Effect of Budesonide Added to Large-Volume, Low-pressure Saline Sinus Irrigation for Chronic Rhinosinusitis

Tait, Sarah; Kallogjeri, Dorina; Suko, Jasmina; Kukuljan, Sara; Schneider, John S.; Piccirillo, Jay F.

doi:10.1001/jamaoto.2018.0667

Cited by 58 publications

(83 citation statements)

References 31 publications

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“…Although the questionnaire may be a good resource for evaluating QOL in CF patients, it has not been validated for this purpose . As alluded to in the opening paragraph of the discussion, baseline SNOT‐20 scores in this cohort of patients are much lower than what is typically observed in standard CRS patients, in which average baseline SNOT‐22 scores are generally greater than 40 . This, in addition to the lack of a validated questionnaire to specifically target sinonasal QOL in the CF population, makes assessment of this patient population difficult, and highlights the importance of development of a sinus‐specific QOL instrument for use in the CF population.…”

Section: Discussionmentioning

confidence: 93%

Ivacaftor improves rhinologic, psychologic, and sleep‐related quality of life in G551D cystic fibrosis patients

McCormick

Cho

Lampkin

et al. 2018

Int Forum Allergy Rhinol

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Background Ivacaftor is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator that improves pulmonary function in cystic fibrosis (CF) patients with at least 1 copy of the G551D CFTR mutation. The purpose of this study is to evaluate the impact of ivacaftor on chronic rhinosinusitis (CRS) symptoms in this population. Methods The G551D Observational (GOAL) study was a multicenter prospective cohort study enrolling CF patients ≥6 years with at least 1 G551D mutation. Subjects were provided 20‐item Sino‐Nasal Outcome Test (SNOT‐20) questionnaires prior to ivacaftor therapy and at 1, 3, and 6 months afterward. The impact on rhinologic (R), psychological (P), sleep (S), and ear/facial (E) quality of life (QOL) domains was evaluated separately. Results Of 153 subjects, 129 (84%) completed all questionnaires. Typical baseline symptom burden was low (75% with scores <1) and degree of improvement (ie, reduced scores) was greater with higher baseline scores. SNOT‐20 decreased, reflecting improvement, at all follow‐up intervals (1 month: [mean change ± standard deviation] –0.25 ± 0.53, p < 0.01; 3 months; –0.29 ± 0.58, p < 0.01; 6 months: –0.21 ± 0.58, p = 0.02), but less than the prespecified minimal clinically important difference (0.8). Significant improvement was observed at 1, 3, and 6 months in the R domain (1 month: –0.24, p < 0.01; 3 months: –0.34, p < 0.01; 6 months: –0.25, p < 0.01) and P domain (1 month: –0.25, p < 0.01; 3 months: –0.32, p < 0.01; 6 months: –0.26, p < 0.01), and 1 and 3 months in the S domain (1 months: –0.35, p < 0.01; 3 months: –0.32, p < 0.01; 6 months: –0.18, p = 0.07). There was no improvement in the E domain at any time point. Conclusion Ivacaftor improves QOL in the R, P, and S domains in G551D CF patients, although QOL instruments validated for CRS may not translate well to CF CRS patients because symptom burden was surprisingly low.

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Section: Discussionmentioning

confidence: 93%

Ivacaftor improves rhinologic, psychologic, and sleep‐related quality of life in G551D cystic fibrosis patients

McCormick

Cho

Lampkin

et al. 2018

Int Forum Allergy Rhinol

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“…Tait et al also performed a double‐blinded, placebo‐controlled trial comparing budesonide irrigations vs saline irrigations in 61 patients. All patients used a 240‐mL irrigation once daily and were evaluated after 30 days by the SNOT‐22, LK grading, and a modified Clinical Global Impressions scale.…”

Section: Resultsmentioning

confidence: 99%

“…Other studies, however, consisted of either completely nonsurgical cohorts, or ones in which surgical extent was inconsistently described. In particular, Tait et al found that patients who did not undergo surgery fared better than those who did have surgery. Although the difference did not reach statistical significance, it does highlight the question of whether all sinus surgery is equal.…”

Section: Discussionmentioning

confidence: 99%

“…Although dose may not play a significant role, the ability of the medication to reach the sinuses via large‐volume lavage is essential. Three studies used large‐volume (240 mL) corticosteroid irrigations with 0.5‐1 mg of budesonide vs saline and 2 of the 3 studies reported significant improvement in symptoms and clinical scoring . The study without improvement used 1 mg/d budesonide for 1 month.…”

Section: Discussionmentioning

confidence: 99%

“…Multiple corticosteroids were used in the aforementioned studies, including mometasone, fluticasone, betamethasone, and budesonide . Fluticasone and betamethasone were not studied for effectiveness of treatment, but were instead evaluated for safety.…”

Section: Discussionmentioning

confidence: 99%

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Topical corticosteroid irrigations in chronic rhinosinusitis

Grayson

Harvey

2019

Int Forum Allergy Rhinol

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Background Chronic rhinosinusitis (CRS) has previously been thought to occur secondary to infectious or obstructive etiologies. However, in recent years, primary CRS has been more discretely defined as diffuse airway inflammation, similar to asthma. Adequate medical and surgical therapy are needed to control the inflammation. Our purpose in this study was to evaluate the efficacy and safety of topical corticosteroid treatment. Methods A focused literature review was conducted and we identified 11 original articles from the years 2013‐2018 evaluating safety or efficacy of topical corticosteroid irrigations. Results Eleven articles were identified. One study found significant benefit between corticosteroid irrigations versus corticosteroid sprays. Two studies found significant benefit between corticosteroid irrigations compared to saline irrigations while two did not. One study found significant improvement in certain patient populations when using corticosteroid irrigations compared to no irrigation. Five studies found no significant increase in risk of adverse side effects with the use of topical corticosteroids. Conclusion Many factors are associated with efficacious and adequate treatment of primary CRS. The pathology must be correctly diagnosed and be inflammatory in nature. The treatment paradigm should include wide and complete endoscopic sinus surgery for the adequate delivery of topical therapy. Topical therapy should be delivered in large‐volume, low‐pressure devices with adequate dosing. Although there is some systemic absorption, multiple studies have demonstrated that long‐term, daily use of topical corticosteroids does not increase intraocular pressure, suppress the hypothalamic‐pituitary‐adrenal axis, or increase the risk of subcapsular cataracts. Therefore, topical corticosteroid irrigations should be considered a part of first‐line medical treatment in postsurgical CRS patients.

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Building the Evidence for Corticosteroid Irrigation Therapy in Chronic Rhinosinusitis

Hwang

2018

JAMA Otolaryngol Head Neck Surg

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Effect of Budesonide Added to Large-Volume, Low-pressure Saline Sinus Irrigation for Chronic Rhinosinusitis

Abstract: ClinicalTrials.gov Identifier: NCT02696850.

Cited by 58 publications

References 31 publications

Ivacaftor improves rhinologic, psychologic, and sleep‐related quality of life in G551D cystic fibrosis patients

Ivacaftor improves rhinologic, psychologic, and sleep‐related quality of life in G551D cystic fibrosis patients

Topical corticosteroid irrigations in chronic rhinosinusitis

Building the Evidence for Corticosteroid Irrigation Therapy in Chronic Rhinosinusitis

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