About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

nebulized budesonide via NasoNeb
Combination product
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
budesonide lavage via NeilMed
Combination product
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

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: nebulizer groupExperimental treatment 1 intervention

Group B: budesonide lavage groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sino-Nasal Outcome Test (SNOT-22)

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.

Time frame

week 6

Secondary outcomes

1

Lund-Kennedy scores

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.

Time frame

week 6

2

cosyntropin stimulation

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.

Time frame

week 6

3

Clinical Global Impression - Improvement (CGI-I)

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.

Time frame

week 3 and week 6

4

Sino-Nasal Outcome Test (SNOT-22)

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.

Time frame

week 3

Nebulized Nasal Steroids

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts