Connect Lung Outcomes With Bronchodilator Use (CLOUD)

April 26, 2023 updated by: Alan Schwartz, Pulmonary Critical Care Associates of Baltimore

CLOUD Study: Connect Lung Outcomes With Bronchodilator Use

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Towson, Maryland, United States, 21286
        • Pulmonary and Critical Care Associates of Baltimore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

- Patients 18 years of age or older who are being seen in the pulmonary clinic including Asthma and COPD patients.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation
Time Frame: 1 year
Validate the Respimetrix device as compared to pulmonary function test
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation
Time Frame: 1 year
Validate Forced Vital Capacity, Forced expired volume in 1 sec, Total lung capacity and residual volume
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pulmonary Critical Care Associates of Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2020

Primary Completion (Actual)

April 25, 2022

Study Completion (Actual)

April 25, 2022

Study Registration Dates

First Submitted

June 2, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (Actual)

June 5, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1 21APR2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Validating a device for Respimetrix, no immediate plan to share data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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