Comparing Budesonide Via MAD or INSI Prospective Cohort Study (NCT04267042) | Clinical Trial Compass
UnknownEarly Phase 1
Comparing Budesonide Via MAD or INSI Prospective Cohort Study
60 participantsStarted 2020-02-03
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.