Centralized Spirometry
Spirometry is one of the most important clinical endpoints for any respiratory clinical trial. For ERT, the term standardized spirometry refers to each site receiving the exact same equipment with the same protocol specific software for a clinical trial. And centralized spirometry refers to the electronic transfer of the spirometry data to a centralized database, where spirometry overread is performed and feedback to the sites regarding the quality of the spirometry is given. Centralized spirometry should be standard for a sponsor developing new compounds for the treatment of asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis.
Why should centralized spirometry be standard?
In the study of respiratory drugs, the parameters FEV1 and FVC are the important spirometry values used to determine efficacy and safety of an experimental drug. However, like all other pulmonary function values, these parameters are subject to the great amount of variability inherent in the nature of the testing.
In general terms, the validity of spirometry values is highly dependent on the cooperation of the subject, the interaction of the subject with the study coordinator and the influences of the surrounding environment. The analysis of any parameter without considering these factors could result in faulty or erroneous conclusions. Inconclusive results waste time and money and ultimately may prevent the release of a promising compound or, in the worst case, release a compound that is harmful to society.
