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

NCT05495256 | Completed FDA Device

• 1 other identifier: Respimetrix 2
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Copd

Outcome Measures

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

  2 weeks

Secondary Outcomes (1)

• Describing baseline pressurized metered-dose inhaler (pMDI) technique

  2 weeks

Study Arms (1)

MDI Training

OTHER

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

Device: Respimetrix

Interventions

Respimetrix 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.

MDI Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pulmonary Critical Care Associates of Baltimore: lead
• Gerresheimer: collaborator

Study Sites (1)

Pulmonary and Critical Care Associates Of Baltimor

Towson, Maryland, 21286, United States

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: August 10, 2022
• Study Start: May 1, 2021
• Primary Completion: March 22, 2022
• Study Completion: March 22, 2022
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)