Assessment of Clinical Factors Influencing on Correctness of Inhalation Technique in Adults With Asthma or COPD.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Assessment of correctness of inhalation technique
研究概览
简要总结
Asthma and COPD are common chronic diseases of respiratory system. The correct use of inhalers is crucial in terms of efficacy of the treatment, however both asthma and COPD patients quite frequently misuse the inhalers. The objective of this study is to determine the factors influencing the number of inhalation errors committed by asthma and COPD patients when using the inhalers.
In included patients the inhalation technique will be evaluated (by both list of inhalation errors and 4 point scale of proper inhaling) by two observers and the below information will be collected:
- general demographic information and education level
- information concerning time of diagnosis, the previous course of disease, smoking history, number of previous inhalation techniques training, the sources of information about the inhalation technique and adherence to therapy
- Asthma Control Test or COPD Assessment Test (respectively for asthma and COPD)
- assessment of quality of life (St. George's Questionnaire for COPD and Asthma Quality of Life Questionnaire for asthma)
- cognitive functions assessment using Mini-Mental State Examination
- the simplified assessment of vision impairments
- the results of spirometry
详细描述
Asthma and chronic obstructive pulmonary disease (COPD) are common chronic diseases of respiratory system. Asthma affects about 5% of adults in Poland. The inhaling therapy is the cornerstone of asthma treatment, especially inhaled glucocorticosteroids (ICS). The correct use of inhalers is crucial for efficiency of the therapy and reduction of undesirable side effects of medications. COPD is also a common chronic respiratory disease that affects about 10% of adults above 40 years old. The most important action to prevent and to treat COPD is to stop smoking. The main medications used by COPD patients are inhaled bronchodilators. Both asthma and COPD patients misuse the inhalers.
The objective of this study is to determine the factors influencing the number of inhalation errors committed by asthma and COPD patients when using the inhalers.
Patients:
Patients with asthma or COPD treated in hospital or in out-patient clinic will be asked for participating in the study. Power analysis and sample size calculations indicated that a sample size of 215 subjects (with either asthma or COPD) would provide statistical power to detect even weak correlation (r=0.2) assuming error alpha = 0.05, beta = 0.20 and 10% drop out.
Study design
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent for participating in the study
- •Age 18 -85 years
- •COPD or asthma diagnosed at least 3 months prior to enrolment
- •using of at least one inhaler regularly every day
- •using one of the inhalers: Metered Dose Inhalers (MDI), Dry Powder Inhalers (DPI) or Metered Dose Liquid Inhalers (MDLI)
排除标准
- •Lack of informed consent
- •Age <18 years or > 85 years old
- •Diagnosis of asthma or COPD shorter than 3 months before enrollment
- •Using inhalers unregularly.
- •Symptoms of infection 5 days prior to beginning of the study
结局指标
主要结局
Assessment of correctness of inhalation technique
时间窗: baseline
Assessment of correctness of inhalation technique by list of inhalation errors and 4 point scale of proper inhaling and by two observers
次要结局
- Assessment of vision impairments(baseline)
- Assessment of asthma or COPD duration(baseline)
- Assessment of quality of life related to asthma(baseline)
- Assessment of general demographic features(baseline)
- Assessment of earlier training in inhalation technique(baseline)
- Assessment of educational level(baseline)
- Assessment of quality of life related to COPD(baseline)
- Assesment of basic cognitive function(baseline)
- Assessment of patient's adherence(baseline)
- Assessment of asthma or COPD severity(baseline)
研究者
Marta Dąbrowska
Principal Investigator
Medical University of Warsaw