Assessing and Improving Misuse of Inhalers in COPD Outpatients (AIMO COPD)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Behavioral: Physiotherapist-Led Inhaler Optimization Program

Detailed Description

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Most patients rely on inhaled medications to control symptoms and reduce the risk of exacerbations. However, many patients do not use their inhalers correctly. Critical errors-such as incorrect preparation of the device, improper inhalation technique, or an inspiratory flow that is not appropriate for the device-are common and can lead to reduced drug delivery, poorer symptom control, and more frequent exacerbations. Previous studies conducted at the study site have shown that nearly 70% of hospitalized COPD patients used at least one inhaler incorrectly. In addition, peak inspiratory flow (PIF) varies between individuals, and many patients are unable to generate the flow required for certain dry powder inhalers. Despite this, regular assessment of inhaler technique and inspiratory flow is not systematically implemented in outpatient practice.

This randomized controlled trial evaluates whether a structured, physiotherapist-led inhaler-optimization program can reduce incorrect inhaler use among outpatients with COPD. The intervention includes three face-to-face visits over 12 months. During these sessions, physiotherapists trained in inhaler technique assessment use device-specific placebo inhalers and standardized checklists to identify critical errors. They also measure PIF with the In-Check DIAL® device, adjusted to the resistance of each patient's inhaler. The physiotherapist then provides individualized "teach-to-goal" education, with demonstration, correction, and repeated practice until mastery of the inhaler technique is achieved. When persistent errors or suboptimal PIF are identified, the physiotherapist informs the treating physician to consider adapting the type of inhaler.

Participants are randomly assigned (1:1) to the intervention group or the usual-care group. Usual care consists of regular management by the treating physician, which may include inhaler review at the physician's discretion, but without the structured physiotherapist-led sessions. Both groups undergo baseline and 12-month assessments that include inhaler technique evaluation using placebo devices, PIF measurement, respiratory questionnaires, and pulmonary function testing. Participants in both groups also receive telephone follow-up calls at months 2, 5, and 8 to assess symptoms, inhaler use, adherence, and confidence in inhaler use.

The primary endpoint is the proportion of misused inhalers at 12 months. An inhaler is considered misused if the patient demonstrates at least one critical technique error or if their measured PIF is outside the recommended range for their specific device. This composite outcome captures both aspects of inhaler adequacy: correct handling of the device and physiological ability to use it effectively. Because participants may use more than one inhaler device, the primary outcome is assessed at the inhaler level while accounting for clustering within participants. Secondary endpoints include changes in health status measured by validated respiratory questionnaires (CAT and CCQ), treatment adherence using the TAI questionnaire, satisfaction with inhalers, confidence in inhaler use, pulmonary function parameters, and the number of COPD exacerbations and hospitalizations over the 12-month follow-up.

The trial uses a pragmatic design to reflect real-world outpatient care. The inhaler-optimization program is intended to be simple, scalable, and easily integrated into routine COPD management. The educational approach is based on individualized instruction and repeated reinforcement, which patients in prior studies have reported as highly valuable. Outcome assessment at 12 months is performed by assessors who are not involved in delivering the intervention and are instructed to remain blinded to group allocation.

The study is minimal-risk and non-invasive. Potential risks include temporary fatigue or coughing during repeated inspiratory maneuvers and the time required for study visits and follow-up calls. The intervention does not involve investigational products or exposure to radiation. Data are collected according to Swiss data protection regulations using coded identifiers and secure REDCap databases.

By evaluating inhaler technique and inspiratory flow in a structured, standardized manner, this study aims to provide new evidence on how to improve inhaler use in COPD. Results may support more personalized device selection, enhance patient education practices, and reduce COPD exacerbations and associated healthcare burden. The findings may be applicable to a wide range of outpatient settings and could inform future guidelines on inhaler optimization in chronic respiratory diseases.

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaël Grandmaison, MD; Phone Number: +41 26 306 23 68; Email: gael.grandmaison@h-fr.ch
• Study Contact Backup: Name: Sandrine Foucras; Phone Number: + 41 26 306 21 06; Email: sandrine.froucras@h-fr.ch

Study Locations

• Switzerland
  • Canton of Fribourg
    • Fribourg, Canton of Fribourg, Switzerland, 1700
      • Hfr Fribourg
      • Contact: Gaël Grandmaison, MD; Phone Number: +41 26 306 23 68; Email: gael.grandmaison@h-fr.ch
      • Contact: Sandrine Foucras; Phone Number: + 41 26 306 21 06; Email: sandrine.froucras@h-fr.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Participants receive a structured, physiotherapist-led inhaler-optimization program in addition to their usual COPD care. The program includes three in-person visits at approximately Months 3, 6, and 9. During each visit, the physiotherapist assesses inhaler technique using device-specific placebo inhalers, measures peak inspiratory flow (PIF) with the In-Check DIAL® device, and provides individualized teach-to-goal inhaler education. If persistent critical errors or suboptimal PIF are identified, a recommendation is made to the treating physician to adapt the inhaler type. All participants undergo baseline and 12-month assessments identical to the control group.	Behavioral: Physiotherapist-Led Inhaler Optimization Program; This 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.
No Intervention: Usual Outpatient COPD Care; Participants receive standard outpatient COPD management from their treating physician. Usual care may include medication adjustments and inhaler review at the physician's discretion, but no structured physiotherapy sessions are added. Participants complete baseline and 12-month assessments identical to the intervention group, including inhaler technique evaluation, PIF measurement, respiratory questionnaires, and lung function testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First COPD Exacerbation	Time from randomization to the first COPD exacerbation requiring systemic corticosteroids, with or without antibiotics. Exacerbations are confirmed through medical records or treating physician.	Up to 12 months
Time to First COPD-Related Hospitalization	Time from randomization to the first unplanned hospital admission for a COPD exacerbation, confirmed through discharge documentation.	Up to 12 months
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.	Month 12
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.	Month 12
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.	Baseline and Month 12
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.	Baseline and Month 12
Change in Adherence to Inhaled Therapy (TAI Score)	Change in adherence measured with the Test of Adherence to Inhalers (TAI), a validated tool assessing intentional and unintentional non-adherence. Total score 10-50, higher scores indicate better adherence.	Baseline and Month 12
Change in Patient Satisfaction With Inhalers (FSI-10 Score)	Satisfaction with inhaler devices assessed using the 10-item Feeling of Satisfaction with Inhaler (FSI-10) questionnaire. Higher scores indicate greater satisfaction.	Baseline and Month 12
Change in Confidence in Inhaler Use	Change in confidence using a 7-point Likert-type scale ranging from 1 (no confidence) to 7 (complete confidence). Measured at baseline and Month 12 to assess improvement in inhaler self-efficacy.	Baseline and Month 12
Change in Pulmonary Function Parameters	Change in post-bronchodilator FEV₁ (liters and % predicted), FEV₁/FVC ratio, and FEF25-75%, measured according to ATS/ERS standards. Comparison of changes from baseline to Month 12 between groups.	Baseline and Month 12
Time to First Severe COPD Exacerbation	Time to first severe COPD exacerbation, defined as a COPD exacerbation requiring emergency department visit or hospitalization.	Up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Month 12

Collaborators and Investigators

• Sponsor: Hôpital Fribourgeois

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease; Respiratory Physiotherapy; Inhaler Technique; Peak Inspiratory Flow; Inhaler Misuse; Inhaler Education; Inhaler Optimization; In-Check DIAL; Outpatient COPD Care
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: AIMO-COPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the published results will be made available upon reasonable request after publication of the primary study results. The study protocol, informed consent form, statistical analysis plan, and analytic code will also be available upon reasonable request. Requests should be directed to the corresponding investigator and will be reviewed in accordance with institutional policies and applicable Swiss data protection regulations.
• IPD Sharing Time Frame: De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for at least 5 years thereafter upon reasonable request.
• IPD Sharing Access Criteria: Access to de-identified individual participant data and supporting documents (study protocol, statistical analysis plan, informed consent form, and analytic code) will be granted to qualified researchers whose proposed use of the data is methodologically sound and consistent with the aims of the study. Requests should be directed to the corresponding investigator and will be reviewed by the study team in accordance with institutional policies and applicable Swiss data protection regulations. Data will be shared in a de-identified format after approval of a data access request and, if required, after signature of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No