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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05495256
• Other study ID #: Respimetrix 2
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: March 22, 2022

Study information

• Verified date: April 2023
• Source: Pulmonary Critical Care Associates of Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 22, 2022
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Asthma
• Copd
• Lung Diseases
• Lung Diseases, Obstructive

Intervention

Device:
• Respimetrix
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.

Locations

Country	Name	City	State
United States	Pulmonary and Critical Care Associates Of Baltimor	Towson	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Pulmonary Critical Care Associates of Baltimore	Gerresheimer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device	Measure actuation timing, flow rate and volume after intervention	2 weeks
Secondary	Describing baseline pressurized metered-dose inhaler (pMDI) technique	Measure actuation timing, flow rate and volume before intervention.	2 weeks