Nasal irrigation with corticosteroids in Brazil: the clinical response of 1% compounded budesonide drops and betamethasone cream

Abstract Introduction: High-volume corticosteroid nasal irrigation is a treatment option in patients with chronic rhinosinusitis. In Brazil, alternatives are used to optimize its cost and popularize its use, such as 1% compounded budesonide drops or betamethasone cream, and it is necessary to study these treatment modalities. Objective: To evaluate the clinical response of nasal irrigation with 1% compounded budesonide drops or betamethasone cream compared to nasal sprays utilized in patients with chronic rhinosinusitis. Methods: This was a retrospective observational study with 257 patients. One hundred and eight patients using corticosteroid nasal irrigation (292 treatment cycles) and 149 using corticosteroid nasal spray (300 treatment cycles) were included. Evaluation of subjective improvement, adverse events, exacerbations, and objective assessments with SNOT-22 and Lund-Kennedy endoscopic score were performed, in addition to sub-analyses related to nasal polyps and previous surgery. Results: Corticosteroid nasal irrigation and corticosteroid nasal spray improved the Lund-Kennedy endoscopic score, with more adverse events in the corticosteroid nasal irrigation group. Previous surgery increased corticosteroid nasal irrigation improvement, with greater subjective improvement and fewer exacerbations. 1% compounded budesonide drops were better than betamethasone cream in the Lund-Kennedy endoscopic score, with fewer adverse events. A 1,000 μg dose of 1% compounded budesonide drops was more effective than 500 μg. Conclusion: Corticosteroid nasal irrigation was effective in improving the Lund-Kennedy endoscopic score in chronic rhinosinusitis, especially in patients with nasal polyps and previous surgery, in addition to promoting a higher rate of subjective improvement and fewer exacerbations than corticosteroid nasal spray, but with more adverse events. 1% compounded budesonide drops improved the Lund-Kennedy endoscopic score with fewer adverse events than betamethasone cream, particularly at higher doses (1000 μg).

A phase II randomized trial to evaluate the long-term (12-week) efficacy and safety of OC-01 (varenicline solution) nasal spray for dry eye disease: The MYSTIC study.

PURPOSE: Dry eye disease is characterized by loss of tear film stability. OC-01 (varenicline solution) is a small-molecule nicotinic acetylcholine receptor agonist administered as a nasal spray that stimulates tear production. METHODS: In MYSTIC (NCT03873246) patients aged ≥22 years with dry eye disease were randomized 1:1:1 to OC-01 0.03 mg, OC-01 0.06 mg, or vehicle (n = 41 per group), administered twice daily via intranasal spray, for 12 weeks (84 days). Primary efficacy endpoint was mean change from baseline in anesthetized Schirmer's test score (STS) in study eye at day (D) 84. RESULTS: Patients receiving OC-01 0.03 and 0.06 mg had statistically significantly increased tear production at D84 versus vehicle; least squares mean changes from baseline in STS were 10.8 mm and 11.0 mm for OC-01 0.03 and 0.06 mg, respectively. A trend toward a higher proportion of patients experiencing ≥10-mm improvement in STS from baseline was observed with OC-01 0.03 mg (36.6%; p > 0.05), and was significant for OC-01 0.06 mg (48.8%; p = 0.024), versus vehicle (24.4%). Non-ocular treatment-emergent adverse events (TEAEs) were reported by 21 patients; the most common was sneezing (OC-01 0.03 mg, 2 [4.9%]; OC-01 0.06 mg, 3 [7.3%]), with similar frequencies between treatment groups. No severe or serious TEAEs were reported. CONCLUSIONS: OC-01 (varenicline solution) nasal spray improved tear production in patients with dry eye disease over a long-term (12-week) period, and represents a receptor neuro-activator with a nasal route of administration that spares the ocular surface to stimulate tear production.

Nasal irrigation with corticosteroids in Brazil: the clinical response of 1% compounded budesonide drops and betamethasone cream.

INTRODUCTION: High-volume corticosteroid nasal irrigation is a treatment option in patients with chronic rhinosinusitis. In Brazil, alternatives are used to optimize its cost and popularize its use, such as 1% compounded budesonide drops or betamethasone cream, and it is necessary to study these treatment modalities. OBJECTIVE: To evaluate the clinical response of nasal irrigation with 1% compounded budesonide drops or betamethasone cream compared to nasal sprays utilized in patients with chronic rhinosinusitis. METHODS: This was a retrospective observational study with 257 patients. One hundred and eight patients using corticosteroid nasal irrigation (292 treatment cycles) and 149 using corticosteroid nasal spray (300 treatment cycles) were included. Evaluation of subjective improvement, adverse events, exacerbations, and objective assessments with SNOT-22 and Lund-Kennedy endoscopic score were performed, in addition to sub-analyses related to nasal polyps and previous surgery. RESULTS: Corticosteroid nasal irrigation and corticosteroid nasal spray improved the Lund-Kennedy endoscopic score, with more adverse events in the corticosteroid nasal irrigation group. Previous surgery increased corticosteroid nasal irrigation improvement, with greater subjective improvement and fewer exacerbations. 1% compounded budesonide drops were better than betamethasone cream in the Lund-Kennedy endoscopic score, with fewer adverse events. A 1,000 µg dose of 1% compounded budesonide drops was more effective than 500 µg. CONCLUSION: Corticosteroid nasal irrigation was effective in improving the Lund-Kennedy endoscopic score in chronic rhinosinusitis, especially in patients with nasal polyps and previous surgery, in addition to promoting a higher rate of subjective improvement and fewer exacerbations than corticosteroid nasal spray, but with more adverse events. 1% compounded budesonide drops improved the Lund-Kennedy endoscopic score with fewer adverse events than betamethasone cream, particularly at higher doses (1000 µg).

Effectiveness of fentanyl pectin nasal citrate in controlling episodes of breakthrough cancer pain triggered by routine radiotherapy procedures.

PURPOSE: The aim of the study was to evaluate the effectiveness of fentanyl pectin nasal spray (FPNS) in controlling procedural breakthrough cancer pain (BTCP) in advanced cancer patients undergoing radiotherapy. MATERIALS AND METHODS: This study involved 62 advanced cancer patients, with well-controlled background pain, who presented BTCP associated to routine radiotherapy procedures, treated with FPNS according to our protocol of administration. The BPE intensity was measured using a visual analog scale (VAS). RESULTS: The BTCP was triggered during the computed tomography simulation (79.3%) or treatment delivery (20.7%). Patients indicated a mean VAS of 8.8 (range 7-10) when attempting the procedure. After 4.5 min (range 2-10) of the first FPNS dose, the majority of patients (85.5%) indicated a VAS of 4.3 (range 2-6). 15.5% of the patients did not respond after 15 min; requiring a second dose. All these patients responded, reporting a mean VAS of 4.2 (range 4-6) after 3.0 min (range 2-5) of the second dose. None of the patients required a third dose, nor reported an AE after the administration of FPNS. CONCLUSIONS: In our knowledge, our study is the one of highest recruitment, and with the fastest response of BTCP treated with FPNS reported in advanced cancer patients undergoing radiotherapy. FPNS has proven to be highly effective in reducing the intensity of procedural BTCP in a very short period of time.

Fentanyl pectin nasal spray for painful mucositis in head and neck cancers during intensity-modulated radiation therapy with or without chemotherapy.

PURPOSE: The aim of the current analysis was to evaluate the effectiveness and tolerability of rapid onset opioid in a cohort of head and neck cancer (HNC) patients affected by painful mucositis influencing swallowing function during RT ± ChT with definitive or adjuvant intent. METHODS: A retrospective analysis was conduct on HNC patients during RT ± ChT that received fentanyl pectin na sal spray (FPNS) for incidental BTP due to painful mucositis 13 min before the main meals. The period of observation has been 90 days starting from the beginning of RT ± ChT. RESULTS: Forty HNC patients with incidental BTP due to painful mucositis treated with FPNS were analyzed. The mean NRS of untreated episodes of BTP was 5.73 ± 1.54 decreasing to 2.25 ± 2.45 with FPNS (median dose 100 mcg). During the pain treatment, the number of meals increased from 2.08 ± 0.35 to 2.868 ± 0.4 (p = 0.000), and the BMI remained stable (from 25.086 ± 3.292 to 25.034 ± 3.090; p = 0.448). The 94.9% of patients was satisfied or very satisfied for the rapidity of the effect, and 97.4% for the easiness and convenience in the use. CONCLUSIONS: FPNS showed an acceptable safety activity profile in predictable BTP due to painful mucositis in HNC patients during RT ± ChT. FPNS was also effective in reducing the mucositis sequelae and allowing the completion of RT scheduled scheme. Moreover, patients declared satisfaction in terms of ease of use.