Connect Lung Outcomes With Bronchodilator Use | NCT04417842

Studies
Connect Lung Outcomes With Bronchodilator Use

NCT04417842

Sponsor

Pulmonary Critical Care Associates of Baltimore

Status

Completed

Last Update Posted

Apr 27, 2023Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease
Asthma

Interventions

Respimetrix flow-volume monitoring device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 27, 2020Actual

Primary Completion Date

Apr 25, 2022Actual

Completion Date

Apr 25, 2022Actual

First Submitted Date

Jun 2, 2020

First Submission Date that Met QC Criteria

Jun 2, 2020

First Posted Date

Jun 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2023

Last Update Posted Date

Apr 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alan Schwartz, Principal Investigator, Pulmonary Critical Care Associates of BaltimorePrincipal Investigator

Lead Sponsor

Pulmonary Critical Care Associates of BaltimoreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Respimetrix flow-volume monitoring device	Diagnostic Test	The Respimetrix flow-volume monitoring device is being tested to validate its ability to measure Inspiratory Capacity

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pulmonary and Critical Care Associates Of Baltimore		Towson	Maryland	21286	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D001249	Asthma

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

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Browse Branches

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