Inhaler Trainer Efficacy Study

NCT06461403 | Recruiting DMC

• 2 other identifiers: IRB21-14185R44AG071430
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized, controlled, clinical trial. The investigators aim to determine the feasibility of and efficacy of the Inhaler Trainer Device for ongoing inhaler skill training. The research team will enroll 140 patients from the inpatient or outpatient setting from the University of Chicago Medicine over the course of up to 12 months. Participants will complete assessments, a lung function test via spirometry, and inhaler education via either the Inhaler Trainer Device learning program or Brief Intervention. All participants will return at 6 weeks (window of +/- one week) post-initial inhaler education for an in-person evaluation of their inhaler skills, lung function, and acute care utilization. Finally, a post-study semi-structured interview will be conducted to gather feedback on the device after the 6-week visit has been completed.

Conditions

Asthma; Copd; Acute Exacerbation of COPD

Outcome Measures

Primary Outcomes (1)

• Inhaler technique assessment

  Participants' overall inhaler technique will be scored via observation by a trained research educator. This assessment will follow a validated checklist and scoring system based the inhaler the patient is using. For example, if the patient is using a Spiriva handihaler, each of the following steps will be marked as either complete or incomplete: removes cap of inhaler and spacer, shakes inhaler up and down, attaches inhaler to spacer, breathes out fully, breathes out away from spacer/MDI, closes lips around spacer mouthpiece, presses down on canister one time, breathes in slowly, holds breath for at least five seconds, removes spacer from mouth before breathing normally, breathes normally for at least 30-60 seconds, repeats steps 2-11 for second puff. There will be a designated spot for any qualitative findings identified by the educator. Scores will be compared to baseline and post-training results at 6 weeks post-inhaler technique training.

  6 weeks

Secondary Outcomes (13)

• Estimated inhaled dosage

  6 weeks

• Usability

  6 weeks

• Spirometer pulmonary function measures

  6 weeks

• Spirometer pulmonary function measure: FVC

  6 weeks

• Spirometer pulmonary function measure: PEF

  6 weeks

Study Arms (2)

Inhaler Trainer Device

EXPERIMENTAL

The Inhaler Trainer Device will monitor patients' inspiratory waveform to confirm technique compliance based on objective metrics and provide feedback on how to better perform technique. This intervention utilizes an instrumented training inhaler capable of accurately measuring the real-time inspiratory airflow achieved by the user when they perform their inhale maneuver. If a user's inspiratory flow fails to produce an inspiratory waveform with sufficient airflow parameters, the inhaler device may not optimally aerosolize the medication, and the delivered dosage to the lung will be negatively affected. The device measures the most important flow parameters in the users' real-time inspiration performance and translates them into an estimation of the dose delivered to the lung, based on detailed characterization of the user's inhaler product.

Device: Inhaler Trainer System; Other: Initial Inhaler Use Assessment; Other: Inhaler Use Instruction

Brief Interventions (BI)

ACTIVE COMPARATOR

During inpatient admission, participants randomized to the BI condition will receive the following: First, they will undergo an initial assessment of their respiratory inhaler technique using device-specific checklists. Participants will then be given step-by-step verbal instructions and a copy of written instructions by the trained educator describing appropriate inhaler technique for their respiratory inhalers. The educator will not demonstrate the appropriate use of each inhaler to the patient, though the educator will be free to answer questions about appropriate use if posed by the study subject.

Other: Initial Inhaler Use Assessment; Other: Inhaler Use Instruction

Interventions

Inhaler Trainer System DEVICE

The system consists of an instrumented training inhaler capable of accurately measuring the real-time inspiratory airflow achieved by the user when they perform their inhale maneuver. The inhaler trainer system consists of a detachable/disposable mouthpiece and a reusable electronics module. The electronics module measures flow/pressure achieved by the patient and wirelessly transmits this data to a PC. The PC software analyzes the real-time inhalation flow data to enable the monitoring of the following quantities: Flow Rate, Duration, and Maximum Pressure Slope. These quantities will be used in the computation of the assessment metric, providing the user with real-time feedback about their inhalation technique. In addition, the software includes features to support the human study and provides fully functional inhaler education features for the expert test evaluators.

Inhaler Trainer Device

Initial Inhaler Use Assessment OTHER

Patients will undergo an initial assessment of their respiratory inhaler technique for their respiratory inhaler devices using device-specific checklists

Brief Interventions (BI); Inhaler Trainer Device

Inhaler Use Instruction OTHER

Participants will then be given step-by-step verbal instructions and a copy of written instructions by the trained educator describing appropriate inhaler technique for their respiratory inhalers.

Brief Interventions (BI); Inhaler Trainer Device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85
• Physician diagnosis of COPD or asthma
• Has been prescribed or is being prescribed one of the inhalers listed below (DPI inhaler product, Active pharmaceutical ingredient):
• Serevent®Diskus®(GSK), Salmeterol
• Incruse Ellipta (GSK), Umeclidinium
• Spiriva Handihaler (BIP),Tiotropium
• Tudorza Pressair (AstraZeneca), Aclidinium
• Inexperienced with inhaler trainer device (defined by never having had inhaler training using an auxiliary tool besides an actual inhaler and spacer)

You may not qualify if:

• Physician declines to provide assent
• Patient unable to provide consent (e.g., history of cognitive impairment, unable to understand English) or declines to provide consent

Sponsors & Collaborators

• Koronis Biomedical Technologies: lead
• University of Chicago: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Leah Traeger

CONTACT

847-508-3011; ltraeger@bsd.uchicago.edu

Valerie Press

CONTACT

734-717-1131; vpress@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: June 17, 2024
• Study Start: October 9, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-08

Data Sharing

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

Locations

US (1)