biostudies-literatureUnknown9(1)Topole E<h4>Rationale</h4>Acquiring high-quality spirometry data in clinical trials is important, particularly when using forced expiratory volume in 1 s or forced vital capacity as primary end-points. In addition to quantitative criteria, the American Thoracic Society (ATS)/European Respiratory Society (ERS) standards include subjective evaluation which introduces inter-rater variability and potential mistakes. We explored the value of artificial intelligence (AI)-based software (ArtiQ.QC) to assess spirometry quality and compared it to traditional over-reading control.<h4>Methods</h4>A random sample of 2000 sessions (8258 curves) was selected from Chiesi COPD and asthma trials (n=1000 per disease). Acceptability using the 2005 ATS/ERS standards was determined by over-reader review and by ArtiQ.QERJ open research00292-2022https://www.ebi.ac.uk/biostudies/studies/S-EPMC9907146biostudies-literatureArtificial intelligence based software facilitates spirometry quality control in asthma and COPD clinical trials.PMC9907146Biondaro SStanojevic SRay KMontagna ICorradi MGraham BDas NTopole ECorre STopalovic MfalseArtificial intelligence based software facilitates spirometry quality control in asthma and COPD clinical trials.<h4>Rationale</h4>Acquiring high-quality spirometry data in clinical trials is important, particularly when using forced expiratory volume in 1 s or forced vital capacity as primary end-points. In addition to quantitative criteria, the American Thoracic Society (ATS)/European Respiratory Society (ERS) standards include subjective evaluation which introduces inter-rater variability and potential mistakes. We explored the value of artificial intelligence (AI)-based software (ArtiQ.QC) to assess spirometry quality and compared it to traditional over-reading control.<h4>Methods</h4>A random sample of 2000 sessions (8258 curves) was selected from Chiesi COPD and asthma trials (n=1000 per disease). Acceptability using the 2005 ATS/ERS standards was determined by over-reader review and by ArtiQ.Q2023-01-01T00:00:00Z2023 Jan2025-04-19T20:51:21.995Z2025-04-19T20:51:21.995ZS-EPMC99071463677648310.1183/23120541.00292-2022