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Connect Lung Outcomes With Bronchodilator Use

CLOUD Study: Connect Lung Outcomes With Bronchodilator Use

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04417842
Acronym
CLOUD
Enrollment
30
Registered
2020-06-05
Start date
2020-08-27
Completion date
2022-04-25
Last updated
2023-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Chronic Obstructive Pulmonary Disease

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).

Interventions

DIAGNOSTIC_TESTRespimetrix flow-volume monitoring device

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

Sponsors

Pulmonary Critical Care Associates of Baltimore
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frameDescription
Validation1 yearValidate the Respimetrix device as compared to pulmonary function test

Secondary

MeasureTime frameDescription
Validation1 yearValidate Forced Vital Capacity, Forced expired volume in 1 sec, Total lung capacity and residual volume

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026