Chronic Rhinosinusitis With Nasal PolypsDupi-PNSNCT06017427
Evaluation of Patient Satisfaction During Treatment With Dupilumab in Severe and Recurrent Nasosinusal Polyposis Despite Appropriate Medical and Surgical Treatment.
An observational study of Chronic Rhinosinusitis With Nasal Polyps, run by IHU Strasbourg at 1 site in France.
Trial summary
Chronic rhinosinusitis with nasal polyps (CRSwNP) or nasal polyposis is a frequent disease leading to a decreased quality of life. The validated course of treatment is firstly a medical one with saline irrigations and topical corticosteroids, followed by surgery (ethmoidectomy) if the medical treatment fails. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Questionnaires
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2023to 21 Sep 2023
- 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: Adult patients, men or women, of any age, having received treatment with Dupilumab for the indication of recurrent severe nasal polyposis despite surgery and appropriate medical treatment
Who may be able to join
- Women and men over 18 years old
- Suffering from severe and recurrent Chronic Rhinosinusitis with Nasal Polyps despite having benefited from the appropriate medical and surgical treatment.
- CRSwNP diagnosis established on the basis of clinical presentation and patient interrogation by their referent ENT surgeon.
- Patient treated with Dupilumab in the indication depicted in bullet point 2.
- Patient having voiced their non-opposition to this research, having received clear and appropriate information.
- Patient affiliated to the French Social Security.
Who cannot join
- Patient having undergone endoscopic nasal surgery during their Dupilumab treatment.
- Patient presenting exclusion criteria for Dupilumab treatment.
- Patient suffering from immune deficit.
- Patient suffering from vascularitis with nasal expression.
- Patient whose autonomy has been reduced by a legal authority.
- Patient unable to express their agreement to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic rhinosinusitis with nasal polyps (CRSwNP) or nasal polyposis is a frequent disease leading to a decreased quality of life. The validated course of treatment is firstly a medical one with saline irrigations and topical corticosteroids, followed by surgery (ethmoidectomy) if the medical treatment fails.
In many cases, CRSwNP becomes a recurrent disease despite maximal treatment as previously indicated and it becomes refractory, with a chronically reduced quality of life.
Read more
New treatments known as Biologics or Biotherapies in France such as Dupilumab are now available in situations of severe recurrent CRSwNP despite the appropriate treatment.
The goal of this study is to assess the clinical effectiveness of Dupilumab and patient satisfaction, in a cohort of french patients, focusing on the change in quality of life that is expected from said treatment, over a period of one year.
Patients will undergo 6 months of treatment with Dupilumab, the treatment will then be stopped for the next 6 months.
The primary judgment criteria will be the SNOT 22 score, measured before treatment, after 6 months of treatment, and 6 months after stopping treatment, over a telephonic conversation.
Read the detailed description
CRSwNP has existed for over 5000 years, it is a frequent disease, affecting 1 to 4 % of the general population, especially older men and is defined by inflammatory modification of the sinuses and nasal cavities with benign growths of the mucosa known as polyps. It leads to numerous symptoms (nasal blockage, anosmia, nasal dripping, fatigue, pain), which have important consequences in terms of quality of life, social interactions, and by the heavy costs that are brought by medical and surgical treatment.
It is a multifactorial disease for which physiopathology is not well established.
No definitive treatment exists. The appropriate course of treatment aims to control the disease, but not cure it, via topical corticosteroids application which can be facilitated by endoscopic surgery (polypectomy, ethmoidectomy).
Recurrence is frequent after surgery (40 %, 18 months after surgery), which leads to more surgeries that get more complicated and riskier each time.
CRSwNP is also an expensive disease (several thousands of euros per year for one patient), especially in cases of recurrence after surgical treatment. The indirect costs are also high with work absenteeism and decreased productivity making CRSwNP one of the 10 most costly diseases for US employers.
Dupilumab, a biologic treatment targeting the receptors of IL4 and IL13 which are major actors of the inflammatory reaction at hand in CRSwNP, has recently appeared on the market for treatment of severe recurrent CRSwNP despite the appropriate medical and surgical treatment, and has proved its efficacy in randomized clinical trials.
It is a very expensive treatment (1400 euros a month for one patient in France), which is why its clinical effectiveness in a real-life setting must be assessed.
Hypothesis : Dupilumab improves symptoms and quality of life in severe recurrent CRSwNP despite the appropriate medical and surgical treatment.
Objectives : To assess the effect of Dupilumab and patient satisfaction during treatment and after its discontinuation, on symptoms and quality of life in patients suffering from severe and recurrent CRSwNP despite having benefited from the appropriate medical and surgical treatment, in a French real-life cohort.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Questionnaires
- Keywords
- CRSwNP, decreased quality of life, Nasal polyps, Rhinosinusitis, recurrent CRSwNP, severe CRSwNP
- Medical subject headings
- Nasal Polyps, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Submission of several questionnaires (Quality of Life and clinical scores) at three time points: before initiation of Dupilumab, after 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering from severe recurrent CRSwNP and treated with Dupilumab | Patients suffering from severe recurrent CRSwNP despite having benefited from the appropriate medical and surgical treatment and treated with Dupilumab for 6 months Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the global effect of Dupilumab 1 day before Dupilumab by the mean of the SNOT 22 score
The SNOT22 score is a validated questionnaire for the assessment of symptoms of Chronic rhinosinusitis, ranging from 0 to 110. The more severe are the disease and its associated symptoms, the higher is the score
Measured: 1 day before Dupilumab
Assessment of the global effect of Dupilumab 6 months of Dupilumab treatment by the mean of the SNOT 22 score
The SNOT22 score is a validated questionnaire for the assessment of symptoms of Chronic rhinosinusitis, ranging from 0 to 110. The more severe are the disease and its associated symptoms, the higher is the score
Measured: 6 months of Dupilumab treatment
Assessment of the global effect of Dupilumab 6 months after stopping the treatment by the mean of the SNOT 22 score
The SNOT22 score is a validated questionnaire for the assessment of symptoms of Chronic rhinosinusitis, ranging from 0 to 110. The more severe are the disease and its associated symptoms, the higher is the score
Measured: 6 months after stopping Dupilumab treatment
Secondary outcomes (12)
Assessment of the effect of Dupilumab on nasal obstruction by the mean of the Visual Analogic Scale for nasal obstruction
Staging nasal obstruction level from 0 to 10. The more severe are the symptoms, the higher is the score
Measured: 1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment
Assessment of the effect of Dupilumab on the olfaction by the mean of the Visual Analogic Scale for Olfaction
Staging olfaction levels from 0 to 10. The more severe are the symptoms, the higher is the score
Measured: 1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment
Assessment of the effect of Dupilumab on the severity of the nasal polyposis by the mean of the Nasal Polyp Score
Endoscopic based score assessing the severity of nasal polyposis, 0 to 8. The more severe are the symptoms, the higher is the score
Measured: 1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment
Assessment of the effect of Dupilumab on the severity of the nasal polyposis on an iconographic level by the mean of the Lund McKay score
CT-scan based score assessing the severity of nasal polyposis on an iconographic level, 0 to 24. The more severe are the symptoms, the higher is the score
Measured: 1 day before the treatment initiation
Assessment of the effect of Dupilumab on the quality of life by the mean of the EQ 5D 5L score
Quality of life questionnaire associated with a Visual Analogic Scale ranging from 0 to 100. The more severe are the symptoms, the higher is the score
Measured: 1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment
Assessment of the effect of Dupilumab on the severity of the asthma by the mean of the ACT score
Asthma control assessment score ranging from 5 to 25. The more severe are the symptoms, the higher is the score
Measured: 1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment
Assessment of the time to first improvement in sense of smell and nasal obstruction with Dupilumab
Time between the beginning of treatment with Dupilumab and the first time a reduction in nasal obstruction and hyposmia was observed by the patient
Measured: 1 day
Time between stopping Dupilumab and possible deterioration of the sense of smell and nasal obstruction
Time between the stopping of Dupilumab treatment and the first worsening of nasal obstruction and olfaction that was noted by the patient
Measured: 1 day
Evolution of a potential middle ear chronic inflammation during treatment
rate of otitis appearance among the patients during their treatment with Dupilumab
Measured: 1 day
Necessity to use oral corticosteroids during or after Dupilumab treatment
Rate of patients in need of corticosteroids during or after their treatment with Dupilumab
Measured: 1 day
Evolution to nasosinus superinfections during and after Dupilumab treatment
Rate of nasosinus superinfections appearance observed during or after the treatment with Dupilumab
Measured: 1 day
Collect of adverse effects during Dupilumab treatment
collect of adverse effects during Dupilumab treatment
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start30 Aug 2023
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
Why it stopped: Number of inclusions sufficient for answering the main objective
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Léa FATH, MD, PhD, Principal investigator, HUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017427
- Sponsor's protocol ID
- 22-005
- Acronym
- Dupi-PNS
- Status last verified
- Jan 2024
- First submitted
- 18 Jul 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Settipane RA, Peters AT, Chiu AG. Chapter 6: Nasal polyps. Am J Rhinol Allergy. 2013 May-Jun;27 Suppl 1:S20-5. doi: 10.2500/ajra.2013.27.3926.
PubMed 23711034Stjarne P, Odeback P, Stallberg B, Lundberg J, Olsson P. High costs and burden of illness in acute rhinosinusitis: real-life treatment patterns and outcomes in Swedish primary care. Prim Care Respir J. 2012 Jun;21(2):174-9; quiz 10p following 179. doi: 10.4104/pcrj.2012.00011.
PubMed 22349918Teul I, Zbislawski W, Baran S, Czerwinski F, Lorkowski J. Quality of life of patients with diseases of sinuses. J Physiol Pharmacol. 2007 Nov;58 Suppl 5(Pt 2):691-7.
PubMed 18204184Hopkins C, Browne JP, Slack R, Lund V, Topham J, Reeves B, Copley L, Brown P, van der Meulen J. The national comparative audit of surgery for nasal polyposis and chronic rhinosinusitis. Clin Otolaryngol. 2006 Oct;31(5):390-8. doi: 10.1111/j.1749-4486.2006.01275.x.
PubMed 17014448Leopold DA, Elkayam D, Messina JC, Kosik-Gonzalez C, Djupesland PG, Mahmoud RA. NAVIGATE II: Randomized, double-blind trial of the exhalation delivery system with fluticasone for nasal polyposis. J Allergy Clin Immunol. 2019 Jan;143(1):126-134.e5. doi: 10.1016/j.jaci.2018.06.010. Epub 2018 Jun 19.
PubMed 29928924Kobayashi Y, Yasuba H, Asako M, Yamamoto T, Takano H, Tomoda K, Kanda A, Iwai H. HFA-BDP Metered-Dose Inhaler Exhaled Through the Nose Improves Eosinophilic Chronic Rhinosinusitis With Bronchial Asthma: A Blinded, Placebo-Controlled Study. Front Immunol. 2018 Sep 25;9:2192. doi: 10.3389/fimmu.2018.02192. eCollection 2018.
PubMed 30337921Rice DH. Endoscopic sinus surgery. Otolaryngol Head Neck Surg. 1994 Jul;111(1):100-10. doi: 10.1177/019459989411100118. No abstract available.
PubMed 8028915Benninger MS, Sindwani R, Holy CE, Hopkins C. Impact of medically recalcitrant chronic rhinosinusitis on incidence of asthma. Int Forum Allergy Rhinol. 2016 Feb;6(2):124-9. doi: 10.1002/alr.21652. Epub 2015 Dec 1.
PubMed 26624856DeConde AS, Mace JC, Levy JM, Rudmik L, Alt JA, Smith TL. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2017 Mar;127(3):550-555. doi: 10.1002/lary.26391. Epub 2016 Nov 12.
PubMed 27859303Bhattacharyya N. Contemporary assessment of the disease burden of sinusitis. Am J Rhinol Allergy. 2009 Jul-Aug;23(4):392-5. doi: 10.2500/ajra.2009.23.3355.
PubMed 19671253Wahid NW, Smith R, Clark A, Salam M, Philpott CM. The socioeconomic cost of chronic rhinosinusitis study. Rhinology. 2020 Apr 1;58(2):112-125. doi: 10.4193/Rhin19.424.
PubMed 32172284Lourijsen ES, Fokkens WJ, Reitsma S. Direct and indirect costs of adult patients with chronic rhinosinusitis with nasal polyps. Rhinology. 2020 Jun 1;58(3):213-217. doi: 10.4193/Rhin19.468.
PubMed 32415826Bhattacharyya N. Assessing the additional disease burden of polyps in chronic rhinosinusitis. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):185-9. doi: 10.1177/000348940911800305.
PubMed 19374149Goetzel RZ, Hawkins K, Ozminkowski RJ, Wang S. The health and productivity cost burden of the "top 10" physical and mental health conditions affecting six large U.S. employers in 1999. J Occup Environ Med. 2003 Jan;45(1):5-14. doi: 10.1097/00043764-200301000-00007.
PubMed 12553174Rudmik L. Economics of Chronic Rhinosinusitis. Curr Allergy Asthma Rep. 2017 Apr;17(4):20. doi: 10.1007/s11882-017-0690-5.
PubMed 28337570
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Satisfaction During Treatment With Dupilumab in Severe and Recurrent Nasosinusal Polyposis Despite Appropriate Medical and Surgical Treatment.
- ClinicalTrials.gov ID
- NCT06017427
- Acronym / sponsor ID
- Dupi-PNS / 22-005
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Keywords
- CRSwNP, decreased quality of life, Nasal polyps, Rhinosinusitis, recurrent CRSwNP, severe CRSwNP
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Number of inclusions sufficient for answering the main objective
- Enrolment
- 32 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 30 Aug 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.
Chronic rhinosinusitis with nasal polyps (CRSwNP) or nasal polyposis is a frequent disease leading to a decreased quality of life. The validated course of treatment is firstly a medical one with saline irrigations and topical corticosteroids, followed by surgery (ethmoidectomy) if the medical treatment fails.
In many cases, CRSwNP becomes a recurrent disease despite maximal treatment as previously indicated and it becomes refractory, with a chronically reduced quality of life.
New treatments known as Biologics or Biotherapies in France such as Dupilumab are now available in situations of severe recurrent CRSwNP despite the appropriate treatment.
The goal of this study is to assess the clinical effectiveness of Dupilumab and patient satisfaction, in a cohort of french patients, focusing on the change in quality of life that is expected from said treatment, over a period of one year.
Patients will undergo 6 months of treatment with Dupilumab, the treatment will then be stopped for the next 6 months.
The primary judgment criteria will be the SNOT 22 score, measured before treatment, after 6 months of treatment, and 6 months after stopping treatment, over a telephonic conversation.
Detailed description
CRSwNP has existed for over 5000 years, it is a frequent disease, affecting 1 to 4 % of the general population, especially older men and is defined by inflammatory modification of the sinuses and nasal cavities with benign growths of the mucosa known as polyps. It leads to numerous symptoms (nasal blockage, anosmia, nasal dripping, fatigue, pain), which have important consequences in terms of quality of life, social interactions, and by the heavy costs that are brought by medical and surgical treatment.
It is a multifactorial disease for which physiopathology is not well established.
No definitive treatment exists. The appropriate course of treatment aims to control the disease, but not cure it, via topical corticosteroids application which can be facilitated by endoscopic surgery (polypectomy, ethmoidectomy).
Recurrence is frequent after surgery (40 %, 18 months after surgery), which leads to more surgeries that get more complicated and riskier each time.
CRSwNP is also an expensive disease (several thousands of euros per year for one patient), especially in cases of recurrence after surgical treatment. The indirect costs are also high with work absenteeism and decreased productivity making CRSwNP one of the 10 most costly diseases for US employers.
Dupilumab, a biologic treatment targeting the receptors of IL4 and IL13 which are major actors of the inflammatory reaction at hand in CRSwNP, has recently appeared on the market for treatment of severe recurrent CRSwNP despite the appropriate medical and surgical treatment, and has proved its efficacy in randomized clinical trials.
It is a very expensive treatment (1400 euros a month for one patient in France), which is why its clinical effectiveness in a real-life setting must be assessed.
Hypothesis : Dupilumab improves symptoms and quality of life in severe recurrent CRSwNP despite the appropriate medical and surgical treatment.
Objectives : To assess the effect of Dupilumab and patient satisfaction during treatment and after its discontinuation, on symptoms and quality of life in patients suffering from severe and recurrent CRSwNP despite having benefited from the appropriate medical and surgical treatment, in a French real-life cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from severe recurrent CRSwNP and treated with Dupilumab | – | Other: QuestionnairesPatients suffering from severe recurrent CRSwNP despite having benefited from the appropriate medical and surgical treatment and treated with Dupilumab for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, men or women, of any age, having received treatment with Dupilumab for the indication of recurrent severe nasal polyposis despite surgery and appropriate medical treatment
Key inclusion criteria (6 listed)
- Women and men over 18 years old
- Suffering from severe and recurrent Chronic Rhinosinusitis with Nasal Polyps despite having benefited from the appropriate medical and surgical treatment.
- CRSwNP diagnosis established on the basis of clinical presentation and patient interrogation by their referent ENT surgeon.
- Patient treated with Dupilumab in the indication depicted in bullet point 2.
- Patient having voiced their non-opposition to this research, having received clear and appropriate information.
Key exclusion criteria (6 listed)
- Patient having undergone endoscopic nasal surgery during their Dupilumab treatment.
- Patient presenting exclusion criteria for Dupilumab treatment.
- Patient suffering from immune deficit.
- Patient suffering from vascularitis with nasal expression.
- Patient whose autonomy has been reduced by a legal authority.
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 |
|---|---|---|
| QuestionnairesSubmission of several questionnaires (Quality of Life and clinical scores) at three time points: before initiation of Dupilumab, after 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment | Other | Patients suffering from severe recurrent CRSwNP and treated with Dupilumab |
Primary outcome
Assessment of the global effect of Dupilumab 1 day before Dupilumab by the mean of the SNOT 22 score
Time frame: 1 day before Dupilumab
The SNOT22 score is a validated questionnaire for the assessment of symptoms of Chronic rhinosinusitis, ranging from 0 to 110. The more severe are the disease and its associated symptoms, the higher is the score
Assessment of the global effect of Dupilumab 6 months of Dupilumab treatment by the mean of the SNOT 22 score
Time frame: 6 months of Dupilumab treatment
The SNOT22 score is a validated questionnaire for the assessment of symptoms of Chronic rhinosinusitis, ranging from 0 to 110. The more severe are the disease and its associated symptoms, the higher is the score
Assessment of the global effect of Dupilumab 6 months after stopping the treatment by the mean of the SNOT 22 score
Time frame: 6 months after stopping Dupilumab treatment
The SNOT22 score is a validated questionnaire for the assessment of symptoms of Chronic rhinosinusitis, ranging from 0 to 110. The more severe are the disease and its associated symptoms, the higher is the score
12 secondary outcomes
Assessment of the effect of Dupilumab on nasal obstruction by the mean of the Visual Analogic Scale for nasal obstruction
Time frame: 1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment
Assessment of the effect of Dupilumab on the olfaction by the mean of the Visual Analogic Scale for Olfaction
Time frame: 1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment
Assessment of the effect of Dupilumab on the severity of the nasal polyposis by the mean of the Nasal Polyp Score
Time frame: 1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment
Assessment of the effect of Dupilumab on the severity of the nasal polyposis on an iconographic level by the mean of the Lund McKay score
Time frame: 1 day before the treatment initiation
Assessment of the effect of Dupilumab on the quality of life by the mean of the EQ 5D 5L score
Time frame: 1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment
Assessment of the effect of Dupilumab on the severity of the asthma by the mean of the ACT score
Time frame: 1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment
Assessment of the time to first improvement in sense of smell and nasal obstruction with Dupilumab
Time frame: 1 day
Time between stopping Dupilumab and possible deterioration of the sense of smell and nasal obstruction
Time frame: 1 day
Evolution of a potential middle ear chronic inflammation during treatment
Time frame: 1 day
Necessity to use oral corticosteroids during or after Dupilumab treatment
Time frame: 1 day
Evolution to nasosinus superinfections during and after Dupilumab treatment
Time frame: 1 day
Collect of adverse effects during Dupilumab treatment
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Number of inclusions sufficient for answering the main objective). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Background: PubMed 23711034Settipane RA, Peters AT, Chiu AG. Chapter 6: Nasal polyps. Am J Rhinol Allergy. 2013 May-Jun;27 Suppl 1:S20-5. doi: 10.2500/ajra.2013.27.3926.
- Background: PubMed 22349918Stjarne P, Odeback P, Stallberg B, Lundberg J, Olsson P. High costs and burden of illness in acute rhinosinusitis: real-life treatment patterns and outcomes in Swedish primary care. Prim Care Respir J. 2012 Jun;21(2):174-9; quiz 10p following 179. doi: 10.4104/pcrj.2012.00011.
- Background: PubMed 18204184Teul I, Zbislawski W, Baran S, Czerwinski F, Lorkowski J. Quality of life of patients with diseases of sinuses. J Physiol Pharmacol. 2007 Nov;58 Suppl 5(Pt 2):691-7.
- Background: PubMed 17014448Hopkins C, Browne JP, Slack R, Lund V, Topham J, Reeves B, Copley L, Brown P, van der Meulen J. The national comparative audit of surgery for nasal polyposis and chronic rhinosinusitis. Clin Otolaryngol. 2006 Oct;31(5):390-8. doi: 10.1111/j.1749-4486.2006.01275.x.
- Background: PubMed 29928924Leopold DA, Elkayam D, Messina JC, Kosik-Gonzalez C, Djupesland PG, Mahmoud RA. NAVIGATE II: Randomized, double-blind trial of the exhalation delivery system with fluticasone for nasal polyposis. J Allergy Clin Immunol. 2019 Jan;143(1):126-134.e5. doi: 10.1016/j.jaci.2018.06.010. Epub 2018 Jun 19.
- Background: PubMed 30337921Kobayashi Y, Yasuba H, Asako M, Yamamoto T, Takano H, Tomoda K, Kanda A, Iwai H. HFA-BDP Metered-Dose Inhaler Exhaled Through the Nose Improves Eosinophilic Chronic Rhinosinusitis With Bronchial Asthma: A Blinded, Placebo-Controlled Study. Front Immunol. 2018 Sep 25;9:2192. doi: 10.3389/fimmu.2018.02192. eCollection 2018.
- Background: PubMed 8028915Rice DH. Endoscopic sinus surgery. Otolaryngol Head Neck Surg. 1994 Jul;111(1):100-10. doi: 10.1177/019459989411100118. No abstract available.
- Background: PubMed 26624856Benninger MS, Sindwani R, Holy CE, Hopkins C. Impact of medically recalcitrant chronic rhinosinusitis on incidence of asthma. Int Forum Allergy Rhinol. 2016 Feb;6(2):124-9. doi: 10.1002/alr.21652. Epub 2015 Dec 1.
- Background: PubMed 27859303DeConde AS, Mace JC, Levy JM, Rudmik L, Alt JA, Smith TL. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2017 Mar;127(3):550-555. doi: 10.1002/lary.26391. Epub 2016 Nov 12.
- Background: PubMed 19671253Bhattacharyya N. Contemporary assessment of the disease burden of sinusitis. Am J Rhinol Allergy. 2009 Jul-Aug;23(4):392-5. doi: 10.2500/ajra.2009.23.3355.
- Background: PubMed 32172284Wahid NW, Smith R, Clark A, Salam M, Philpott CM. The socioeconomic cost of chronic rhinosinusitis study. Rhinology. 2020 Apr 1;58(2):112-125. doi: 10.4193/Rhin19.424.
- Background: PubMed 32415826Lourijsen ES, Fokkens WJ, Reitsma S. Direct and indirect costs of adult patients with chronic rhinosinusitis with nasal polyps. Rhinology. 2020 Jun 1;58(3):213-217. doi: 10.4193/Rhin19.468.
- 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.
Léa FATH, MD, PhD principal investigator
HUS
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 IHU Strasbourg at 1 site in France.
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 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: stopped early, as of the sponsor's last update on 8 Jan 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 France. 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 was stopped early (reason given: Number of inclusions sufficient for answering the main objective). Results are not available in the source record.
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?
Assessment of the global effect of Dupilumab 1 day before Dupilumab by the mean of the SNOT 22 score (time frame: 1 day before Dupilumab). 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?
On the ClinicalTrials.gov record for NCT06017427, which also lists 16 linked publications.
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 8 Jan 2024.