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Connect Lung Outcomes With Bronchodilator Use (CLOUD)

P

Pulmonary and Critical Care Associates of Baltimore (PCCAB)

Status

Completed

Conditions

Asthma
Chronic Obstructive Pulmonary Disease

Treatments

Diagnostic Test: Respimetrix flow-volume monitoring device

Study type

Observational

Funder types

Other

Identifiers

NCT04417842
V1 21APR2020

Details and patient eligibility

About

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.

Full 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).

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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