Connect Lung Outcomes With Bronchodilator Use

NCT04417842 | Completed

• 1 other identifier: V1 21APR2020
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Asthma

Outcome Measures

Primary Outcomes (1)

• Validation

  Validate the Respimetrix device as compared to pulmonary function test

  1 year

Secondary Outcomes (1)

• Validation

  1 year

Interventions

Respimetrix flow-volume monitoring device DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pulmonary Critical Care Associates of Baltimore: lead

Study Sites (1)

Pulmonary and Critical Care Associates Of Baltimore

Towson, Maryland, 21286, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 5, 2020
• Study Start: August 27, 2020
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)