Assessing and Improving Misuse of Inhalers in COPD Outpatients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHôpital Fribourgeois
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to provide informed consent (e.g. severe cognitive impairment, advanced psychiatric disorder, unresolved language barrier)
Life expectancy <12 months
Predominant other chronic lung disease (e.g. asthma, fibrosis)
Any condition preventing completion of study procedures
Trial design
Design model
Parallel
Treatments tested in this trial
Physiotherapist-Led Inhaler Optimization Program
BehavioralThis intervention consists of a structured, physiotherapist-led inhaler-optimization program delivered over 12 months in addition to usual outpatient COPD care. Participants attend three face-to-face sessions at Months 3, 6, and 9. During each session, a trained physiotherapist evaluates inhaler technique using device-specific placebo inhalers and validated checklists, measures peak inspiratory flow (PIF) with the In-Check DIAL® device adjusted to the resistance of each inhaler, and provides individualized teach-to-goal education with iterative demonstration and feedback until correct technique is achieved. If the participant continues to demonstrate critical errors or cannot generate an adequate PIF for their prescribed device, the physiotherapist notifies the treating physician and recommends adapting the inhaler type. The intervention does not include medication changes or pharmacologic treatment.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Usual Outpatient COPD CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Proportion of Misused Inhalers at 12 Months
An inhaler is classified as misused if the participant demonstrates at least one critical inhaler technique error or if the measured peak inspiratory flow (PIF) is outside the recommended range for the specific device. Critical errors are assessed using device-specific standardized checklists with placebo inhalers. PIF is measured using the In-Check DIAL® device set to the resistance of each inhaler. The first PIF measurement, reflecting the participant's usual inhalation technique, is used to classify misuse. Device-specific thresholds define insufficient PIF for dry powder inhalers and excessive PIF for pMDIs or soft-mist inhalers. The analysis will be conducted at the inhaler level using statistical methods accounting for clustering of inhalers within participants.
Time frame
Month 12Secondary outcomes
1
Prevalence of critical inhaler technique errors at 12 months
Critical inhalation technique error, defined as an error likely to result in insufficient delivery of medication to the lungs. Errors will be assessed using device-specific standardized checklists, based on validated reference frameworks identifying critical steps for each inhaler type. The analysis will be conducted at the inhaler level using statistical methods accounting for clustering of inhalers within participants.
Time frame
Month 122
Prevalence of inadequate Peak Inspiratory Flow at 12 months
Suboptimal Peak Inspiratory Flow is measured using the In-Check DIAL® set to the resistance corresponding to the patient's inhaler. For dry powder inhalers, Peak Inspiratory Flow values below the device-specific recommended threshold will be considered insufficient. For pressurized metered-dose inhalers or soft mist inhalers, PIF values above the recommended range will be considered excessive. The first measurement reflects the patient's actual inhalation performance in routine conditions and is therefore used to classify misuse. Threshold values will be based on published device-specific recommendations. The analysis will be conducted at the inhaler level using statistical methods accounting for clustering of inhalers within participants.
Time frame
Month 123
Change in COPD Assessment Test (CAT) Score
Change in health status measured with the COPD Assessment Test (CAT), a validated 8-item questionnaire (score range 0-40, higher scores indicate worse symptoms). The change from baseline to Month 12 will be compared between groups.
Time frame
Baseline and Month 124
Change in Clinical COPD Questionnaire (CCQ)
Change in health status measured with the Clinical COPD Questionnaire (CCQ), a validated 10-item questionnaire. Each item is scored on a seven-point Likert scale ranging from 0 (no impairment) to 6 (maximal impairment). The overall score corresponds to the mean of all item scores and therefore ranges from 0 to 6, with higher values indicating worse disease control and greater functional limitation. The change from baseline to Month 12 will be compared between groups.
Time frame
Baseline and Month 12Other outcomes
1
Change in the proportion of misused inhalers within the control group
Within the control group, the change in the proportion of misused inhalers between baseline and Month 12 will be analyzed to assess the effect of a standardized pneumology consultation alone.
Time frame
Baseline and Month 12Sponsors and contacts
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Source ClinicalTrials.gov
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