Impact of Baseline Nasal Polyp Size and Previous Surgery on Efficacy of Fluticasone Delivered with a Novel Device: A Subgroup Analysis

Djupesland, Per G.; Vlckova, Ingrid; Hewson, G.

doi:10.2500/ajra.2010.24.3516

Cited by 7 publications

(7 citation statements)

References 32 publications

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“…Exhalation delivery systems (EDSs) utilize a mechanism for intranasal drug delivery that has been shown to deliver medication high and deep to superior/posterior sites in the nasal passages, including the OMC . An EDS with fluticasone (EDS‐FLU) offers potential to improve treatment efficacy by enabling placement of a high‐potency steroid (fluticasone propionate) on sites of chronic inflammation in CRS that are not effectively or consistently accessed with standard nasal delivery approaches during chronic outpatient care (Fig. ).…”

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confidence: 99%

EXHANCE‐12: 1‐year study of the exhalation delivery system with fluticasone (EDS‐FLU) in chronic rhinosinusitis

Palmer

Jacobson

Messina

et al. 2018

Int Forum Allergy Rhinol

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BackgroundInadequate efficacy of current intranasal steroids in chronic rhinosinusitis (CRS) is attributable to ineffective and/or inconsistent drug delivery to target anatomic sites. A new exhalation delivery system with fluticasone (EDS‐FLU) may improve outcomes by significantly increasing superior/posterior corticosteroid delivery. A study was conducted to assess the long‐term efficacy and safety outcomes of EDS‐FLU in individuals with CRS.MethodsThis was a 12‐month, multicenter, single‐arm study evaluating the safety and efficacy of EDS‐FLU 372 μg twice daily in CRS patients (with [n = 34] or without [n = 189] nasal polyps [NP]). Efficacy assessments by serial nasal endoscopy and patient report included: 22‐item Sino‐Nasal Outcome Test (SNOT‐22), NP grade, standardized surgical indicator assessment, Lund‐Kennedy score, and Patient Global Impression of Change. Adverse event (AE) evaluations included nasal endoscopy. Additional safety and efficacy outcomes were assessed.ResultsOf 223 patients who received EDS‐FLU, 96% reported prior corticosteroid use and 29% prior sinus surgery. The EDS‐FLU AE profile was similar to conventional intranasal steroids studied in similar populations. Most patients (87%) reported symptom improvement. Through 12 months, mean SNOT‐22 scores improved by −21.5 and −21.1 for CRS with and without NP, respectively. Among patients with NP, 54.2% had polyp elimination in at least 1 nostril and 83.3% had ≥1‐point improvement in polyp grade.ConclusionOver 1 year of treatment in CRS with and without NP, EDS‐FLU 372 μg twice daily was well tolerated and produced improvements across a broad range of objective and subjective measures. EDS‐FLU may be a desirable new option for patients with this condition.

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confidence: 99%

EXHANCE‐12: 1‐year study of the exhalation delivery system with fluticasone (EDS‐FLU) in chronic rhinosinusitis

Palmer

Jacobson

Messina

et al. 2018

Int Forum Allergy Rhinol

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“…Overall, findings from our study suggest that PNIF and rhinomanometry can provide objective measures of nasal ventilation in almost all sinusitis and polyp (except patients with severe size 4 polyps). Published studies have presented PNIF and rhinomanometry values to compare polyp behaviour over time or after treatment 23,[28][29][30][31] .…”

Section: Discussionmentioning

confidence: 99%

“…These scales are simple to apply and easy to compare in different studies. Although polyp size may vary over time and does not predict treatment success, patients often tend to present with small polyps regardless of when they present for evaluation 23,29,30 . Our patients also had predominantly small polyps.…”

Section: Discussionmentioning

confidence: 99%

“…In summary, NP is a socially relevant disease and new disease biomarkers must be identified to help manage treatment in a personalized manner. Few studies have reported results from PNIF and/or rhinomanometry in NP patient cohorts 23,[28][29][30][31] and, to the best of our knowledge, none have specifically tried to measure the effect of polyp size on those techniques. In light of the previous considerations, our aim is to evaluate if polyp size alters, or not, PNIF and rhinomanometry results, which has implications in the validity of testing those techniques as NP disease biomarkers in the future.…”

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The potential role of peak nasal inspiratory flow to evaluate active sinonasal inflammation and disease severity

Araújo-Martins

Brás-Geraldes

Neuparth

2020

Sci Rep

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Although the pathophysiology of nasal polyposis is incompletely understood, rhinologists have seldom studied it with rhinomanometry or peak nasal inspiratory flow (PNIF) due to technical limitations and the perception that polyp size might impair reproducibility and the usefulness of recordings. The objective of this study is to assess how measures of rhinomanometry and PNIF relate to disease activity. Nineteen patients with polyps, 15 patients with chronic sinusitis without polyps and 11 negative controls were evaluated with active anterior rhinomanometry and PNIF. Sinusitis and polyp patients were re-evaluated after medical treatment. Polyp patients had the highest median Lund-Mackay score (14) and a median Johansen score of 1. PNIF and its variation after treatment were also lowest in this group (median 90 L/min before and after treatment; median variation of 0 L/min). Nasal resistance was similar between groups, and only correlated with Johansen score (Spearman = 0.517, p = 0.048) after treatment. Our study suggests that evaluating polyp patients using rhinomanometry and PNIF may provide useful and reproducible data. Several findings considered together suggest that polyp size is not the main determinant of nasal functional changes in these patients, warranting further studies to verify whether PNIF changes reflect sinus inflammation or merely airway obstruction.

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“…In contrast, no liquid was observed to escape from the nasal/sinus spaces following drug administration by EDS into nasal casts, indicating that the full dose (372 µg [93 µg per actuation], XHANCE) remains in the nasal passages and sinus cavities. Adjusting for the 1.7× higher glucocorticoid receptor binding affinity (20) of fluticasone propionate, 372 μg is a comparatively high dose in the target region (16,17,21) .…”

Section: Discussionmentioning

confidence: 99%

Deposition of drugs in the nose and sinuses with an exhalation delivery system vs conventional nasal spray or high-volume irrigation in Draf II/III post-surgical anatomy

Djupesland

Messina

Palmer

2019

Rhin

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Background: Endoscopic sinus surgery is often performed to improve delivery of topical medication into sinus cavities. Intranasal steroids are guideline recommended in post-surgical patients, and experiments with cadavers suggest that surgery improves delivery of drug into sinuses. Exhalation delivery systems (EDS) use a new mechanism for intranasal delivery and have been shown to reach superior/posterior regions of the nasal cavity better than nasal sprays in unoperated patients. Methods: Silicone casts of the nasal cavity and sinuses from a patient after Draf II, and then Draf III, were made from high-resolution computed tomography (CT) data using 3D printing. Internal surfaces were coated with liquid-sensitive, color-changing gel. Color changes were evaluated following conventional nasal spray delivery (0.1 mL × 2) (Nasonex®), EDS delivery (0.1 mL × 2) (XHANCE™), and high-volume, low-flow (HVLF) delivery (≈80 mL) with head tilted either 45° or 90°. Results: Conventional nasal spray deposited liquid only in anterior nasal segments. EDS deposited liquid throughout the nasal cavity, in surgically opened ethmoid and maxillary spaces, at entrances of the frontal sinuses in Draf II geometry, and into frontal sinuses in Draf III. Tilted 45°, HVLF delivery enters the maxillary sinuses but not the frontal sinuses or the ethmoid region. At full 90° inclination, HVLF delivery reaches most of the frontal and maxillary sinuses but not the roof and posterior wall of the ethmoid region. Conclusions: HVLF and EDS produced a deep intranasal/intrasinal deposition in the silicone cast compared with conventional nasal spray delivery; both deposited liquid inside the surgically opened sinuses. HVLF offers the benefit of lavage, whereas EDS may be more efficient and convenient.

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Impact of Baseline Nasal Polyp Size and Previous Surgery on Efficacy of Fluticasone Delivered with a Novel Device: A Subgroup Analysis

Cited by 7 publications

References 32 publications

EXHANCE‐12: 1‐year study of the exhalation delivery system with fluticasone (EDS‐FLU) in chronic rhinosinusitis

EXHANCE‐12: 1‐year study of the exhalation delivery system with fluticasone (EDS‐FLU) in chronic rhinosinusitis

The potential role of peak nasal inspiratory flow to evaluate active sinonasal inflammation and disease severity

Deposition of drugs in the nose and sinuses with an exhalation delivery system vs conventional nasal spray or high-volume irrigation in Draf II/III post-surgical anatomy

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