Assessing and Improving Misuse of Inhalers in COPD Outpatients

NCT07264140 | Not Yet Recruiting

• 1 other identifier: AIMO-COPD
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Chronic Obstructive Pulmonary Disease; Inhaler Technique; Inhaler Misuse; Peak Inspiratory Flow; Inhaler Education; Inhaler Optimization; Respiratory Physiotherapy; In-Check DIAL; Outpatient COPD Care

Outcome Measures

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.

  Month 12

Secondary Outcomes (11)

• Prevalence of critical inhaler technique errors at 12 months

  Month 12

• Prevalence of inadequate Peak Inspiratory Flow at 12 months

  Month 12

• Change in COPD Assessment Test (CAT) Score

  Baseline and Month 12

• Change in Clinical COPD Questionnaire (CCQ)

  Baseline and Month 12

• Change in Adherence to Inhaled Therapy (TAI Score)

  Baseline and Month 12

Other Outcomes (1)

• Change in the proportion of misused inhalers within the control group

  Baseline and Month 12

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Usual Outpatient COPD Care

NO INTERVENTION

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.

Interventions

Physiotherapist-Led Inhaler Optimization Program BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Ongoing participation in another interventional trial on inhaler technique

Sponsors & Collaborators

• Hôpital Fribourgeois: lead

Study Sites (1)

HFR Fribourg

Fribourg, Canton of Fribourg, 1700, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gaël Grandmaison, MD

CONTACT

+41 26 306 23 68; gael.grandmaison@h-fr.ch

Sandrine Foucras

CONTACT

+ 41 26 306 21 06; sandrine.froucras@h-fr.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned in a 1:1 ratio to either a structured, physiotherapist-led inhaler-optimization program or to usual outpatient COPD care. Both groups complete identical baseline and 12-month assessments, but only the intervention group receives three physiotherapist visits focused on inhaler technique review, peak inspiratory flow measurement, and individualized teach-to-goal education. Outcome assessors at Month 12 are blinded to group allocation.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• 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.

Locations

CH (1)