Characterisation of the Nasal Microbiome in Patients With N-ERD (NCT04375293) | Clinical Trial Compass
CompletedNot Applicable
Characterisation of the Nasal Microbiome in Patients With N-ERD
Austria80 participantsStarted 2020-01-07
Plain-language summary
Chronic rhinosinusitis (CRS) with (w) and without (s) nasal polyps (NP) in its different shapes is currently affecting up to 16% of the total population of the United States and around 11% of the population in Europe. It may also be associated with a hypersensitivity to non-steroidal anti-inflammatory (NSAID) drugs in a syndrome called NSAID-exacerbated respiratory disease (N-ERD) characterized by highly recurrent polyps and concomitant asthma. The pathophysiological mechanisms especially with regards to the potential role of the microbiome in driving N-ERD are so far not fully understood. Here, the investigators plan to analyse the nasal microbiome in these patients and to compare it to nasal samples from CRSwNP and CRSsNP patients as well as healthy controls (in total 80 subjects). This will provide insights into potential differences in the microbiome as compared to other CRS patients and the impact of the microbiome in driving this disease.
Who can participate
Age range
18 Years – 90 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:
* Male or Female
* Age: 18-90
* Willingness to participate in the study
* No use of nasal or systemic corticosteroids or immunosuppressants 2 weeks prior to their visit
* Patient groups:
* Control group: absence of any signs of acute or chronic rhinosinusitis
* CRS:
CRSsNP CRSwNP N-ERD: N-ERD as previously confirmed by clinical history or provocation testing
The presence of CRS will be confirmed by endoscopy (part of routine assessment at the ORL department, no study procedure) according to AAO-HNSF guidelines as follows :
• Twelve weeks or longer of two or more of the following signs and symptoms:
* mucopurulent drainage (anterior, posterior, or both)
* nasal obstruction (congestion)
* facial pain-pressure-fullness, or
* decreased sense of smell
AND inflammation is documented by one or more of the following findings:
* purulent (not clear) mucus or edema in the middle meatus or anterior ethmoid region
* polyps in nasal cavity or the middle meatus, and/or
* radiographic imaging showing inflammation of the paranasal sinuses
Exclusion Criteria:
* Children
* Pregnant women (pregnancy test will be performed in women with child bearing potential)
* A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
* Use of nasal or systemic corticosteroids or immunosuppressants 2 weeks prior to their visit
* Patients with cystic fibrosis or immunosuppression.
* Severe anatomic variations or devia…
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.