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临床试验/NCT03300076
NCT03300076已完成不适用

Multicenter, Open-label, Non Interventional, Prospective, Observational Clinical Trial to Assess the Compliance and Quality of Life in Greek Asthmatic Patients

Elpen Pharmaceutical Co. Inc.1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
800
试验地点
1
主要终点
Quality of Life

研究概览

简要总结

A multicenter, open, non-interventional, prospective, clinical observational study on Conformity to Therapy and Quality of Life in Asthma in patients living in Greece

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Quality of Life

时间窗: 6 months

Change in mini AQLQ scale

次要结局

  • Compliance(6 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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