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Comparing Budesonide Via MAD or INSI Prospective Cohort Study

NCT04267042 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-02-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Budesonide

Budesonide is a corticosteroid that is commonly used intranasally to treat CRS.

DEVICE

Mucosal Atomization Device

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.

DEVICE

NeilMed squeeze bottle for Impregnated Nasal Saline Irrigation

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.

Sponsors & Collaborators

  • St. Paul's Hospital, Canada

    lead OTHER

Principal Investigators

  • Amin Javer, MD · The University of British Columbia and St. Paul's Sinus Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2021-02-03
Completion
2021-02-03

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04267042 on ClinicalTrials.gov