AsthmaNCT05495256
Monitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.
A study testing Respimetrix in people with Asthma and Copd, run by Pulmonary Critical Care Associates of Baltimore at 1 site in United States.
Trial summary
To Determine whether use of the Respimetrix flow test device a) can determine "good" versus "poor" inhaler techniques, and b) the effects of the inhaler training on technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Respimetrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 22 Mar 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older
- Current diagnosis of asthma or Chronic obstructive pulmonary disease (COPD) patients
- Patients must be willing and able to provide informed consent to participate in the the study.
- Patients must be able to use a metered dose inhaler
Who cannot join
- Contraindication to inhaler use
- Tracheostomy
- Incapacitating disability that interferes with the use of the inhaler or execution of the protocol
- Unable to understand informed consent (e.g. non-English speakers)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pulmonary and Critical Care Associates Of Baltimor
Towson, Maryland, 21286
About this study
To Determine whether use of the Respimetrix flow test device a) can determine "good" versus "poor" inhaler techniques, and b) the effects of the inhaler training on technique.
Read the detailed description
Good metered dose inhaler (MDI) technique is described as sitting or standing upright with the head slightly tilted back, exhaling fully, and then inhaling slowly and deeply as you activate the MDI. Common mistakes include: not exhaling fully; not inhaling deeply enough; inhaling too quickly, and not activating the MDI at the proper time.
This study will use the Respimetrix device with placebo to assess a patient's inhaler technique, provide training to patients who demonstrate poor inhaler technique, and remotely track a subject's breathing ability over time.
- Being tested
- Respimetrix
- 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.
RespimetrixDevice
The Respimetrix device has a low resistance airflow sensor with an inhaler to measure patients inspiratory airflow and volume. This device will thereby provide quantifiable measures of lung function and bronchodilator delivery.
| Study group | Role | What they receive |
|---|---|---|
| MDI Training | Other | All participants are led through the MDI training with the Respimetrix Device. Protocol is within groups design. Receives: Device: Respimetrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device
Measure actuation timing, flow rate and volume after intervention
Measured: 2 weeks
Secondary outcomes (1)
Describing baseline pressurized metered-dose inhaler (pMDI) technique
Measure actuation timing, flow rate and volume before intervention.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 May 2021
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients are screened, consented, and all go through the inhaler training.
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmonary Critical Care Associates of Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Gerresheimer
- Responsible party
- Principal investigator, Alan Schwartz, Pulmonary Critical Care Associates of Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495256
- Sponsor's protocol ID
- Respimetrix 2
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
King SD, Milak RD, Schneider H, Sowho M, Katz EC, Schwartz AR. Flow Profiles Identify Sources of Poor Metered Dose Inhaler Technique: An Observational Study in Patients with Long-Term Pressurized Metered Dose Inhaler Use. CHEST Pulm. 2024 Nov 8;3(3):100116. doi: 10.1016/j.chpulm.2024.100116. eCollection 2025 Sep.
PubMed 42548343
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.
- ClinicalTrials.gov ID
- NCT05495256
- Acronym / sponsor ID
- Respimetrix 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Pulmonary Critical Care Associates of BaltimoreUniversity, hospital or other
- Collaborators
- Gerresheimer
- Study start
- 1 May 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 10 Aug 2022 (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.
To Determine whether use of the Respimetrix flow test device a) can determine "good" versus "poor" inhaler techniques, and b) the effects of the inhaler training on technique.
Detailed description
Good metered dose inhaler (MDI) technique is described as sitting or standing upright with the head slightly tilted back, exhaling fully, and then inhaling slowly and deeply as you activate the MDI. Common mistakes include: not exhaling fully; not inhaling deeply enough; inhaling too quickly, and not activating the MDI at the proper time.
This study will use the Respimetrix device with placebo to assess a patient's inhaler technique, provide training to patients who demonstrate poor inhaler technique, and remotely track a subject's breathing ability over time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients are screened, consented, and all go through the inhaler training.
| Arm | Type | Receives |
|---|---|---|
| MDI Training | Other | Device: RespimetrixAll participants are led through the MDI training with the Respimetrix Device. Protocol is within groups design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years of age or older
- Current diagnosis of asthma or Chronic obstructive pulmonary disease (COPD) patients
- Patients must be willing and able to provide informed consent to participate in the the study.
- Patients must be able to use a metered dose inhaler
Key exclusion criteria (4 listed)
- Contraindication to inhaler use
- Tracheostomy
- Incapacitating disability that interferes with the use of the inhaler or execution of the protocol
- Unable to understand informed consent (e.g. non-English speakers)
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 |
|---|---|---|
| RespimetrixThe Respimetrix device has a low resistance airflow sensor with an inhaler to measure patients inspiratory airflow and volume. This device will thereby provide quantifiable measures of lung function and bronchodilator delivery. | Device | MDI Training |
Primary outcome
Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device
Time frame: 2 weeks
Measure actuation timing, flow rate and volume after intervention
1 secondary outcome
Describing baseline pressurized metered-dose inhaler (pMDI) technique
Time frame: 2 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 28 Apr 2023.
- Derived from this study: PubMed 42548343King SD, Milak RD, Schneider H, Sowho M, Katz EC, Schwartz AR. Flow Profiles Identify Sources of Poor Metered Dose Inhaler Technique: An Observational Study in Patients with Long-Term Pressurized Metered Dose Inhaler Use. CHEST Pulm. 2024 Nov 8;3(3):100116. doi: 10.1016/j.chpulm.2024.100116. eCollection 2025 Sep.
- Individual participant dataSharing planned: No
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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 Respimetrix in people with Asthma and Copd, run by Pulmonary Critical Care Associates of Baltimore 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 4 inclusion and 4 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 28 Apr 2023. 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?
Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495256, which also lists 1 linked publication.
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 28 Apr 2023.