Chronic Rhinosinusitis With Nasal PolypsNASUMABNCT05938972
Real Life Study of Biologicals in Patients With Severe CRSwNP
An observational study of Chronic Rhinosinusitis With Nasal Polyps, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study is a pragmatic, real-life, observational study recruiting adult patients with chronic rhinosinusitis with nasal polyposis who are eligible to start biologicals as standard treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Mepolizumab
- How many people
- 180 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2022to 31 Dec 2030
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (between 18 and 80 years old) with severe allergic and/or eosinophilic asthma in group 1 and CRSwNP in group 2 that are receiving or will start to receive a biological as standard of care treatment, and agree on participating (signature of a written informed consent).
Who may be able to join
- Patients must meet the following criteria to be eligible for the enrolment in the study:
- Signed informed consent form (ICF),
- Age between 18 and 80 years at time of signing ICF,
- Able to comply with the study protocol, in the investigator's judgment,
- In group one: patients with severe allergic and/or eosinophilic asthma, defined by being currently treated with a biological (SoC) OR starting treatment with a biological (SoC).
- In group two: patients with CRSwNP with or without asthma, defined by starting treatment with a biological (SoC) and fulfill the criteria for reimbursement of a biological therapy
Who cannot join
- Patients who do not meet the reimbursement criteria of a biological therapy cannot participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Philippe Gevaert, Prof. Dr. contact
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Manon Blauwblomme, Masters, +32 09 332 23 95, manon.blauwblomme@ugent.be
Philippe Gevaert, Prof. Dr.
About this study
Official title: Real Life Study Assessing Long Term Outcomes and Predictive Factors of Response to Biologicals in Patients With Severe CRSwNP and/or Severe Allergic and/or Eosinophilic Asthma
This study is a pragmatic, real-life, observational study recruiting adult patients with chronic rhinosinusitis with nasal polyposis who are eligible to start biologicals as standard treatment. The aim of this study is to observe the long-term outcomes of biologicals in CRSwNP patients with or without comorbid asthma in 'real life'. Moreover, the investigators will gain insight into the mechanisms of biologicals in the local and systemic immunity of these patients and investigate novel local and systemic biomarkers and predictors of response.
Read the detailed description
In this project, thanks to intense collaboration between the ENT department and the pulmonary diseases within the Allergy Network UZ Gent, the investigators set up a prospective study and biobank with the following aims:
- To observe and follow-up on clinical characteristics in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) with or without asthma. Primary outcomes will be the endoscopic total nasal polyp score (NPS) and the nasal symptom scores (SNOT-22, VAS, NCS and UPSIT).
- Identifying key nasal inflammatory biomarkers to predict therapeutic response to biologicals in CRSwNP patients (identification on blood samples, nasal secretions, small tissue biopsies and superficial scrapings before, during and at month 24 of treatment).
- Unravel the effects of biologicals in the local nasal immune regulation.
- Performing additional analyses to search for new biomarkers via complete proteomic analysis.
Using a unique combination of nasal sampling and state of the art biomarker discovery, the investigators believe this research will provide unprecedented insights which will aid the treatment of patients with biologicals.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Mepolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabBiological
Also called Omalizumab, Dupilumab
Monoclonal antibodies
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics
Endoscopic total nasal polyp score to quantify nasal polyps with endoscopy. The higher the score, the more polyps are present in the nose. A unilateral score from 0 (absence of polyps) to 4 is given. The total nasal polyp score is the sum of the scores for both nostrils, thus ranging from 0 to 8, and is based on the continuous extension of nasal polyps beyond clear landmarks such as the upper and lower borders of the middle and inferior turbinate. This implies that a score can only be attributed if the criteria of the lower scores are met. E.g. a unilateral score of 3 cannot be given without nasal polyps also meeting the criteria for a score of 2, and similarly, a score of 4 cannot be given without having a score of 3.
Measured: 24 months
Clinical characeristics
Nasal symptom scores: VAS symptom scores and SNOT-22 questionnaire will be recorded through a questionnaire. The need for surgery or rescue medication (e.g. Systemic corticosteroids, antibiotics,..) will be recorded each study visit.
- VAS symptom score: minimum of 0 to maximum of 100. Higher VAS-scores indicate worse symptoms.
- SNOT-22 score: a validated, self-administered questionnaire that is used to assess CRS patients. It consists of 22 items, rated from 0 ('no problem at all') to 5 ('worst possible symptom'). Possible SNOT-22 total scores range from 0 to 110, with higher SNOT-22 total scores indicating worse symptoms
Measured: 24 months
Local nasal immunity
Nasal secretions will be harvested at each visit. Merocels (IVALON 4000 Plus 3,5 x 0,9 x 1,2 cm surgical products Fabco, New London, CT) will be placed in each nostril for 5 minutes and will be stored at -20°C until analysis. Key inflammatory markers will be measured: ECP, IL-5, sIL-5Rα, total IgE, periostin, total lambda- and kappa-FLC concentrations, MMP-9 and MPO. Additional analyses will then be performed to search for new biomarkers via complete proteomic analysis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Mar 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Gevaert, Prof. Dr., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938972
- Sponsor's protocol ID
- ONZ-2022-0033
- Acronym
- NASUMAB
- Status last verified
- Apr 2024
- First submitted
- 13 Jun 2023
- Last updated
- 15 Apr 2024
- 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 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Life Study Assessing Long Term Outcomes and Predictive Factors of Response to Biologicals in Patients With Severe CRSwNP and/or Severe Allergic and/or Eosinophilic Asthma
- ClinicalTrials.gov ID
- NCT05938972
- Acronym / sponsor ID
- NASUMAB / ONZ-2022-0033
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 11 Jul 2023 (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.
This study is a pragmatic, real-life, observational study recruiting adult patients with chronic rhinosinusitis with nasal polyposis who are eligible to start biologicals as standard treatment. The aim of this study is to observe the long-term outcomes of biologicals in CRSwNP patients with or without comorbid asthma in 'real life'. Moreover, the investigators will gain insight into the mechanisms of biologicals in the local and systemic immunity of these patients and investigate novel local and systemic biomarkers and predictors of response.
Detailed description
In this project, thanks to intense collaboration between the ENT department and the pulmonary diseases within the Allergy Network UZ Gent, the investigators set up a prospective study and biobank with the following aims:
- To observe and follow-up on clinical characteristics in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) with or without asthma. Primary outcomes will be the endoscopic total nasal polyp score (NPS) and the nasal symptom scores (SNOT-22, VAS, NCS and UPSIT).
- Identifying key nasal inflammatory biomarkers to predict therapeutic response to biologicals in CRSwNP patients (identification on blood samples, nasal secretions, small tissue biopsies and superficial scrapings before, during and at month 24 of treatment).
- Unravel the effects of biologicals in the local nasal immune regulation.
- Performing additional analyses to search for new biomarkers via complete proteomic analysis.
Using a unique combination of nasal sampling and state of the art biomarker discovery, the investigators believe this research will provide unprecedented insights which will aid the treatment of patients with biologicals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (between 18 and 80 years old) with severe allergic and/or eosinophilic asthma in group 1 and CRSwNP in group 2 that are receiving or will start to receive a biological as standard of care treatment, and agree on participating (signature of a written informed consent).
Key inclusion criteria (6 listed)
- Signed informed consent form (ICF),
- Age between 18 and 80 years at time of signing ICF,
- Able to comply with the study protocol, in the investigator's judgment,
- In group one: patients with severe allergic and/or eosinophilic asthma, defined by being currently treated with a biological (SoC) OR starting treatment with a biological (SoC).
- In group two: patients with CRSwNP with or without asthma, defined by starting treatment with a biological (SoC) and fulfill the criteria for reimbursement of a biological therapy
Key exclusion criteria (1 listed)
- Patients who do not meet the reimbursement criteria of a biological therapy cannot participate in 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 |
|---|---|---|
| MepolizumabAlso: Omalizumab, DupilumabMonoclonal antibodies | Biological | – |
Primary outcome
Clinical characteristics
Time frame: 24 months
Endoscopic total nasal polyp score to quantify nasal polyps with endoscopy. The higher the score, the more polyps are present in the nose. A unilateral score from 0 (absence of polyps) to 4 is given. The total nasal polyp score is the sum of the scores for both nostrils, thus ranging from 0 to 8, and is based on the continuous extension of nasal polyps beyond clear landmarks such as the upper and lower borders of the middle and inferior turbinate. This implies that a score can only be attributed if the criteria of the lower scores are met. E.g. a unilateral score of 3 cannot be given without nasal polyps also meeting the criteria for a score of 2, and similarly, a score of 4 cannot be given without having a score of 3.
Clinical characeristics
Time frame: 24 months
Nasal symptom scores: VAS symptom scores and SNOT-22 questionnaire will be recorded through a questionnaire. The need for surgery or rescue medication (e.g. Systemic corticosteroids, antibiotics,..) will be recorded each study visit. 1. VAS symptom score: minimum of 0 to maximum of 100. Higher VAS-scores indicate worse symptoms. 2. SNOT-22 score: a validated, self-administered questionnaire that is used to assess CRS patients. It consists of 22 items, rated from 0 ('no problem at all') to 5 ('worst possible symptom'). Possible SNOT-22 total scores range from 0 to 110, with higher SNOT-22 total scores indicating worse symptoms
Local nasal immunity
Time frame: 24 months
Nasal secretions will be harvested at each visit. Merocels (IVALON 4000 Plus 3,5 x 0,9 x 1,2 cm surgical products Fabco, New London, CT) will be placed in each nostril for 5 minutes and will be stored at -20°C until analysis. Key inflammatory markers will be measured: ECP, IL-5, sIL-5Rα, total IgE, periostin, total lambda- and kappa-FLC concentrations, MMP-9 and MPO. Additional analyses will then be performed to search for new biomarkers via complete proteomic analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- 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.
Philippe Gevaert, Prof. Dr. contact
Philippe Gevaert, Prof. Dr. principal investigator
University Hospital, Ghent
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 Chronic Rhinosinusitis With Nasal Polyps, run by University Hospital, Ghent at 1 site in Belgium.
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 1 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: looking for participants now, as of the sponsor's last update on 15 Apr 2024. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon Blauwblomme, Masters (+32 09 332 23 98, manon.blauwblomme@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical characteristics (time frame: 24 months). The study lists 3 primary outcomes in all. 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 15 Apr 2024.