Chronic Rhinosinusitis
Conditions
Keywords
Otolaryngology, Pharmacology, Pharmacy, intranasal steroid sprays
Brief summary
The goal of the proposed project is to assess the efficacy, safety, and patient experience of budesonide administered via the NasoNeb system for medical management of CRS. The authors propose a randomized controlled trial of nebulized budesonide via the NasoNeb compared against budesonide lavage.
Detailed description
Chronic rhinosinusitis is primarily an inflammatory disorder affecting up to 1 in 8 individuals and causing economic burden of greater than 13 billion USD. The NasoNeb is FDA approved for the nasal administration of medications; however, it has been scarcely studied in the existing literature. Many patients are intolerant of or non-compliant with other modalities of nasal steroid administration, and the NasoNeb represents a potential new treatment method for these patients. Participants will be provided with either a NasoNeb machine or NeilMed lavage bottle, and a prescription for a 42-day supply of 0.5 mg budesonide packets, to be used twice daily. For the NasoNeb, each dose will be dissolved in 10 mL saline with 5 mL nebulized solution being applied to each nasal cavity. This dose was chosen given the historical evidence of efficacy of budesonide 0.5mg daily application via saline lavage. For the lavage, each budesonide dose will be dissolved in 240 mL saline. Participants will be shown proper use of the NasoNeb machine or lavage bottle at the time of enrollment and be given written instructions with links to video tutorials.
Interventions
COMBINATION_PRODUCTnebulized budesonide via NasoNeb
For the nebulization group, each dose will be dissolved in 10 mL saline with 5 mL nebulized solution being applied to each nasal cavity. Device: NasoNeb
COMBINATION_PRODUCTbudesonide lavage via NeilMed
For the lavage group, each dose will be dissolved in 240 mL saline and 120 mL of the solution will be administered to each nasal cavity. Device: NeilMed
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Study coordinators will be blinded to treatment arm during data analysis.
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older that meet diagnostic criteria for CRS with or without polyposis as documented by their recruiting physician. * Diagnostic criteria for CRS will be defined according to EPOS criteria of \>12 weeks of 2 of the following subjective symptoms: nasal blockage or obstruction, rhinorrhea, hyposmia, or facial pain/pressure AND objective evidence of CRS on either nasal endoscopy or CT scan
Exclusion criteria
* Patients who have previously undergone sinus surgery * Severe polyposis; defined as Lund Kennedy endoscopy score greater than 1 * Patients who are currently using or who have previously used biologic medications for their nasal polyps. These medications include: dupilumab, omalizumab, mepolizumab, tezepelumab, or depemokimab * Inability to complete surveys in English * known comorbid mucociliary disease * known adrenal disease or other HPA dysfunction * patients taking oral corticosteroids for other medical conditions * oral antibiotic administration within 2 weeks of study participation * a baseline SNOT-22 score less than 9, due to inability to achieve the MCID
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sino-Nasal Outcome Test (SNOT-22) | week 6 | SNOT-22 is a 22-question survey designed to measure the physical, functional, and emotional consequences of rhinosinusitis. It contains questions regarding symptoms commonly associated with sinonasal disease. Subjects rate each question by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT-22 total score ranges from a minimum score of 0 to a maximum score of 110, with higher scores representing worse outcome. 9 point difference in SNOT-22 reduction is defined as the minimally clinically important improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lund-Kennedy scores | week 6 | Lund-Kennedy scores from nasal endoscopy will be recoded. The original LK system evaluates five components, each graded 0 to 2 for each side of nasal cavity. The score from both sides are summed up and for a total score ranging from 0-20 (10 points per side). Higher scores indicate more severe disease. Modified scores will be used. |
| cosyntropin stimulation | week 6 | Patients from both arms may volunteer for cosyntropin stimulation testing. This will be done to monitor for potential adrenal suppression related to treatment. Cosyntropin testing yields a numerical value with units of mcg/dL. We will use a threshold of normal to be greater than or equal to 18 mcg/dL at the 60 minute test. |
| Clinical Global Impression - Improvement (CGI-I) | week 3 and week 6 | The primary outcome measure will be the rate of responders (as a percentage) to the intervention defined as the number of participants reporting 2 (Moderately Improved), or 3 (Much Improved) in the Clinical Global Impression of Improvement (CGI-I) assessed after 6 weeks of treatment divided by the total number of participants in each study group. CGI-I asks subjects to rate their overall response to treatment using a 7-point Likert scale ranging from -3 to 3 (Much Worse to Much Improved). Participants responding 2 (Moderately Improved), or 3 (Much Improved) to the the CGI-I question Compared to the start of the study, how would you rate your nasal breathing now, will be defined as responders to treatment. |
| Sino-Nasal Outcome Test (SNOT-22) | week 3 | SNOT-22 is a 22-question survey designed to measure the physical, functional, and emotional consequences of rhinosinusitis. It contains questions regarding symptoms commonly associated with sinonasal disease. Subjects rate each question by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT-22 total score ranges from a minimum score of 0 to a maximum score of 110, with higher scores representing worse outcome. 9 point difference in SNOT-22 reduction is defined as the minimally clinically important improvement. |
Countries
United States
Contacts
Primary ContactNyssa Farrell, MD
Backup ContactSara Kukuljan
Outcome results
None listed