Assessing and Improving Misuse of Inhalers in COPD Outpatients

A vizsgálat adatai

Ki végzi

Hôpital Fribourgeois

Azonosító

NCT07264140

A regiszteradat frissítve

2026. május 14.

Eredeti leírás

Chronic obstructive pulmonary disease (COPD) is a common long-term lung disease that causes breathlessness, cough, and frequent flare-ups. Most patients with COPD use inhaled medications every day. However, many people do not use their inhalers correctly, or they cannot generate the right inspiratory flow for their device. When inhalers are used incorrectly, the medication does not reach the lungs properly, symptoms worsen, and the risk of exacerbations increases.A teljes eredeti leírásKevesebb

Assessing and Improving Misuse of Inhalers in Outpatients With COPD - The AIMO COPD Study

Chronic obstructive pulmonary disease (COPD) is a common long-term lung disease that causes breathlessness, cough, and frequent flare-ups. Most patients with COPD use inhaled medications every day. However, many people do not use their inhalers correctly, or they cannot generate the right inspiratory flow for their device. When inhalers are used incorrectly, the medication does not reach the lungs properly, symptoms worsen, and the risk of exacerbations increases.

This pragmatic randomized controlled trial evaluates whether a structured physiotherapist-led inhaler optimization program improves inhaler use in routine outpatient COPD care. The program is delivered by trained physiotherapists over 12 months and includes three in-person sessions. During these sessions, the physiotherapist evaluates the patient's inhaler technique using placebo devices, measures the patient's peak inspiratory flow with the In-Check DIAL® device, and provides individualized "teach-to-goal" education to help patients use their inhalers correctly. If the patient continues to make critical errors or cannot generate the appropriate inspiratory flow for their inhaler, the physiotherapist may recommend adapting the type of inhaler to better match the patient's abilities.

Participants will be randomly assigned to one of two groups. The intervention group will receive the structured program in addition to their usual COPD care. The control group will continue with usual outpatient care without the physiotherapist-led sessions. All participants will complete baseline and 12-month assessments, which include inhaler technique evaluation, inspiratory flow measurement, respiratory questionnaires, and lung function tests. Telephone follow-up calls will be performed at months 2, 5, and 8 to monitor symptoms, inhaler use, and adherence.

The main outcome of the study is the proportion of inhalers used incorrectly at 12 months. Incorrect use is defined as at least one critical inhaler technique error or an inspiratory flow that is too low or too high for the patient's device. Secondary outcomes include changes in respiratory symptoms, health status, adherence to inhaled treatment, patient satisfaction with inhalers, confidence in inhaler use, and the number of COPD exacerbations or hospitalizations during the study.

This research may help improve everyday inhaler use in people with COPD and support more personalized inhaler selection in routine clinical care. Although participants may not benefit directly, the study poses minimal risks and may contribute to future improvements in COPD management.

Bevonási feltételek: Age ≥18 years; COPD confirmed by spirometry (FEV1/FVC <0.7); Current use of at least one maintenance inhaler; Follow-up at the outpatient pneumology clinic of HFR Fribourg; Ability to provide written informed consent.

Kizáró feltételek: Inability to provide informed consent (e.g. severe cognitive impairment, advanced psychiatric disorder, unresolved language barrier); Predominant other chronic lung disease (e.g. asthma, fibrosis); Any condition preventing completion of study procedures; Life expectancy <12 months; Ongoing participation in another interventional trial on inhaler technique.

ClinicalTrials.gov NCT07264140