Aspirin Exacerbated Respiratory DiseaseMicroNERDNCT04375293
Characterisation of the Nasal Microbiome in Patients With N-ERD
A study testing Microbiome swabs in people with Aspirin Exacerbated Respiratory Disease and Chronic Rhinitis, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aspirin Exacerbated Respiratory Disease, Chronic Rhinitis
- What is being tested?
- Microbiome swabs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 7 Jan 2020to 25 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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 deviations that do not allow access to all areas in the nasal cavity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterisation of the Nasal Microbiome in Patients Suffering From Non-steroidal Anti-inflammatory Drugs-exacerbated Respiratory Disease (N-ERD) - a Pilot Study
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.
Read the detailed description
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 . However CRS may also be associated with hypersensitivity to aspirin and other non-selective cyclooxygenase inhibitors. This syndrome of combined CRSwNP, asthma and intolerance to inhibitors of the cyclooxygenase-1 enzyme was termed Samter's triad, aspirin-exacerbated respiratory disease (AERD) and recently NSAID-exacerbated respiratory disease (N-ERD). N-ERD is thought to affect around 16% of patients suffering from CRSwNP , around 7% of adult asthmatic patients and 0.3-2.5% of the general population. One characteristic feature of this disease is the presence of nasal polyps that frequently relapse after surgery rendering this disease difficult to manage. Despite its relatively high prevalence, the pathophysiologic mechanisms are yet not fully understood. In this respect, an overproduction of and overresponsiveness to cysteinyl leukotrienes accompanied by and underproduction of and underresponsiveness to prostaglandins was observed in N-ERD patients.This indicates a dysregulation of pro and anti-inflammatory pathways.
Our mucosal body surfaces are colonized by a large variety of microbes organized within complex community structures. Novel sequencing techniques (e.g. 16SrRNA sequencing) have facilitated in-depth analysis of the nasal microbiome in health and disease. Recent studies show amongst other an enrichment in Haemophilus and Streptococcus in the nose of CRS patients, whereas nasal microbiome of healthy patients is rich in Propionibacterium acnes . So far, differences in microbiome were observed in healthy versus CRS patients, but the impact of the microbial environment in N-ERD has not been assessed yet and is thus aim of the study.
The investigators will collect nasal microbiome and nasal secretions from patients suffering from N-ERD and will compare them to the microbiome of CRSwNP, CRSsNP and healthy controls (n=20 per group). Additionally, cytokines in nasal secretions, protein expression at mRNA levels in nasal mucosa, and serum of these patients and clinical parameters (e.g. total nasal polyp score, quality of life questionnaire, olfactory performance) will be determined.
- Being tested
- Microbiome swabs
- Keywords
- aerd, microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome swabsOther
Swabs for analysis of microbiome
| Study group | Role | What they receive |
|---|---|---|
| AERD | Experimental | Patients suffering from AERD Receives: Other: Microbiome swabs |
| Healthy | Sham comparator | Healthy Controls Receives: Other: Microbiome swabs |
| CRSwNP | Active comparator | Patients suffering from CRS with nasal polyps Receives: Other: Microbiome swabs |
| CRSsNP | Active comparator | Patients suffering from CRS without nasal polyps Receives: Other: Microbiome swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal microbiome
Differences in microbial community composition between patients with N-ERD, CRSsNP, CRSwNP and healthy controls will be determined by 16S rRNA gene amplicon sequencing
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start7 Jan 2020
- Primary completion25 Jul 2021
- Study completion25 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspirin Exacerbated Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven Schneider, MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375293
- Sponsor's protocol ID
- MicroNERD
- Acronym
- MicroNERD
- Status last verified
- Aug 2021
- First submitted
- 24 Jan 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of the Nasal Microbiome in Patients Suffering From Non-steroidal Anti-inflammatory Drugs-exacerbated Respiratory Disease (N-ERD) - a Pilot Study
- ClinicalTrials.gov ID
- NCT04375293
- Acronym / sponsor ID
- MicroNERD / MicroNERD
- Keywords
- aerd, microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 25 Jul 2021 (actual)
- Study completion
- 25 Jul 2021 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 . However CRS may also be associated with hypersensitivity to aspirin and other non-selective cyclooxygenase inhibitors. This syndrome of combined CRSwNP, asthma and intolerance to inhibitors of the cyclooxygenase-1 enzyme was termed Samter's triad, aspirin-exacerbated respiratory disease (AERD) and recently NSAID-exacerbated respiratory disease (N-ERD). N-ERD is thought to affect around 16% of patients suffering from CRSwNP , around 7% of adult asthmatic patients and 0.3-2.5% of the general population. One characteristic feature of this disease is the presence of nasal polyps that frequently relapse after surgery rendering this disease difficult to manage. Despite its relatively high prevalence, the pathophysiologic mechanisms are yet not fully understood. In this respect, an overproduction of and overresponsiveness to cysteinyl leukotrienes accompanied by and underproduction of and underresponsiveness to prostaglandins was observed in N-ERD patients.This indicates a dysregulation of pro and anti-inflammatory pathways.
Our mucosal body surfaces are colonized by a large variety of microbes organized within complex community structures. Novel sequencing techniques (e.g. 16SrRNA sequencing) have facilitated in-depth analysis of the nasal microbiome in health and disease. Recent studies show amongst other an enrichment in Haemophilus and Streptococcus in the nose of CRS patients, whereas nasal microbiome of healthy patients is rich in Propionibacterium acnes . So far, differences in microbiome were observed in healthy versus CRS patients, but the impact of the microbial environment in N-ERD has not been assessed yet and is thus aim of the study.
The investigators will collect nasal microbiome and nasal secretions from patients suffering from N-ERD and will compare them to the microbiome of CRSwNP, CRSsNP and healthy controls (n=20 per group). Additionally, cytokines in nasal secretions, protein expression at mRNA levels in nasal mucosa, and serum of these patients and clinical parameters (e.g. total nasal polyp score, quality of life questionnaire, olfactory performance) will be determined.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AERD | Experimental | Other: Microbiome swabsPatients suffering from AERD |
| Healthy | Sham comparator | Other: Microbiome swabsHealthy Controls |
| CRSwNP | Active comparator | Other: Microbiome swabsPatients suffering from CRS with nasal polyps |
| CRSsNP | Active comparator | Other: Microbiome swabsPatients suffering from CRS without nasal polyps |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiome swabsSwabs for analysis of microbiome | Other | AERD, CRSsNP, CRSwNP, Healthy |
Primary outcome
Nasal microbiome
Time frame: 1 year
Differences in microbial community composition between patients with N-ERD, CRSsNP, CRSwNP and healthy controls will be determined by 16S rRNA gene amplicon sequencing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbiome swabs in people with Aspirin Exacerbated Respiratory Disease and Chronic Rhinitis, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal microbiome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.