Exhalation delivery system with fluticasone improves quality of life and health status: pooled analysis of phase 3 trials NAVIGATE I and II
| العنوان: | Exhalation delivery system with fluticasone improves quality of life and health status: pooled analysis of phase 3 trials NAVIGATE I and II |
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| المؤلفون: | Sam Colman, Rodney J. Schlosser, Fulton Velez, Zachary M. Soler |
| المصدر: | International Forum of Allergy & Rhinology |
| بيانات النشر: | John Wiley and Sons Inc., 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | medicine.medical_specialty, intervention study, Health Status, Population, Population health, Placebo, law.invention, quality improvement, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Quality of life, law, Internal medicine, Surveys and Questionnaires, Post-hoc analysis, Immunology and Allergy, Medicine, Humans, 030223 otorhinolaryngology, education, Fluticasone, education.field_of_study, nasal polyps, business.industry, Minimal clinically important difference, Original Articles, 030228 respiratory system, Otorhinolaryngology, quality of life, Exhalation, Original Article, business, population health, medicine.drug |
| الوصف: | 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. |
| اللغة: | English |
| تدمد: | 2042-6984 2042-6976 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::96ddd1e0e9cd694f531f39d345ce8b4dTest http://europepmc.org/articles/PMC7818430Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....96ddd1e0e9cd694f531f39d345ce8b4d |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20426984 20426976 |
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