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
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Feb 2020
Shorter than P25 for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2020
CompletedStudy Start
First participant enrolled
February 3, 2020
CompletedFirst Posted
Study publicly available on registry
February 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2021
CompletedFebruary 12, 2020
February 1, 2020
1 year
January 28, 2020
February 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (5)
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
Study Arms (2)
Budesonide via Mucosal Atomization Device (MAD)
ACTIVE COMPARATORPatients 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.
Budesonide via nasal saline irrigation (INSI)
ACTIVE COMPARATORPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients aged between 19 years and above
- Patients with chronic or recurrent sinusitis (as defined by the American Academy of Otolaryngology) with nasal polyposis or allergic fungal rhinosinusitis
- Patients with an upcoming primary sinus surgery or a revision sinus surgery
- Patients being prescribed INCS for the first time following Functional Endoscopic Sinus Surgery (FESS)
You may not qualify if:
- Individuals unable to understand the purpose, methods and conduct of this study
- Patients unwilling to provide informed consent
- Are immuno-compromised, and have impairment in mucociliary function (e.g., cystic fibrosis, Kartagener syndrome)
- Have autoimmune diseases affecting the upper airway (eg Systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis etc)
- Have sinonasal tumors
- Patients with a history of pituitary disease
- Patients with a known hypersensitivity to cortisol, corticotropin, or cosyntropin
- Recent use of systemic corticosteroids such as prednisone (within last 3 months)
- Patients that are not adherent to budesonide via MAD/INSI treatment
- Patients who are pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amin Javer, MD
The University of British Columbia and St. Paul's Sinus Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
January 28, 2020
First Posted
February 12, 2020
Study Start
February 3, 2020
Primary Completion
February 3, 2021
Study Completion
February 3, 2021
Last Updated
February 12, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share
We will publish final outcomes as scientific paper.