Polyp SinusNCT03848156
Characterisation of Nasal Polyps in Patients With and Without Aspirin-exacerbated Respiratory Disease
An observational study of Polyp Sinus, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Prevalence of aspirin-exacerbated respiratory disease (AERD) is 16% amongst patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). The mechanisms underlying the observed dysregulation of pro and anti-inflammatory pathways in AERD are still not fully understood. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyp Sinus
- What is being tested?
- biopsy
- How many people
- 23 participants
- Where
- 1 siteAustria
- Study dates
- 12 Feb 2019to 30 Nov 2019
- Phase
- Observational
- 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
Study population: Patients suffering from chronic rhinosinusitis with nasal polyps with/without AERD and with/without allergy
Who may be able to join
- Male or Female
- Age: 18-90
- Willingness to participate in the study
- Suffering from CRSwNP (with or without prior history of surgery for nasal polyposis)
- Allergic or non-allergic: if no recent allergy test is available (max. two years old) the presence or absence of allergy will be determined by skin prick test and by ImmunoCAP for allergen-specific serum immunoglobulin E (IgE) levels in addition to assessment of patients's history by questionnaire.
- Suffering from AERD or not as confirmed by provocation testing
Who cannot join
- Children
- Pregnant women - the presence of a known pregnancy will be assessed during the visit by questionnaire
- A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Depth Characterisation of Nasal Polyps in Patients With and Without Aspirin-exacerbated Respiratory Disease - a Pilot Study
Prevalence of aspirin-exacerbated respiratory disease (AERD) is 16% amongst patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). The mechanisms underlying the observed dysregulation of pro and anti-inflammatory pathways in AERD are still not fully understood. To address this and also to identify potential factors characterizing the disease the investigators plan to prospectively collect blood samples, nasal secretions as well as nasal biopsies from allergic, non-allergic and AERD patients suffering from CRSwNP. Initially, polyps of aforementioned patients will be subjected to RNA sequencing analysis using microarray technology. Once distinct factors are identified in nasal polyp tissue, their presence will be assessed in nasal secretions and serum of the respective patients to investigate their potential role as biomarkers. Furthermore presence of these parameters will be confirmed in situ in biopsies by confocal microscopy. Knowledge about factors differently upregulated in polyp tissue from AERD may contribute to a better understanding of the underlying mechanism of the 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 or aspirin-exacerbated respiratory disease (AERD). AERD 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 AERD patients.This indicates a dysregulation of pro and anti-inflammatory pathways. However the mechanism and the cells involved in causing this imbalance are still not clear.
The availability of gene-chip microarray technology allows for quantitatively and simultaneously monitoring of the expression of thousands of genes and has greatly contributed to the understanding of pathological mechanisms. In this context, analysis of nasal polyps from allergic patients has shown that genes involved in deregulated cell growth similar to neoplastic growth are upregulated in this tissue. Furthermore very recently, profiling of CRS samples by single-cell RNA sequencing revealed a significant loss of epithelial ecological diversity in nasal polyps. The authors suggest that basal cells form memories of chronic exposure to an inflammatory environment and shift the cellular ecosystem towards propagating the disease. However polyps from AERD patients which show a different clinical and most likely also pathophysiological profile have not been included in this study. Given the prevalence of 15% amongst CRSwNP patients and the impaired quality of life of AERD patients it would be desirable to understand the difference between AERD and CRSwNP without AERD at a molecular level and also to potentially find biomarkers that uniquely identify patients suffering from AERD disease.
Therefore, the investigators plan to prospectively collect blood samples, nasal secretions as well as nasal biopsies from allergic, non-allergic and AERD patients suffering from CRSwNP. Initially, RNA sequencing will be performed using microarray technology in biopsies of those patients. Once parameters are identified, the investigators will investigate if a similar pattern can also be detected in nasal secretions and/or serum of the respective patients to investigate their potential as biomarkers. Furthermore presence of these parameters will be confirmed in situ in biopsies by confocal microscopy.
- Conditions
- Polyp Sinus
- Being tested
- biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyOther
Biopsy of nasal polyp for RNA sequencing
| Study group | Role | What they receive |
|---|---|---|
| CRSwNP AERD allergic | Patients suffering from chronic rhinosinusitis with nasal polyps, allergy and aspirin exacerbated respiratory disease - biopsy for RNA sequencing Receives: Other: biopsy | |
| CRSwNP AERD non-allergic | Patients suffering from chronic rhinosinusitis with nasal polyps without allergy and aspirin exacerbated respiratory disease - biopsy for RNA sequencing Receives: Other: biopsy | |
| CRSwNP non-allergic | Patients suffering from chronic rhinosinusitis with nasal polyps without allergy - biopsy for RNA sequencing Receives: Other: biopsy | |
| CRSwNP allergic | Patients suffering from chronic rhinosinusitis with nasal polyps with allergy - biopsy for RNA sequencing Receives: Other: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNA Sequencing of polyps using Illumina platform
Differences in expression patterns in RNA expression in the 4 groups assessed using Illumina platform for RNA sequencing
Measured: patients will be recruited over the course of one year until 20 patients have been reached. Each patient will be sequenced when the sample is received.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start12 Feb 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyp SinusStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Sven Schneider, MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848156
- Sponsor's protocol ID
- AERD2019
- Status last verified
- Jan 2020
- First submitted
- 13 Feb 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Depth Characterisation of Nasal Polyps in Patients With and Without Aspirin-exacerbated Respiratory Disease - a Pilot Study
- ClinicalTrials.gov ID
- NCT03848156
- Acronym / sponsor ID
- AERD2019
- Conditions
- Polyp Sinus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 20 Feb 2019 (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.
Prevalence of aspirin-exacerbated respiratory disease (AERD) is 16% amongst patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). The mechanisms underlying the observed dysregulation of pro and anti-inflammatory pathways in AERD are still not fully understood. To address this and also to identify potential factors characterizing the disease the investigators plan to prospectively collect blood samples, nasal secretions as well as nasal biopsies from allergic, non-allergic and AERD patients suffering from CRSwNP. Initially, polyps of aforementioned patients will be subjected to RNA sequencing analysis using microarray technology. Once distinct factors are identified in nasal polyp tissue, their presence will be assessed in nasal secretions and serum of the respective patients to investigate their potential role as biomarkers. Furthermore presence of these parameters will be confirmed in situ in biopsies by confocal microscopy. Knowledge about factors differently upregulated in polyp tissue from AERD may contribute to a better understanding of the underlying mechanism of the 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 or aspirin-exacerbated respiratory disease (AERD). AERD 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 AERD patients.This indicates a dysregulation of pro and anti-inflammatory pathways. However the mechanism and the cells involved in causing this imbalance are still not clear.
The availability of gene-chip microarray technology allows for quantitatively and simultaneously monitoring of the expression of thousands of genes and has greatly contributed to the understanding of pathological mechanisms. In this context, analysis of nasal polyps from allergic patients has shown that genes involved in deregulated cell growth similar to neoplastic growth are upregulated in this tissue. Furthermore very recently, profiling of CRS samples by single-cell RNA sequencing revealed a significant loss of epithelial ecological diversity in nasal polyps. The authors suggest that basal cells form memories of chronic exposure to an inflammatory environment and shift the cellular ecosystem towards propagating the disease. However polyps from AERD patients which show a different clinical and most likely also pathophysiological profile have not been included in this study. Given the prevalence of 15% amongst CRSwNP patients and the impaired quality of life of AERD patients it would be desirable to understand the difference between AERD and CRSwNP without AERD at a molecular level and also to potentially find biomarkers that uniquely identify patients suffering from AERD disease.
Therefore, the investigators plan to prospectively collect blood samples, nasal secretions as well as nasal biopsies from allergic, non-allergic and AERD patients suffering from CRSwNP. Initially, RNA sequencing will be performed using microarray technology in biopsies of those patients. Once parameters are identified, the investigators will investigate if a similar pattern can also be detected in nasal secretions and/or serum of the respective patients to investigate their potential as biomarkers. Furthermore presence of these parameters will be confirmed in situ in biopsies by confocal microscopy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CRSwNP AERD allergic | – | Other: biopsyPatients suffering from chronic rhinosinusitis with nasal polyps, allergy and aspirin exacerbated respiratory disease - biopsy for RNA sequencing |
| CRSwNP AERD non-allergic | – | Other: biopsyPatients suffering from chronic rhinosinusitis with nasal polyps without allergy and aspirin exacerbated respiratory disease - biopsy for RNA sequencing |
| CRSwNP non-allergic | – | Other: biopsyPatients suffering from chronic rhinosinusitis with nasal polyps without allergy - biopsy for RNA sequencing |
| CRSwNP allergic | – | Other: biopsyPatients suffering from chronic rhinosinusitis with nasal polyps with allergy - biopsy for RNA sequencing |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from chronic rhinosinusitis with nasal polyps with/without AERD and with/without allergy
Key inclusion criteria (6 listed)
- Male or Female
- Age: 18-90
- Willingness to participate in the study
- Suffering from CRSwNP (with or without prior history of surgery for nasal polyposis)
- Allergic or non-allergic: if no recent allergy test is available (max. two years old) the presence or absence of allergy will be determined by skin prick test and by ImmunoCAP for allergen-specific serum immunoglobulin E (IgE) levels in addition to assessment of patients's history by questionnaire.
Key exclusion criteria (3 listed)
- Children
- Pregnant women - the presence of a known pregnancy will be assessed during the visit by questionnaire
- A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
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 |
|---|---|---|
| biopsyBiopsy of nasal polyp for RNA sequencing | Other | CRSwNP AERD allergic, CRSwNP AERD non-allergic, CRSwNP allergic, CRSwNP non-allergic |
Primary outcome
RNA Sequencing of polyps using Illumina platform
Time frame: patients will be recruited over the course of one year until 20 patients have been reached. Each patient will be sequenced when the sample is received.
Differences in expression patterns in RNA expression in the 4 groups assessed using Illumina platform for RNA 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 27 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Polyp Sinus, 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 6 inclusion and 3 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 27 Jan 2020. 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. 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?
RNA Sequencing of polyps using Illumina platform (time frame: patients will be recruited over the course of one year until 20 patients have been reached. Each patient will be sequenced when the sample is received.). 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 27 Jan 2020.