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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05495256
Enrollment
74
Registered
2022-08-10
Start date
2021-05-01
Completion date
2022-03-22
Last updated
2023-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Copd

Brief 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.

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.

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.

Sponsors

Gerresheimer
CollaboratorUNKNOWN
Pulmonary Critical Care Associates of Baltimore
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

patients are screened, consented, and all go through the inhaler training.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device2 weeksMeasure actuation timing, flow rate and volume after intervention

Secondary

MeasureTime frameDescription
Describing baseline pressurized metered-dose inhaler (pMDI) technique2 weeksMeasure actuation timing, flow rate and volume before intervention.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026