The Importance of Tailored Education And Device Handling for Asthmatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 6
- 主要终点
- Pulmonary deposition
研究概览
简要总结
Significant advancements have been made in asthma medication over the past decades. Highly effective treatments are available for patients; however, both adherence and proper device usage remain below the desired levels, based on our experience and literature data. Despite the availability of numerous excellent drug-device combinations, personalized treatment for patients is still not adequately addressed.
In the present study, the aim is to improve patient compliance and educate symptomatic, partially, or uncontrolled asthma patients on the correct use of a specific inhalation device (Nexthaler). Considering the characteristics of the medication, the patient's lung function data, inhalation technique, and drug retention time can help estimate the expected lung deposition of the medication. By refining the inhalation technique under the guidance of the treating physician, it is hypothesized that the expected therapeutic effects of the medication may improve.
详细描述
Eligible Patient Population:
Patients on GINA step 2-4 therapy who are partially or uncontrolled (ACT <25) and are receiving Foster Nexthaler® therapy as per prescribing guidelines, regardless of the study. Patients on GINA step 3 therapy receive a low-dose ICS-formoterol regimen (2x1 inhalations of Foster Nexthaler® 100/6 μg), while those on GINA step 4 receive a medium-dose ICS-formoterol regimen (2x2 inhalations of Foster Nexthaler® 100/6 μg). Whenever possible, Foster Nexthaler® 100/6 μg is used as a reliever medication following the MART principles. If the treating physician opts for salbutamol (Ventolin®, Buventol®) instead, the patient may still be included in the study, provided justification is given, considering the difficulty of training with multiple inhalation devices (pMDI and DPI with different characteristics).
Study Procedures:
Lung function tests will be performed on enrolled patients. The investigating physician will evaluate the recorded spirometry curves, which will be used for computer modeling to assess pulmonary drug deposition. The spirometry curves are also useful for evaluating the patient's condition and monitoring progress.
During the study visits (V1 - enrollment, V2 - 1 month, V3 - 3 months), the following data will be recorded: patient demographics, medical history, treatment details, risk factors, medication adherence (based on prescription refills and patient self-report), and quality of life assessment. Data collection, particularly questionnaire results, will follow the daily routine of the study center.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-confirmed clinical diagnosis of asthma according to GINA guidelines
- •Uncontrolled asthma according to the physician's clinical assessment despite the use of appropriate therapy of Step 2 or 3, according to GINA guidelines
- •Patients who are eligible for the use of Foster Nexthaler 100/6 mcg according to the SmPC
- •Inhaled asthma therapy was changed independent from the study to Foster Nexthaler 100/6 mcg DPI maximum 1 week prior to OR on the day of study inclusion
- •Spirometry was performed as part of routine clinical practice
- •Patient able to use their Foster Nexthaler device properly after education on inhaler technique
- •Patient provided written, informed consent to study participation
- •Patient ≥ 18 years of age
排除标准
- •Participation in any clinical trial, 30 days prior to inclusion
- •Patient is unable to execute a spirometry test
- •Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment.
- •Patients with other significant diseases of the respiratory system or other organ systems that may significantly contribute to asthma symptoms (such as severe heart failure, symptomatic anaemia, functional respiratory disorders, malignant diseases etc.) according to the physician's clinical assessment.
- •Continuous use of oral corticosteroids (>5 mg prednisolone/day or >4 mg methylprednisolone/day)
- •Use of continuous oxygen therapy
- •Use of biologics for asthma treatment
- •All exclusion criteria listed in Foster Nexthaler 100/6 SmPC
结局指标
主要结局
Pulmonary deposition
时间窗: 3 months
Difference of pulmonary deposition between patients performing different lengths of breath hold and it's changes after 3 months of treatment.
Asthma control questionnaire
时间窗: 3 months
Change in asthma control questionnaire (ACQ-6) scores after 3 months of treatment between patients performing different lengths of breath hold.
次要结局
- Lung function(3 months)
- Asthma control(3 months)
- Rescue medication(3 months)
- Adherence(3 months)
- Fractional exhaled nitric oxide(3 months)
- Health related quality of life(3 months)
- Adherence self report(3 months)