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Related Experiment Videos

[Assessment and outcome parameters in COPD].

R Dierkesmann¹, A Gillissen, J Lorenz

¹Die Institutsangaben sind am Ende des Beitrags gelistet.

Pneumologie (Stuttgart, Germany)

|January 13, 2009

Summary

This summary is machine-generated.

For chronic obstructive pulmonary disease (COPD) trials, forced expiratory volume in one second (FEV1) remains the primary outcome. No single parameter adequately replaces FEV1 for assessing COPD, though others offer supplementary data.

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Area of Science:

Pulmonary Medicine
Clinical Trials
Respiratory Research

Background:

Defining a standard outcome parameter for pharmacological trials in COPD has been a challenge.
This review evaluates commonly used parameters for their suitability in COPD assessment and outcomes.

Purpose of the Study:

To identify and evaluate potential standard outcome parameters for COPD clinical trials.
To determine the most appropriate measures for assessing treatment efficacy in COPD.

Main Methods:

A comprehensive review of existing scientific literature was conducted.
Analysis focused on parameters frequently utilized in COPD research.

Main Results:

Forced expiratory volume in one second (FEV1) is recommended as the primary outcome measure.
Additional parameters like FVC, IC/TLC, RV/TLC, K(co), PaO2, and PaCO2 provide valuable supplementary data.
FEV1 does not surrogate for dyspnea, quality of life, or exercise tolerance, necessitating separate assessments.
Exacerbation frequency/severity and mortality are crucial for long-term trials.
Complex indices like the BODE index may offer advantages over single variables.

Conclusions:

Currently, no single parameter sufficiently substitutes FEV1 as the standard for COPD assessment and outcomes.
FEV1 remains the most reliable primary outcome measure in COPD trials.
Further evaluation is needed for other parameters to potentially serve as alternatives or complements to FEV1.