Chronic Rhinosinusitis With Nasal PolypsNCT05649813
A Study in Male and Female Adult Participants With Chronic Rhinosinusitis With Nasal Polyps In the Greater Gulf Region
An observational study of Chronic Rhinosinusitis With Nasal Polyps, run by Sanofi at 1 site in Kuwait.
Trial summary
Primary Objective: To describe the clinical characteristics of participants with chronic rhinosinusitis with nasal polyps (CRSwNP) in terms of disease severity, Type 2 inflammation-related comorbidities (such as asthma and allergic rhinitis), other associated comorbidities, and treatments used in a real-world setting… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- How many people
- 148 participants
- Where
- 1 siteKuwait
- Study dates
- 20 Nov 2022to 14 Jun 2024
- How long will I take part?
- 12 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with CRSwNP
Who may be able to join
- Male or female participants.
- Participants diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP) for at least one year prior to study start.
- Participants diagnosed with CRSwNP according to criteria of American Academy of Otolaryngology-Head and Neck Surgery (i.e. the diagnosis is confirmed in medical records by clinical symptoms and objective evidence of nasal polyps by using anterior rhinoscopy and nasal endoscopy when available and/or computed tomography (CT) scan).
- Participants should be at least 18 years old.
- Participants must have signed an informed consent.
Who cannot join
- Participants with chronic rhinosinusitis without nasal polyps (CRSsNP)
- Pregnant/breastfeeding participants or participants planning for a pregnancy.
- Participants participating in other interventional clinical trials involving any investigational drug.
- Participants with granulomatous diseases such as vasculitis or sarcoidosis. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Registry on Chronic RhinoSinusitis With Nasal Polyps In the Greater Gulf Region
Primary Objective:
- To describe the clinical characteristics of participants with chronic rhinosinusitis with nasal polyps (CRSwNP) in terms of disease severity, Type 2 inflammation-related comorbidities (such as asthma and allergic rhinitis), other associated comorbidities, and treatments used in a real-world setting
Secondary Objectives:
- Describe the progression in treatment outcomes at different visits (baseline, 3 months, 6 months, and 12 months).
- To assess the healthcare resource utilization of participants with CRSwNP in countries of the Gulf region (number of visits, emergency room (ER), surgery, etc).
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRSwNP | Participants with CRSwNP in the Gulf region |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with mild, moderate or severe disease (measured by visual analogue scale [VAS] score)
Measured: Day 0 (baseline) to Month 12
The mean baseline Sinonasal Outcome Test (SNOT-22) scores
Measured: Day 0
The mean baseline nasal polyps score (NPS)
Measured: Day 0
Percentage of participants with Type 2 inflammation-related comorbidities including bronchial asthma, allergic rhinitis, atopic dermatitis, chronic spontaneous urticaria, eosinophilic esophagitis (EoE), and food allergy
Measured: Day 0
Percentage of participants with other associated comorbidities including chronic obstructive pulmonary disease (COPD), ulcerative colitis, eosinophilic gastritis, or other comorbidities (if relevant)
Measured: Day 0
Percentage of different medications used by participants with CRSwNP during the follow-up period as per decision of the treating physician
Measured: Day 0 to Month 12
Secondary outcomes (10)
The mean change in the baseline Sinonasal Outcome Test (SNOT-22) scores
Measured: Day 0 (baseline), Month 3, Month 6, and Month 12
The mean change in the baseline nasal polyps score (NPS)
Measured: Day 0, Month 3, Month 6, and Month 12
Mean change in the baseline total symptoms score (TSS)
Measured: Day 0, Month 6, and Month 12
The proportion of CRSwNP patients with hospitalization
Measured: Day 0 to Month 12
The proportion of CRSwNP patients with emergency room (ER), office, or general practitioner visits
Measured: Day 0 to Month 12
The mean number of days/visits to ER, office, or general practitioner
Measured: Day 0 to Month 12
The mean number of days of sick leaves
Measured: Day 0 to Month 12
The proportion of surgical procedures performed during the hospital visit including nasal polypectomy with additional sinus dissection, isolated nasal polypectomy, or functional endoscopic sinus surgery [FESS])
Measured: Day 0 to Month 12
The mean number of participants with CRSwNP who need surgical treatment
Measured: Day 0 to Month 12
Total number of surgeries
Measured: Day 0 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start20 Nov 2022
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
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 SanofiThe 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
- 148 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649813
- Sponsor's protocol ID
- OBS17627
- Other IDs
- U1111-1279-3286
- Status last verified
- Jul 2024
- First submitted
- 15 Nov 2022
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry on Chronic RhinoSinusitis With Nasal Polyps In the Greater Gulf Region
- ClinicalTrials.gov ID
- NCT05649813
- Acronym / sponsor ID
- OBS17627
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 14 Dec 2022 (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.
Primary Objective:
- To describe the clinical characteristics of participants with chronic rhinosinusitis with nasal polyps (CRSwNP) in terms of disease severity, Type 2 inflammation-related comorbidities (such as asthma and allergic rhinitis), other associated comorbidities, and treatments used in a real-world setting
Secondary Objectives:
- Describe the progression in treatment outcomes at different visits (baseline, 3 months, 6 months, and 12 months).
- To assess the healthcare resource utilization of participants with CRSwNP in countries of the Gulf region (number of visits, emergency room (ER), surgery, etc).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRSwNP | – | –Participants with CRSwNP in the Gulf region |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with CRSwNP
Key inclusion criteria (5 listed)
- Male or female participants.
- Participants diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP) for at least one year prior to study start.
- Participants diagnosed with CRSwNP according to criteria of American Academy of Otolaryngology-Head and Neck Surgery (i.e. the diagnosis is confirmed in medical records by clinical symptoms and objective evidence of nasal polyps by using anterior rhinoscopy and nasal endoscopy when available and/or computed tomography (CT) scan).
- Participants should be at least 18 years old.
- Participants must have signed an informed consent.
Key exclusion criteria (4 listed)
- Participants with chronic rhinosinusitis without nasal polyps (CRSsNP)
- Pregnant/breastfeeding participants or participants planning for a pregnancy.
- Participants participating in other interventional clinical trials involving any investigational drug.
- Participants with granulomatous diseases such as vasculitis or sarcoidosis. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants with mild, moderate or severe disease (measured by visual analogue scale [VAS] score)
Time frame: Day 0 (baseline) to Month 12
The mean baseline Sinonasal Outcome Test (SNOT-22) scores
Time frame: Day 0
The mean baseline nasal polyps score (NPS)
Time frame: Day 0
Percentage of participants with Type 2 inflammation-related comorbidities including bronchial asthma, allergic rhinitis, atopic dermatitis, chronic spontaneous urticaria, eosinophilic esophagitis (EoE), and food allergy
Time frame: Day 0
Percentage of participants with other associated comorbidities including chronic obstructive pulmonary disease (COPD), ulcerative colitis, eosinophilic gastritis, or other comorbidities (if relevant)
Time frame: Day 0
Percentage of different medications used by participants with CRSwNP during the follow-up period as per decision of the treating physician
Time frame: Day 0 to Month 12
10 secondary outcomes
The mean change in the baseline Sinonasal Outcome Test (SNOT-22) scores
Time frame: Day 0 (baseline), Month 3, Month 6, and Month 12
The mean change in the baseline nasal polyps score (NPS)
Time frame: Day 0, Month 3, Month 6, and Month 12
Mean change in the baseline total symptoms score (TSS)
Time frame: Day 0, Month 6, and Month 12
The proportion of CRSwNP patients with hospitalization
Time frame: Day 0 to Month 12
The proportion of CRSwNP patients with emergency room (ER), office, or general practitioner visits
Time frame: Day 0 to Month 12
The mean number of days/visits to ER, office, or general practitioner
Time frame: Day 0 to Month 12
The mean number of days of sick leaves
Time frame: Day 0 to Month 12
The proportion of surgical procedures performed during the hospital visit including nasal polypectomy with additional sinus dissection, isolated nasal polypectomy, or functional endoscopic sinus surgery [FESS])
Time frame: Day 0 to Month 12
The mean number of participants with CRSwNP who need surgical treatment
Time frame: Day 0 to Month 12
Total number of surgeries
Time frame: Day 0 to Month 12
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 11 Jul 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
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 Sanofi at 1 site in Kuwait.
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 5 inclusion and 4 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 11 Jul 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 Kuwait. 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?
Percentage of participants with mild, moderate or severe disease (measured by visual analogue scale [VAS] score) (time frame: Day 0 (baseline) to Month 12). The study lists 6 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 11 Jul 2024.