Benralizumab effect on severe chronic rhinosinusitis with nasal polyps (CRSwNP): A randomized double‐blind placebo‐controlled trial

Author(s):  
Jody Tversky ◽  
Andrew P. Lane ◽  
Antoine Azar
2017 ◽  
Vol 140 (1) ◽  
pp. 271-273 ◽  
Author(s):  
Marcel M. Miyake ◽  
Angela Nocera ◽  
Patricia Levesque ◽  
Rong Guo ◽  
Christine A. Finn ◽  
...  

2019 ◽  
Vol 33 (5) ◽  
pp. 478-482 ◽  
Author(s):  
Kristin A. Seiberling ◽  
Stephanie C. Kidd ◽  
Grace H. Kim ◽  
Christopher A. Church

Background Topical nasal steroids are commonly prescribed to patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) following endoscopic sinus surgery (ESS). They are found to be effective in improving symptoms and quality of life as well as reducing the incidence of nasal polyps recurrence. Objective We sought to determine whether a higher concentration of topical nasal steroid spray is more effective than the standard nasal steroid spray in controlling symptoms and preventing recurrence of polyps in patients with CRSwNP who underwent ESS. Method A double-blind randomized controlled trial was performed on patients with CRSwNP after ESS. Patients were randomized into 2 treatment groups: one received topical nasal dexamethasone 0.032% and the other, fluticasone proprionate. The 22-item Sino-Nasal Outcome Test (SNOT-22) and Lund-Kennedy nasal endoscopy scores were measured at the initiation of topical nasal steroid treatment and then at approximately 4-, 8-, and 12-week intervals. Results Thirty-nine patients were enrolled in the study. Eighteen patients continued using the medications prescribed to them for the duration of the study. There were 8 patients in the dexamethasone group and 10 patients in the fluticasone group. Both groups saw significant improvements in postoperative SNOT-22 and Lund-Kenney scores over time. There was no significant difference in improvement between the groups. Conclusion There is no significant increased benefit in using a higher dose nasal steroid spray compared to the standard dose nasal steroid spray after ESS.


2010 ◽  
Vol 48 (3) ◽  
pp. 318-324 ◽  
Author(s):  
J.M. Pinto ◽  
N. Mehta ◽  
M. DiTineo ◽  
J. Wang ◽  
F.M. Baroody ◽  
...  

2021 ◽  
Vol 75 (4) ◽  
pp. 1-5
Author(s):  
Konstantin Dobretsov ◽  
Oxana Kolenchukova ◽  
Alexander Sipkin ◽  
Luisa Bellussi ◽  
Giorgio Ciprandi ◽  
...  

Background A randomized, double-blind placebo-controlled study investigated the use of bacteriophages in the treatment of chronic rhinosinusitis with nasal polyps. Materials and Methods 40 adult patients with сhronic rhinosinusitis with nasal polyps were examined. All patients underwent functional endoscopic sinus surgery. After the surgery, 20 patients got the intranasal gel with a bacteriophages mixture (Otofag, Micromir, Russia) twice a day for ten weeks, and 20 patients got a placebo. Results On the 10th day, IL-1β secretion diminished (63 mg/ml versus 440 mg/ml in control). There was a decrease in the total number of microorganisms and Enterobacteriaceae (5.7 x 106 CFU/ml versus 1.2 x 109 CFU/ml in control), and the absence of Streptococci (versus 2.1 x 109 CFU/ml in control) on the 30th day of the treatment in the group with the bacteriophages. On the 10th day, a decrease in the activity of secretory IL-1β and IL-8 strongly and very strongly correlated with a total number of microorganisms (r = 0.7; r = 0.9 respectively), as well as secretory IL-8 with Enterobacteriaceae (r = 0.72) and Staphylococci (r = 0.65) in the active group treated with the bacteriophages. On the 30th day, the decrease in serum IL-1β significantly correlated with the total number of microorganisms (r = 0.80) and enterobacteria (r = 0.90) in the active group. Conclusions The administration of bacteriophages restored the balance of microorganisms in the nasal cavity and decreased the inflammatory response in chronic rhinosinusitis with nasal polyps. These changes, such as an inflammation dampening, could theoretically reduce the recurrent growth of polyp tissue in the future.


2010 ◽  
Vol 48 (3) ◽  
pp. 318-324
Author(s):  
J.M. Pinto ◽  
N. Mehta ◽  
M. DiTineo ◽  
J. Wang ◽  
F.M. Baroody ◽  
...  

Evidence suggests IgE may play a role in chronic rhinosinusitis (CRS). We sought to determine if treatment with a monoclonal antibody against IgE (omalizumab) is effective in reducing CRS inflammation. We performed a randomized, double blind, placebo controlled clinical trial in subjects with CRS despite treatment (including surgery). Subjects were randomized to receive omalizumab or placebo for 6 months. The primary outcome was quantitative measurement of sinus inflammation on imaging. Secondary outcome measures included quality of life, symptoms, and cellular inflammation, nasal airflow (NPIF) and olfactory testing (UPSIT). Subjects on omalizumab showed reduced inflammation on imaging after treatment, whereas those on placebo showed no change. The net difference, however, was not different between treatments. Treatment with omalizumab was associated with improvement in the Sino-Nasal Outcome Test (SNOT-20) at 3, 5, and 6 months compared to baseline with no significant changes in the control group. Remaining measures showed no significant differences across treatments. We conclude that IgE plays, at most, a small role in the mucosal inflammation of CRS and the symptoms. Placebo controlled, blinded studies with larger enrollment are needed to determine the clinical significance of any potential change.


2006 ◽  
Vol 21 (1-2) ◽  
pp. 24-27
Author(s):  
Romeo C. Sanchez ◽  
Benjamin SA. Campomanes ◽  
Natividad A. Aguilar

Objectives: To determine the efficacy of a 7-day treatment of methylprednisolone 16mg in reducing the size of nasal polyps and on improvement of nasal symptoms.   Methods: Design: Randomized double-blind placebo-controlled trial Setting: Out-patient department of the East Avenue Medical Center Patients: Patients 18 years old and above with nasal polyposis determined by history and endoscopic examination   Results: There was a significant decrease in polyp size by an average of 16% (P < .05) among 12 out of the 23 patients (52.17 %) in the steroid group versus placebo. The treatment group also exhibited an improvement in nasal symptoms of rhinorrhea, congestion and anosmia compared to the placebo.   Conclusion: Medical treatment with oral methylprednisolone given at a low dose of 16 mg for one week resulted in reduction of the size of nasal polyps and improved the symptoms of rhinorrhea, nasal congestion and anosmia. Other associated symptoms like headache, epistaxis,  sneezing, itchiness, epiphora, cough, postnasal drip, throat discomfort, facial pain, eye complaints and fever did not differ between the steroid and placebo groups.   Recommendation: One week of oral steroids can be used to treat nasal polyps initially. If there is response, this mode of management can be combined with a long-term course of intranasal steroid sprays9,10. Patients who do not respond may be referred for surgery.   Keywords: Nasal polyposis, methylprednisolone, rhinorrhea, nasal congestion, anosmia  


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