Efficacy of EDS-FLU for Chronic Rhinosinusitis : Two Randomized Controlled Trials (ReOpen1 and ReOpen2)
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved..
BACKGROUND: Chronic rhinosinusitis (CRS) is a prevalent inflammatory disease. No medications are Food and Drug Administration-approved for the most common form, CRS without nasal polyps (also called "chronic sinusitis"). Novel biomechanics of the exhalation delivery system deliver fluticasone (EDS-FLU; XHANCE) to sinonasal areas above the inferior turbinate, especially sinus drainage pathways not reached by standard-delivery nasal sprays.
OBJECTIVE: Assess EDS-FLU efficacy for CRS (irrespective of nasal polyps).
METHODS: Two randomized, EDS-placebo-controlled trials in adults with CRS irrespective of polyps (ReOpen1) or exclusively without polyps (ReOpen2) were conducted at 120 sites in 13 countries. Patients received EDS-FLU 1 or 2 sprays/nostril, or EDS-placebo, twice daily for 24 weeks. Coprimary measures were composite symptom score through week 4 and ethmoid/maxillary sinus percent opacification by computed tomography at week 24.
RESULTS: ReOpen1 (N = 332) composite symptom score least-squares mean change for EDS-FLU 1 or 2 sprays/nostril versus EDS-placebo was -1.58 and -1.60 versus -0.62 (P < .001, P < .001); ReOpen2 (N = 223), -1.54 and -1.74 versus -0.81 (P = .011, P = .001). In ReOpen1, sinus opacification least-squares mean change for EDS-FLU 1 or 2 sprays/nostril versus EDS-placebo was -5.58 and -6.20 versus -1.60 (P = .045, P = .018), and in ReOpen2, -7.00 and -5.14 versus +1.19 (P < .001, P = .009). Acute disease exacerbations were reduced by 56% to 66% with EDS-FLU versus EDS-placebo (P = .001). There were significant, and similar magnitude, symptom reductions in patients using standard-delivery nasal steroid products just before entering the study (P < .001). Adverse events were similar to standard-delivery intranasal steroids.
CONCLUSIONS: EDS-FLU is the first nonsurgical treatment demonstrated to reduce symptoms, intrasinus opacification, and exacerbations in replicate randomized clinical trials in CRS, regardless of polyp status.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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| Enthalten in: |
The journal of allergy and clinical immunology. In practice - 12(2024), 4 vom: 08. Apr., Seite 1049-1061 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Palmer, James N [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 09.04.2024 Date Revised 13.04.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jaip.2023.12.016 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM367345048 |
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| 100 | 1 | |a Palmer, James N |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy of EDS-FLU for Chronic Rhinosinusitis |b Two Randomized Controlled Trials (ReOpen1 and ReOpen2) |
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| 500 | |a Date Revised 13.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: Chronic rhinosinusitis (CRS) is a prevalent inflammatory disease. No medications are Food and Drug Administration-approved for the most common form, CRS without nasal polyps (also called "chronic sinusitis"). Novel biomechanics of the exhalation delivery system deliver fluticasone (EDS-FLU; XHANCE) to sinonasal areas above the inferior turbinate, especially sinus drainage pathways not reached by standard-delivery nasal sprays | ||
| 520 | |a OBJECTIVE: Assess EDS-FLU efficacy for CRS (irrespective of nasal polyps) | ||
| 520 | |a METHODS: Two randomized, EDS-placebo-controlled trials in adults with CRS irrespective of polyps (ReOpen1) or exclusively without polyps (ReOpen2) were conducted at 120 sites in 13 countries. Patients received EDS-FLU 1 or 2 sprays/nostril, or EDS-placebo, twice daily for 24 weeks. Coprimary measures were composite symptom score through week 4 and ethmoid/maxillary sinus percent opacification by computed tomography at week 24 | ||
| 520 | |a RESULTS: ReOpen1 (N = 332) composite symptom score least-squares mean change for EDS-FLU 1 or 2 sprays/nostril versus EDS-placebo was -1.58 and -1.60 versus -0.62 (P < .001, P < .001); ReOpen2 (N = 223), -1.54 and -1.74 versus -0.81 (P = .011, P = .001). In ReOpen1, sinus opacification least-squares mean change for EDS-FLU 1 or 2 sprays/nostril versus EDS-placebo was -5.58 and -6.20 versus -1.60 (P = .045, P = .018), and in ReOpen2, -7.00 and -5.14 versus +1.19 (P < .001, P = .009). Acute disease exacerbations were reduced by 56% to 66% with EDS-FLU versus EDS-placebo (P = .001). There were significant, and similar magnitude, symptom reductions in patients using standard-delivery nasal steroid products just before entering the study (P < .001). Adverse events were similar to standard-delivery intranasal steroids | ||
| 520 | |a CONCLUSIONS: EDS-FLU is the first nonsurgical treatment demonstrated to reduce symptoms, intrasinus opacification, and exacerbations in replicate randomized clinical trials in CRS, regardless of polyp status | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a CRS with nasal polyps | |
| 650 | 4 | |a CRS without nasal polyps | |
| 650 | 4 | |a Chronic rhinosinusitis | |
| 650 | 4 | |a Exhalation delivery system with fluticasone | |
| 650 | 4 | |a Nasal corticosteroids | |
| 650 | 4 | |a Randomized clinical trials | |
| 650 | 4 | |a Sinus opacification | |
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| 650 | 7 | |a Steroids |2 NLM | |
| 650 | 7 | |a xhance |2 NLM | |
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| 700 | 1 | |a Ow, Randall A |e verfasserin |4 aut | |
| 700 | 1 | |a Patel, Zara M |e verfasserin |4 aut | |
| 700 | 1 | |a Peters, Anju T |e verfasserin |4 aut | |
| 700 | 1 | |a Sacks, Harry |e verfasserin |4 aut | |
| 700 | 1 | |a Schlosser, Rodney J |e verfasserin |4 aut | |
| 700 | 1 | |a Sindwani, Raj |e verfasserin |4 aut | |
| 700 | 1 | |a Soler, Zachary M |e verfasserin |4 aut | |
| 700 | 1 | |a White, Andrew A |e verfasserin |4 aut | |
| 700 | 1 | |a Wise, Sarah K |e verfasserin |4 aut | |
| 700 | 1 | |a Mahmoud, Ramy A |e verfasserin |4 aut | |
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