Connect Lung Outcomes With Bronchodilator Use

Completed

• Conditions: Asthma; Chronic Obstructive Pulmonary Disease

• Registration Number: NCT04417842
• Lead Sponsor: Pulmonary Critical Care Associates of Baltimore

Brief Summary

To determine the accuracy of the Respimetrix flow-volume monitoring device in measuring the patient's inspiratory capacity as compared to gold-standard measurements of inspiratory capacity on pulmonary function testing. Accuracy will be assessed before and after (A) pulmonary function testing and before and after (B) the administration of an inhaled bronchodilator medication.

Detailed Description

1. Specific Aim #1: Compare the performance of the flow-volume test device to standard pulmonary function measurements.

The investigators hypothesize that measurements of inspiratory capacity with the Respimetrix test device will:

A. Accurately measure the inspiratory capacity as assessed on standard pulmonary function tests, and will B. Correlate with other measures of pulmonary function including spirometry (vital capacity, forced expiratory volume in 1 second) and lung volumes (total lung capacity, functional residual capacity and residual volume).

2. Specific Aim #2: Examine the ability of the flow-volume test device to track changes in standard pulmonary function measurements after the administration of an inhaled bronchodilator.

The investigators hypothesize that the Respimetrix test device will:

A. Accurately measure changes in inspiratory capacity in response to a standard dose of a short acting inhaled beta-agonist (4 puffs albuterol), B. Correlate with immediate changes in pulmonary function parameters including spirometry (vital capacity, forced expiratory volume in 1 second) and lung volumes (total lung capacity, functional residual capacity and residual volume).

Study Timeline

• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-05
• Study Start: 2020-08-27
• Primary Completion: 2022-04-25
• Study Completion: 2022-04-25
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients 18 years of age or older who are being seen in the pulmonary clinic including Asthma and Chronic Obstructive Pulmonary Disease (COPD) patients.
• Patients must be willing and able to provide informed consent to participate in 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: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation	1 year	Validate the Respimetrix device as compared to pulmonary function test

Secondary Outcome Measures

Name	Time	Method
Validation	1 year	Validate Forced Vital Capacity, Forced expired volume in 1 sec, Total lung capacity and residual volume

Trial Locations

Locations (1)

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