has led to the development of stable combination inhalers that both glucocorticosteroids and LABA (eg, fluticasone-salmeterol, budesonide-formoterol stable compounds) are concomitantly conveyed.
Stable combinations are more user-friendly for patients, potentially increasing compliance, and ensure that LABA is always accompanied by glucocorticosteroid1. Of the combinations available, the budesonide-formoterol combination can be used both as maintenance therapy and symptom relief due to the rapid onset of formoterol compared to salmeterol. Both components of the budesonide-formoterol combination when administered are helpful in enhancing protection from severe seizures in patients receiving combination therapy for maintenance and improve the control of asthma at relatively low ICS doses.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Athens、希腊
- Sotiria Pulmonary Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Male or female asthma patients over 18 years of age
- Compliance with treatment
- Compliance with study procedures
- Signed informed consent form
Patients not satisfactorily controlled with inhaled corticosteroids and the use of inhaled short-acting β2-primers or patients already adequately controlled with both inhaled corticosteroids and long-acting β2-stimulants:
- Patients receiving ICS inhaled and SABA invoked
- Patients receiving inhaled ICS and LABA with separate devices each
- Patients receiving periodic and not continuously stable combination of ICS and LABA but not being treated for at least 1 month
- Patients who did not receive any treatment and the doctor decides to immediately start the fixed combination of ICS and LABA
Exclusion Criteria:
- Male or female asthma patients under 18 years of age
- Unsigned patient consent
- Non-compliance with treatment
- Non-compliance in study procedures
- COPD patients (at any stage)
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of Life
大体时间:6 months
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Change in mini AQLQ scale
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Compliance
大体时间:6 months
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Change in MMAS-8 scale
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6 months
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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