Generalizability of Randomised Controlled Trial Eligibility Criteria in Refractory Chronic Cough

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Background: Recruitment into randomized controlled trials(RCT) maybe limited by restrictive eligibility criteria. Refractory Chronic Cough(RCC) trials often require objective and subjective cough criteria. Objectives: Quantify the proportion of RCC patients meeting eligibility criteria based on cough severity visual analogue scale(VAS)(≥40mm on 0-100mm) or 24-hr cough frequency (0-<10,≥10-<20,>20 cough/hr)pre-and post-treatment Methods: Prospective observational single-center cohort study with 24-hr cough frequency, VAS assessment pre-post treatment following ERS cough guidelines. Results: 62 patients were recruited:mean(SD) age 57.7(13.8), 64% female, cough duration 9.9(9.8) yrs, VAS 62.0mm(22.5), LCQ 10.7(3.0). At baseline, 51(82%) met VAS≥40mm; post-treatment, 31(50%)(Fig1A). ≥20 coughs/hr: 26 patients(42%) at baseline, to 20(32%) post-treatment, and 16patients (26%) at both time points(Fig1B). ≥10-<20 coughs/hr: 15 patients(24%) at baseline, 2 were stable, 9 improved to <10 coughs/hr, 4 worsened to ≥20 coughs/hr. 0-<10 coughs/hr:21 patients pre-treatment(34%) mostly remained low. Patients with>20 coughs/hr were older, predominantly female, had longer cough duration, higher VAS, and more triggers. Conclusion: This study suggest about 50% may be eligible on VAS criteria, but this is reduced with an objective cough frequency cut-off. This data highlights the need to balance inclusion thresholds with generalizability. erj;66/suppl_69/PA459/F1 F1 F1

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