Investigation of the Relationship Between the Respiratory Profile of Patients With Obstructive Pulmonary Disease and the Effectiveness of the Inhalation Therapies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- Correlation of respiratory function with inhalation drug deposition deposition
研究概览
简要总结
The primary aim of the OPTIPULM study is the evaluation of recorded pulmonary function curves and, based on them, the computer modelling of lung deposition for the individually used or potentially applicable inhalation drugs. The secondary aims include assessing the patients' inhalation device usage and providing recommendations for its optimization based on the recorded breathing curves and deposition calculations. The study also compares results across different flow rates and device resistances, aiming to identify the device with the highest modelled lung deposition for each patient.
Understanding and Improving Inhalation Therapy in Lung Disease The OPTIPULM study looks at how well inhaled medications reach the lungs of people living with asthma or COPD (chronic obstructive pulmonary disease). It aims to improve treatment by helping doctors choose the best inhaler for each patient based on how they breathe.
Every patient breathes differently, and not all inhalers work the same way. Sometimes the medicine doesn't reach deep enough into the lungs, which can make treatment less effective. This study helps doctors better understand which device works best for each individual.
What happens during the study? No new treatments or changes to medication are made.
Patients do a regular breathing test (like blowing into a tube). A computer program uses this breathing data to simulate how much medicine reaches the lungs with different inhalers.
Doctors can then make more personalized choices for inhalation therapy.
Who can take part? Adults with asthma or COPD who are able to use their inhaler correctly and complete a breathing test.
What is the benefit? Although the study does not change treatments directly, it helps improve future care by identifying the best-matching inhaler for each patient. This can lead to better symptom control and fewer exacerbations.
详细描述
Study Title:
Assessment of the Relationship Between Inhalation Therapy Effectiveness and Breathing Profiles in Patients with Obstructive Pulmonary Diseases (OPTIPULM)
The primary goal of this observational cross-sectional study is to analyze the relationship between patients' breathing characteristics and the effectiveness of their inhaled therapies. The study targets adult patients diagnosed with asthma or chronic obstructive pulmonary disease (COPD).
Background and Rationale:
Asthma and COPD are chronic obstructive airway diseases with increasing prevalence worldwide. Despite the availability of a wide range of inhaled medications and delivery devices, therapy is often suboptimal due to patient-specific factors such as improper inhalation technique or mismatch between inhaler resistance and the patient's inspiratory capacity.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Correlation of respiratory function with inhalation drug deposition deposition
时间窗: 01.01.2025 - 30.07.2025
The aims of the study are to evaluate the recorded respiratory function (spirometry), and on this basis, computer modelling of the lung deposition of inhalation drugs and selection of personalised therapy.
次要结局
未报告次要终点
