AsthmaNCT06461403
Inhaler Trainer Efficacy Study
A study testing Inhaler Trainer System, Initial Inhaler Use Assessment and Inhaler Use Instruction in people with Asthma and Copd, run by Koronis Biomedical Technologies at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Copd, Acute Exacerbation of COPD
- What is being tested?
- Inhaler Trainer System, Initial Inhaler Use Assessment and Inhaler Use Instruction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2025to 28 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inhaler Trainer Efficacy Study: Interactive Training Tool Providing Technique Feedback for COPD/Asthma Medication Delivery
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.
Read the detailed description
The research team will enroll 140 patients from the inpatient or outpatient setting from the University of Chicago Medicine inpatient services, COPD/APN clinic, general medicine clinic, and/or Pulmonary clinic until all participants have been enrolled (approximately over the course of 12 months).
Patients will be randomized into one of two treatment conditions: one including use of the inhaler training device and one with our standard brief intervention.
After obtaining informed consent, participants will complete assessments, including a lung function test via spirometry, and inhaler education via either the Inhaler Trainer Device learning program or standard education techniques. Participants randomized to the inhaler training device arm will be trained on how to use their inhaler and the inhaler trainer device. The Inhaler Trainer Device will monitor the patient's inspiratory waveform to confirm technique compliance based on objective metrics and provide feedback on how to better perform technique.
Participants will continue to use their inhaled medications with the inhaler trainer device for 6 weeks post-baseline. They will return at 6 weeks post-initial instruction 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. This interview will occur either during the 6-week follow-up visit or at a later time via phone call or zoom call. In the interview, a standard elicitation framework guided by the Integrative Model (IM) of Behavioral Prediction and Change will be used to generate feedback on training experience. The research team will also prompt participants to give feedback on the design, content, and functionality of the inhaler and training system. Additional prompts and questions will be used to ensure that information is provided that speaks to participants' perceptions of the positive and negative consequences related to using the trainer.
The statistical team at the University of Chicago will conduct analyses including descriptive summaries using means, medians, proportions, scatterplots, and histograms to describe the data. McNemar's chi-squared tests will be used to compare 30-day follow-up and inhaler misuse (≤10/12 steps correct) post-education vs. baseline. To model over time, we will use generalized linear mixed method (GLMM) or generalized estimating equations (GEE). A two-tailed p-value less than 0.05 will define statistical significance. The sample size was powered on the primary outcome in Aim 1 for difference in correct MDI use (>75% steps correct) between baseline and at 6 weeks.
- Conditions
- Asthma, Copd, Acute Exacerbation of COPD
- Being tested
- Inhaler Trainer System, Initial Inhaler Use Assessment, Inhaler Use Instruction
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaler Trainer SystemDevice
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.
Initial Inhaler Use AssessmentOther
Patients will undergo an initial assessment of their respiratory inhaler technique for their respiratory inhaler devices using device-specific checklists
Inhaler Use InstructionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Initial Inhaler Use Assessment; Other: Inhaler Use Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (13)
Estimated inhaled dosage
Estimated inhaled dosage is estimated by the prototype training device and is used to inform the training session. Dosage will be compared to the baseline and training session. Dosage will be compared to the baseline and training session results at 6 weeks post inhaler technique training.
Measured: 6 weeks
Usability
To assess the overall usability and acceptability of the system, a short Likert-type usability survey will be developed based on the system usability scale and tailored to their inhaler type. For example, participants may be asked on a scale from 1-5, to what degree they agree to statements similar to "I thought the training system was easy to use", with 1 being strongly disagree, and 5 being strongly agree. Participants will complete the assessment, which will be administered by a trained interviewer.
Measured: 6 weeks
Spirometer pulmonary function measures
Forced Expiratory Volume in One Minute (FEV1). Scores will be compared to baseline at 6 weeks post inhaler technique training.
Measured: 6 weeks
Spirometer pulmonary function measure: FVC
Forced Vital Capacity (FVC). Scores will be compared to baseline at 6 weeks post inhaler technique training.
Measured: 6 weeks
Spirometer pulmonary function measure: PEF
Peak Expiratory Flow (PEF). Scores will be compared to baseline at 6 weeks post inhaler technique training.
Measured: 6 weeks
Inhalation Parameters - flow slope
Flow slope will be measured by the prototype trainer device and compared to the baseline and training session at 6 weeks post inhaler technique training.
Measured: 6 weeks
Inhalation Parameters - peak flow
Peak flow will be measured by the prototype trainer device and compared to the baseline and training session at 6 weeks post inhaler technique training.
Measured: 6 weeks
Inhalation Parameters - total volume
Total volume will be measured by the prototype trainer device and compared to the baseline and training session results at 6 weeks post inhaler technique training.
Measured: 6 weeks
Symptom Control: mMRC
Symptoms will be assessed with the mMRC(Modified Medical Research Counsel dyspnea scale assessment), a validated tool that stratifies severity of dyspnea in respiratory diseases, particularly COPD. It is often used to establish baseline functional impairment due to dyspnea attributable to respiratory disease. The minimum value from this tool is 0, which indicates that the patient "only gets breathless with strenuous exercise". The maximum value of the tool is 4, which indicates that the patient "is too breathless to leave the house or is breathless when dressing". Results will be compared to the baseline and training session results at 6 weeks post inhaler technique training.
Measured: 6 weeks
Symptom Control: Modified Borg Dyspnea Scale
Symptoms will be assessed with the Modified Borg Dyspnea Scale. The minimum value of this tool is 0, which indicates that the patient experiences no shortness of breath. The maximum value of this tool is 10, which indicates that the patient is experiencing very severe shortness of breath. Results will be compared to the baseline and training session results at 6 weeks post inhaler technique training.
Measured: 6 weeks
Symptom control: Asthma
Asthma symptoms will be measured by the following assessments: ASSI (Asthma Symptom Severity Index). Patients will give a number in response to the question: "How is your asthma/COPD right now?" from 0 - 10, with 0 indicating no symptoms, and 10 indicating maximal symptoms. Results will be compared to the baseline and training session results at 6 weeks post inhaler technique training.
Measured: 6 weeks
Disease control: COPD
COPD disease control will be measured with the CAT (COPD Assessment Test), which is a questionnaire for people with COPD that is designed to measure the impact of COPD on a person's life. The questionnaire is composed of 8 statements/questions with which the patient responds on a 0-5 scale. Total scores for the questionnaire can range from 0 - 40, with 0 indicating well controlled COPD and 40 indicating extremely poorly controlled COPD. Results will be compared to the baseline and training session results at 6 weeks post inhaler technique training.
Measured: 6 weeks
Disease control: Asthma
Asthma control will be measured with the asthma control questionnaire. This questionnaire measures the adequacy of asthma control and change in asthma control that occurs either spontaneously or as a result of treatment. It is a 20 item questionnaire surveying effects of breathing problems on patients' everyday life. There are two sections to the questionnaire. The first 13 questions have answers ranging from 1-3, (1 = YES, 2 = NO, and 3 = N/A). The last 7 questions have answers ranging from 1-4 (1 = YES, 2 = NO, 3 = UNABLE, 4 = N/A). Results will be compared to the baseline and training session results at 6 weeks post inhaler technique training.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start9 Oct 2025
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 randomization
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koronis Biomedical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Chicago, National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461403
- Sponsor's protocol ID
- IRB21-1418
- Other IDs
- 5R44AG071430
- Status last verified
- Jun 2026
- First submitted
- 12 Apr 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Koronis Biomedical Technology researchers and our collaborative research partners at the University of Chicago are active contributors to a variety of peer-reviewed publications, academic conference venues, and industrial consortiums. A wide variety of research conclusions stemming from the proposed project will be submitted for public disclosure through these various venues. We aim to spur improvements to COPD/asthma and COPD/asthma disease management options worldwide. It is our express intention to participate in the research endeavor of the larger research community and we have several strategies to explicitly share our data, insight and analysis tools while maintaining subject confidentiality. We intend to broadly disseminate our insights through prompt and complete publication in peer-reviewed journals. Additionally, Koronis Biomedical Technologies will adopt the NIH Policy for dissemination of NIH-Funded Clinical trial information, published in full as NOT-OD-16-149.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaler Trainer Efficacy Study: Interactive Training Tool Providing Technique Feedback for COPD/Asthma Medication Delivery
- ClinicalTrials.gov ID
- NCT06461403
- Acronym / sponsor ID
- IRB21-1418
- Conditions
- Asthma, Copd, Acute Exacerbation of COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Koronis Biomedical TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- University of Chicago, National Institute on Aging (NIA)
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research team will enroll 140 patients from the inpatient or outpatient setting from the University of Chicago Medicine inpatient services, COPD/APN clinic, general medicine clinic, and/or Pulmonary clinic until all participants have been enrolled (approximately over the course of 12 months).
Patients will be randomized into one of two treatment conditions: one including use of the inhaler training device and one with our standard brief intervention.
After obtaining informed consent, participants will complete assessments, including a lung function test via spirometry, and inhaler education via either the Inhaler Trainer Device learning program or standard education techniques. Participants randomized to the inhaler training device arm will be trained on how to use their inhaler and the inhaler trainer device. The Inhaler Trainer Device will monitor the patient's inspiratory waveform to confirm technique compliance based on objective metrics and provide feedback on how to better perform technique.
Participants will continue to use their inhaled medications with the inhaler trainer device for 6 weeks post-baseline. They will return at 6 weeks post-initial instruction 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. This interview will occur either during the 6-week follow-up visit or at a later time via phone call or zoom call. In the interview, a standard elicitation framework guided by the Integrative Model (IM) of Behavioral Prediction and Change will be used to generate feedback on training experience. The research team will also prompt participants to give feedback on the design, content, and functionality of the inhaler and training system. Additional prompts and questions will be used to ensure that information is provided that speaks to participants' perceptions of the positive and negative consequences related to using the trainer.
The statistical team at the University of Chicago will conduct analyses including descriptive summaries using means, medians, proportions, scatterplots, and histograms to describe the data. McNemar's chi-squared tests will be used to compare 30-day follow-up and inhaler misuse (≤10/12 steps correct) post-education vs. baseline. To model over time, we will use generalized linear mixed method (GLMM) or generalized estimating equations (GEE). A two-tailed p-value less than 0.05 will define statistical significance. The sample size was powered on the primary outcome in Aim 1 for difference in correct MDI use (>75% steps correct) between baseline and at 6 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Inhaler Trainer Device | Experimental | Device: Inhaler Trainer System, Other: Initial Inhaler Use Assessment, Other: Inhaler Use InstructionThe 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. |
| Brief Interventions (BI) | Active comparator | Other: Initial Inhaler Use Assessment, Other: Inhaler Use InstructionDuring 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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):
- Inexperienced with inhaler trainer device (defined by never having had inhaler training using an auxiliary tool besides an actual inhaler and spacer)
Key exclusion criteria (3 listed)
- 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
- Does not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaler Trainer SystemThe 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. | Device | Inhaler Trainer Device |
| Initial Inhaler Use AssessmentPatients will undergo an initial assessment of their respiratory inhaler technique for their respiratory inhaler devices using device-specific checklists | Other | Brief Interventions (BI), Inhaler Trainer Device |
| Inhaler Use InstructionParticipants 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. | Other | Brief Interventions (BI), Inhaler Trainer Device |
Primary outcome
Inhaler technique assessment
Time frame: 6 weeks
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.
13 secondary outcomes
Estimated inhaled dosage
Time frame: 6 weeks
Usability
Time frame: 6 weeks
Spirometer pulmonary function measures
Time frame: 6 weeks
Spirometer pulmonary function measure: FVC
Time frame: 6 weeks
Spirometer pulmonary function measure: PEF
Time frame: 6 weeks
Inhalation Parameters - flow slope
Time frame: 6 weeks
Inhalation Parameters - peak flow
Time frame: 6 weeks
Inhalation Parameters - total volume
Time frame: 6 weeks
Symptom Control: mMRC
Time frame: 6 weeks
Symptom Control: Modified Borg Dyspnea Scale
Time frame: 6 weeks
Symptom control: Asthma
Time frame: 6 weeks
Disease control: COPD
Time frame: 6 weeks
Disease control: Asthma
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Yes. Koronis Biomedical Technology researchers and our collaborative research partners at the University of Chicago are active contributors to a variety of peer-reviewed publications, academic conference venues, and industrial consortiums. A wide variety of research conclusions stemming from the proposed project will be submitted for public disclosure through these various venues. We aim to spur improvements to COPD/asthma and COPD/asthma disease management options worldwide. It is our express intention to participate in the research endeavor of the larger research community and we have several strategies to explicitly share our data, insight and analysis tools while maintaining subject confidentiality. We intend to broadly disseminate our insights through prompt and complete publication in peer-reviewed journals. Additionally, Koronis Biomedical Technologies will adopt the NIH Policy for dissemination of NIH-Funded Clinical trial information, published in full as NOT-OD-16-149.
Related trials for Asthma
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaler Trainer System, Initial Inhaler Use Assessment and Inhaler Use Instruction in people with Asthma and Copd, run by Koronis Biomedical Technologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhaler technique assessment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.