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

NCT ID: NCT05495256

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-03-22

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.

Conditions

Asthma; Copd

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MDI Training

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

Group Type: OTHER

Respimetrix

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gerresheimer

UNKNOWN

Sponsor Role: collaborator

Pulmonary Critical Care Associates of Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Alan Schwartz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pulmonary and Critical Care Associates Of Baltimor

Towson, Maryland, United States

Countries

United States

Other Identifiers

Respimetrix 2

Identifier Type: -

Identifier Source: org_study_id