NCT04267042|UnknownEarly Phase 1
Comparing Budesonide Via MAD or INSI Prospective Cohort Study
Prospective Double-Cohort Study: Comparing Efficacy of Budesonide Via MAD or INSI in Post-operative Treatment
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Prospective Double-Cohort Study: Comparing Efficacy of Budesonide Via MAD or INSI in Post-operative Treatment
Sponsor study identifier
interventional
60
0 countries
N/A
Study Start
February 3, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 3, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 3, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Chronic Rhinosinusitis (CRS) is a common disorder in North America, affecting more than 31 million people annually. Common therapy for CRS includes intranasal corticosteroids (INCS) such as budesonide. At our centre , the current practice is to administer budesonide two ways: the mucosal atomization device (MAD), which is a nasal spray or impregnated budesonide in nasal saline irrigation (INSI), which is a nasal rinse. Our study aims to see which method of administering budesonide has the best treatment outcomes after sinus surgery. This study will follow patients over a six-month period of time.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 3, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 28, 2020
Actual (reported)February 3, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 12, 2020
Actual (reported)February 3, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 3, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
SNOT-22 questionnaire
This is a standard of care form that includes 22 questions about symptoms and social/emotional consequences of your nasal disorder. You will be asked to rate your problems as they have been over the past two weeks. Patients will give a score out of 110 with a higher score relating to worse symptoms.
6 months postoperatively
MLK endoscopic scores
This score is based on the endoscopic assessment of polyps, edema, and discharge and are each given score 0-2. A score of 2 indicates a worse outcome.
6 months postoperatively
EQ 5D-5L questionnaireand
6 months postoperatively
Sniffin' Sticks Smell tests
6 months postoperatively
Sinus cultures
6 months postoperatively
IgE count
6 months postoperatively
Eosinophil count
6 months postoperatively
Patients in this arm will administer budesonide using a mucosal atomization device (MAD, Wolfe-Tory Medical, Salt Lake City, UT) once a day at least 5 times a week for 6 months postoperatively. The MAD atomizes the medication into particles from 30-100 um in size thus increasing the surface area for drug absorption. Budesonide is provided in nebules (1mg/2cc). Patients will place two nebules of budesonide into the MAD syringe.
Patients in this arm will administer impregnated budesonide in nasal saline irrigation (INSI) using a NeilMed squeeze bottle (NeilMed Pharmaceuticals, Santa Rosa, California) once a day at least 5 times a week for 6 months postoperatively. Budesonide is provided in nebules (1mg/2cc).Patients will place two nebules of budesonide into the 240mls of saline.
Budesonide is a corticosteroid that is commonly used intranasally to treat CRS.
MAD is a device used as an addition to a syringe to atomize medication to increase area of distribution. It is used to administer budesonide within the nasal passages and sinuses to administer medication for CRS.
Amin Javer, MD
The University of British Columbia and St. Paul's Sinus Centre
First Submitted
January 28, 2020
First Posted
February 12, 2020
Study Start
February 3, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 3, 2021
Betadine Rinses for Chronic Rhinosinusitis Prospective Cohort Study
INSI is delivered using a NeilMed squeeze bottle. It is used to administer budesonide within the nasal passages and sinuses to administer medication for CRS.
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Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 3, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 12, 2020
Record last verified: 2020-02
We will publish final outcomes as scientific paper.
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Source: ClinicalTrials.gov.
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