Connect Lung Outcomes With Bronchodilator Use

Asthma Clinical Trial

— CLOUD  

Official title:

CLOUD Study: Connect Lung Outcomes With Bronchodilator Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417842
• Other study ID #: V1 21APR2020
• Status: Completed
• Start date: August 27, 2020
• Est. completion date: April 25, 2022

Study information

• Verified date: April 2023
• Source: Pulmonary Critical Care Associates of Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 25, 2022
• Est. primary completion date: April 25, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	Pulmonary and Critical Care Associates Of Baltimore	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Pulmonary Critical Care Associates of Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation	Validate the Respimetrix device as compared to pulmonary function test	1 year
Secondary	Validation	Validate Forced Vital Capacity, Forced expired volume in 1 sec, Total lung capacity and residual volume	1 year