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

Not Applicable

Completed

• Conditions: Asthma; Copd
• Interventions: Device: Respimetrix

• Registration Number: NCT05495256
• Lead Sponsor: Pulmonary Critical Care Associates of Baltimore

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.

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2022-03-22
• Study Completion: 2022-03-22
• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device	2 weeks	Measure actuation timing, flow rate and volume after intervention

Secondary Outcome Measures

Name	Time	Method
Describing baseline pressurized metered-dose inhaler (pMDI) technique	2 weeks	Measure actuation timing, flow rate and volume before intervention.

Trial Locations

Locations (1)

Pulmonary and Critical Care Associates Of Baltimor; 🇺🇸 Towson, Maryland, United States