Connect Lung Outcomes With Bronchodilator Use

NCT ID: NCT04417842

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-27
• Study Completion Date: 2022-04-25

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).

Conditions

Chronic Obstructive Pulmonary Disease; Asthma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Respimetrix flow-volume monitoring device

The Respimetrix flow-volume monitoring device is being tested to validate its ability to measure Inspiratory Capacity

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

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

Sponsors

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 Baltimore

Towson, Maryland, United States

Countries

United States

Other Identifiers

V1 21APR2020

Identifier Type: -

Identifier Source: org_study_id