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OpenTrials
Completed

NCT Number: NCT04417842

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.

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Key information

About this study

  • 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).

  • 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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Respimetrix flow-volume monitoring device

Diagnostic Test

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

Primary outcomes

  1. Validation

    Time frame: 1 year

    Validate the Respimetrix device as compared to pulmonary function test

Secondary outcomes

  1. Validation

    Time frame: 1 year

    Validate Forced Vital Capacity, Forced expired volume in 1 sec, Total lung capacity and residual volume

Sponsors and collaborators

Lead sponsor

Pulmonary Critical Care Associates of Baltimore

Other

Registry information

Official study title

CLOUD Study: Connect Lung Outcomes With Bronchodilator Use

Acronym: CLOUD

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 5, 2020
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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