SESSION TITLE: COPD Diagnosis & Evaluation Posters
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PM
PURPOSE: Results of bronchodilator responses were analyzed by statistical evaluation of intra-individual responses compared to the population-based American Thoracic Society (ATS) positive criteria requiring increases in one-second forced expiratory volume (ΔFEV1) of ≥200 mL and ≥12%.
METHODS: Spirometry data from Visit 1 of 84 COPD (GOLD 1 and 2) patients in a multicenter study (Boehringer Ingelheim, NCT01072396) were obtained from 11 North American laboratories. Each performed satisfactory measures of FEV1 before and after receiving albuterol (400 µg ProAir). Three highest pre- and three highest post-FEV1 values were compared (positives were p=0.05 for rank order tests and p<0.05 for unpaired one-tailed t-tests). ATS criteria were separately applied.
RESULTS: Eleven of 84 patients decreased or did not change their FEV1 while 73 had FEV1 increases (10-100ml in 16, 110-200ml in 25, 210-300ml in 19, 310-400ml in 8, and ≥410ml in 5); FEV1% increases were 0.01-3% in 7, 3.01-6% in 11, 6.01-12% in 27, 12.01-21% in 18, and >21% in 10. Overall mean and maximal ΔFEV1 differed by only 1±34mL. Statistically significant increases where FEV1≥100mL and FEV1≥6% occurred in 61 and 62 patients, respectively. In contrast, only 24 patients met both ATS criteria: 4 more had responses ≥12% but not ≥200mL while 11 others had ≥200mL but not ≥12%. The number of positive responders by the criteria (≥6% or ≥100mL and p<0.05) differed significantly from those by either ATS criteria (Chi square p<0.0001).
CONCLUSIONS: ATS guidelines define positive BD response based on the variability of populations that differ markedly in age, size, and health and, therefore, in pre-BD FEV1. Regardless of their inherent validity, population values may not be suitable for evaluating BD responsiveness in individual patients. For evaluating individual bronchodilator responsiveness we propose the use of the criteria of ΔFEV1 ≥6% orΔFEV1 ≥100mL and p<0.05 in an unpaired one-tailed t-test.
CLINICAL IMPLICATIONS: Better criteria for bronchodilator responsiveness may lead to better therapy for our patients.
DISCLOSURE: Janos Porszasz: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer-Ingelheim: consultant and steering committee member for the study Heather Paden: Employee: Boehringer Ingelheim employee Richard Casaburi: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer-Ingelheim: consultant, speakers' bueau, attended meetings The following authors have nothing to disclose: James Hansen
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