Will there be guidance for spirometry tests specific to the study and patient population?
Not for this study. Whereas in disease modification studies the primary endpoint (FVC) is derived from the spirometry and hence it is critical to standardise its assessment, in this study it is a routine safety assessment and so there is no need for specific measures around its collection.
Which spirometry parameters are to be recorded in the CRF?
The parameters required for this study are forced vital capacity (FVC), forced expired volume in one second (FEV1), vital capacity (VC) and peak expiratory flow rate (PEFR). Lung function should be assessed by spirometry in accordance with the joint 2019 American Thoracic Society and European Respiratory Society Technical Update on Standardization of Spirometry.
