CClinicalTrials.gg
CompletedNCT05495256Updated Apr 28, 2023

Monitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.

An interventional study of Respimetrix in Asthma and Copd, sponsored by Pulmonary Critical Care Associates of Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-28.

Sponsored by Pulmonary Critical Care Associates of Baltimore · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was Mar 2022, 4 years 6 months ago, and no results have been posted to the registry.
  • Registered 11 months after the study started (first participant enrolled May 2021, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 74 is close to the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Pulmonary Critical Care Associates of Baltimore is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

  • Other
    MDI Training

    All participants are led through the MDI training with the Respimetrix Device. Protocol is within groups design.

    Device: Respimetrix

Interventions

  • DeviceRespimetrix

    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.

06

What researchers measure

Primary outcomes

  1. Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device

    Measure actuation timing, flow rate and volume after intervention

    Time frame: 2 weeks

Secondary outcomes

  1. Describing baseline pressurized metered-dose inhaler (pMDI) technique

    Measure actuation timing, flow rate and volume before intervention.

    Time frame: 2 weeks

07

Study locations

1 site
  • Pulmonary and Critical Care Associates Of Baltimor
    Towson, Maryland 21286, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05495256
Lead sponsor
Pulmonary Critical Care Associates of Baltimore
Collaborators
Gerresheimer
Responsible party
Alan Schwartz (Principal Investigator, Pulmonary Critical Care Associates of Baltimore) — Principal investigator
First posted
Aug 10, 2022
Start date
May 1, 2021
Primary completion
Mar 22, 2022
Completion
Mar 22, 2022
Last update
Apr 28, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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