International forum of allergy & rhinology · 2020
Exhalation delivery system with fluticasone improves quality of life and health status: pooled analysis of phase 3 trials NAVIGATE I and II.
Клиническое исследование III фазыСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Soler Zachary M, Colman Sam, Velez Fulton F, Schlosser Rodney J
Аннотация
BACKGROUND: Chronic rhinosinusitis with or without nasal polyps (CRSwNP/CRSsNP) seriously impairs health-related quality of life (HRQoL). This analysis describes the impact of the exhalation delivery system with fluticasone (EDS-FLU) on HRQoL, assessed by the 36-item Short-Form Health Survey version 2 (SF-36v2), and on utilities, assessed via the Short-Form 6-Dimension (SF-6D), in patients with CRSwNP.
METHODS: Post hoc analysis of pooled randomized clinical trial data (NAVIGATE I and II; N = 643) to examine change from baseline in SF-36v2 and SF-6D at end-of-double-blind (EODB: 16 weeks) and end-of-open-label (EOOL: 24 weeks; following 8 weeks of open-label treatment) for EDS-FLU vs placebo (EDS-PBO). Baseline characteristics predictive of change in SF-36 and SF-6D scores were assessed.
RESULTS: Mean baseline SF-36v2 scores were below population norms. At EODB, mean improvement was greater for all SF-36v2 domain and component scores with EDS-FLU (range: 2.9 [physical functioning] to 5.11 [bodily pain {BP}]) vs EDS-PBO (range: 0.81 [mental health] to 2.87 [BP]) (each comparison p < 0.01); physical and mental component score improvements within the EDS-FLU group exceeded the minimal clinically important difference (MCID). Clinically meaningful and statistically significant improvements in SF-6D utility scores were seen in EDS-FLU-treated patients compared to EDS-PBO-treated patients (0.058 vs 0.023, respectively, p < 0.001). At EOOL, SF-36v2 and SF-6D mean scores were at or above population norms, with clinically meaningful and statistically significant improvements from baseline.
CONCLUSION: In this pooled analysis of 2 large pivotal EDS-FLU trials, health domain and health utilities improvements were significantly greater with EDS-FLU than EDS-PBO and were comparable to population norms.
METHODS: Post hoc analysis of pooled randomized clinical trial data (NAVIGATE I and II; N = 643) to examine change from baseline in SF-36v2 and SF-6D at end-of-double-blind (EODB: 16 weeks) and end-of-open-label (EOOL: 24 weeks; following 8 weeks of open-label treatment) for EDS-FLU vs placebo (EDS-PBO). Baseline characteristics predictive of change in SF-36 and SF-6D scores were assessed.
RESULTS: Mean baseline SF-36v2 scores were below population norms. At EODB, mean improvement was greater for all SF-36v2 domain and component scores with EDS-FLU (range: 2.9 [physical functioning] to 5.11 [bodily pain {BP}]) vs EDS-PBO (range: 0.81 [mental health] to 2.87 [BP]) (each comparison p < 0.01); physical and mental component score improvements within the EDS-FLU group exceeded the minimal clinically important difference (MCID). Clinically meaningful and statistically significant improvements in SF-6D utility scores were seen in EDS-FLU-treated patients compared to EDS-PBO-treated patients (0.058 vs 0.023, respectively, p < 0.001). At EOOL, SF-36v2 and SF-6D mean scores were at or above population norms, with clinically meaningful and statistically significant improvements from baseline.
CONCLUSION: In this pooled analysis of 2 large pivotal EDS-FLU trials, health domain and health utilities improvements were significantly greater with EDS-FLU than EDS-PBO and were comparable to population norms.