Exhaled Carbon Monoxide (eCO) for Diffusing Capacity (DLCO) Correction

Status Completed

Clinical Trial Summary

The purpose of this study is to check the accuracy of a procedure called exhaled carbon monoxide (eCO) testing. Exhaled carbon monoxide is used by physicians to help assess breathing in people with conditions like asthma and emphysema. eCO may be used to correct another breathing test (called diffusing capacity, or DLCO). Blood collection is usually required to correct the DLCO, so validation of the eCO test may help avoid that blood collection.

Clinical Trial Description

The purpose of this study is to check the accuracy of a procedure called exhaled carbon monoxide (eCO) testing. Exhaled carbon monoxide is used by physicians to help assess breathing in people with conditions like asthma and emphysema. 100 subjects who are at least 18 years of age will be invited to participate. The first 50 subjects (Part 1) must have had pulmonary function testing (spirometry, diffusing capacity and CO-oximetry) for clinical reasons ordered by their own physician in order to enroll. The second 50 subjects (Part 2) may undergo this testing as part of the study. Participation requires 1 visit, during which subjects will undergo breathing tests, have blood collected, and answer 3 questions. The number of breathing tests will depend on which part of the study subjects are in. Subjects participating in Part 1 of the study will undergo 2-4 additional diffusing capacity (breathing) tests. (Clinical tests require 2-4 tests. This study requires 6. The number of research tests done depends on the number of clinical tests done. Subjects participating in Part 2 of the study who have not had clinical breathing tests ordered by their physician will undergo 1 spirometry (breathing) test (3-8 blows into a tube), 6 diffusing capacity (breathing tests), and blood draw. All subjects will undergo eCO testing (blowing into a machine) before the breathing tests and after the breathing tests. The visit in Part 1 of the study will take about 30 minutes. The visit in Part 2 of the study will take about 30 minutes for subjects who have undergone clinical breathing tests recently, and about 1 ½ hours for those who must undergo breathing tests for the research. Subjects will also have their pulse oximetry (using a standard finger clip) performed at the same time as each eCO testing. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Lung Diseases

Clinical Trial Details

NCT number	NCT01126047
Study type	Interventional
Source	University of California, Los Angeles
Contact
Status	Completed
Phase	N/A
Start date	May 2010
Completion date	November 2011

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.