Chronic Rhinosinusitis (Diagnosis)NCT03369574
Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab
An observational study of Chronic Rhinosinusitis (Diagnosis) and Asthma, run by University of Rochester at 1 site in United States.
Trial summary
The primary objective of this research is to monitor chronic rhinosinusitis (CRS) symptoms in asthma patients who are undergoing treatment with reslizumab. A secondary objective is to explore whether there are sub-populations that appear to benefit or not benefit from reslizumab in terms of their CRS symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis), Asthma, Nasal Polyps
- What is being tested?
- Reslizumab
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 19 Oct 2018
- 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: Patients with poorly controlled moderate to severe asthma with eosinophilia and a diagnosis of chronic rhinosinusitis with nasal polyposis
Who may be able to join
- Age is 18 years or older
- Physician diagnosis of poorly controlled moderate to severe asthma despite typical medical therapy with an eosinophilic phenotype (defined by blood eosinophil count of 150 µL or greater within 6 weeks of enrollment)
- Initiating or undergoing reslizumab therapy (Reslizumab - Patient Information listed in Appendix 1 for reference)
- Physician diagnosis of chronic rhinosinusitis with nasal polyposis
- Able to understand and willing to provide informed consent
- Able to complete standard of care English-language questionnaires
Who cannot join
- Current smokers
- Significant uncontrolled medical conditions
- Ongoing malignancy or history of cancer in remission for less than 12 months
- Subjects who had received immunosuppressive medications within 3 months of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Department of Otolaryngology Head and Neck Surgery
Rochester, New York, 14642
About this study
Official title: Prospective Observational Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab
The primary objective of this research is to monitor chronic rhinosinusitis (CRS) symptoms in asthma patients who are undergoing treatment with reslizumab. A secondary objective is to explore whether there are sub-populations that appear to benefit or not benefit from reslizumab in terms of their CRS symptoms.
Read the detailed description
This is a prospective observational study of patients receiving reslizumab to treat their asthma. Some asthma patients receiving reslizumab also have CRS, which might also be improved by this drug. Study measures will be obtained from the medical records of eligible subjects who consent to participate. The study has no specific procedures per se, because all study measures are acquired during the course of standard of care treatment and will be abstracted from those medical records.
- Conditions
- Chronic Rhinosinusitis (Diagnosis), Asthma, Nasal Polyps
- Being tested
- Reslizumab
- Medical subject headings
- Disease, Asthma, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReslizumabDrug
reslizumab administration
| Study group | Role | What they receive |
|---|---|---|
| chronic rhinosinusitis and eosinophilic asthma | Adults over the age of 18, diagnosed with poorly controlled moderate to severe asthma with an eosinophilic phenotype (defined by blood eosinophil count of 150 µL or greater within 6 weeks of enrollment) who are initiating/undergoing reslizumab therapy and also carry a physician diagnosis of chronic rhinosinusitis with nasal polyposis Receives: Drug: Reslizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Sino-Nasal Outcome Test (SNOT)-22 Score
SNOT-22 score ranges from 0 to 110 with higher scores indicating worse symptoms. The questionnaire consists of 22 questions regarding common sinonasal complaints of patients with chronic sinus disease, each question graded 0 to 5 (0 No Problem, 1 Very Mild Problem, 2 Mild or Slight Problem, 3 Moderate Problem, 4 Severe Problem, 5 Problem as Bad as it Can Be).
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 posted12 Dec 2017
- Study start14 Nov 2017
- Primary completion19 Oct 2018
- Study completion19 Oct 2018
Why it stopped: Study personnel diverted to other activities and the study was not commenced
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Xing Man, University of Rochester
- Investigators
- Li-Xing Man, MSc, MD, MPA, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369574
- Sponsor's protocol ID
- RSRB 60712
- Status last verified
- Nov 2019
- First submitted
- 2 Dec 2017
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hastan D, Fokkens WJ, Bachert C, Newson RB, Bislimovska J, Bockelbrink A, Bousquet PJ, Brozek G, Bruno A, Dahlen SE, Forsberg B, Gunnbjornsdottir M, Kasper L, Kramer U, Kowalski ML, Lange B, Lundback B, Salagean E, Todo-Bom A, Tomassen P, Toskala E, van Drunen CM, Bousquet J, Zuberbier T, Jarvis D, Burney P. Chronic rhinosinusitis in Europe--an underestimated disease. A GA(2)LEN study. Allergy. 2011 Sep;66(9):1216-23. doi: 10.1111/j.1398-9995.2011.02646.x. Epub 2011 May 24.
PubMed 21605125Hamilos DL. Chronic rhinosinusitis: epidemiology and medical management. J Allergy Clin Immunol. 2011 Oct;128(4):693-707; quiz 708-9. doi: 10.1016/j.jaci.2011.08.004. Epub 2011 Sep 3.
PubMed 21890184Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, Orlandi RR, Palmer JN, Patel ZM, Peters A, Walsh SA, Corrigan MD. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015 Apr;152(2 Suppl):S1-S39. doi: 10.1177/0194599815572097.
PubMed 25832968Settipane GA, Chafee FH. Nasal polyps in asthma and rhinitis. A review of 6,037 patients. J Allergy Clin Immunol. 1977 Jan;59(1):17-21. doi: 10.1016/0091-6749(77)90171-3.
PubMed 833373Jarvis D, Newson R, Lotvall J, Hastan D, Tomassen P, Keil T, Gjomarkaj M, Forsberg B, Gunnbjornsdottir M, Minov J, Brozek G, Dahlen SE, Toskala E, Kowalski ML, Olze H, Howarth P, Kramer U, Baelum J, Loureiro C, Kasper L, Bousquet PJ, Bousquet J, Bachert C, Fokkens W, Burney P. Asthma in adults and its association with chronic rhinosinusitis: the GA2LEN survey in Europe. Allergy. 2012 Jan;67(1):91-8. doi: 10.1111/j.1398-9995.2011.02709.x. Epub 2011 Nov 4.
PubMed 22050239Bachert C, Zhang N, Holtappels G, De Lobel L, van Cauwenberge P, Liu S, Lin P, Bousquet J, Van Steen K. Presence of IL-5 protein and IgE antibodies to staphylococcal enterotoxins in nasal polyps is associated with comorbid asthma. J Allergy Clin Immunol. 2010 Nov;126(5):962-8, 968.e1-6. doi: 10.1016/j.jaci.2010.07.007.
PubMed 20810157Bachert C, Gevaert P, Holtappels G, Cuvelier C, van Cauwenberge P. Nasal polyposis: from cytokines to growth. Am J Rhinol. 2000 Sep-Oct;14(5):279-90. doi: 10.2500/105065800781329573.
PubMed 11068652Bachert C, Wagenmann M, Hauser U, Rudack C. IL-5 synthesis is upregulated in human nasal polyp tissue. J Allergy Clin Immunol. 1997 Jun;99(6 Pt 1):837-42. doi: 10.1016/s0091-6749(97)80019-x.
PubMed 9215253Bousquet J, Chanez P, Lacoste JY, Barneon G, Ghavanian N, Enander I, Venge P, Ahlstedt S, Simony-Lafontaine J, Godard P, et al. Eosinophilic inflammation in asthma. N Engl J Med. 1990 Oct 11;323(15):1033-9. doi: 10.1056/NEJM199010113231505.
PubMed 2215562Sanderson CJ. Interleukin-5, eosinophils, and disease. Blood. 1992 Jun 15;79(12):3101-9. No abstract available.
PubMed 1596561Takatsu K, Nakajima H. IL-5 and eosinophilia. Curr Opin Immunol. 2008 Jun;20(3):288-94. doi: 10.1016/j.coi.2008.04.001. Epub 2008 May 27.
PubMed 18511250Leckie MJ, ten Brinke A, Khan J, Diamant Z, O'Connor BJ, Walls CM, Mathur AK, Cowley HC, Chung KF, Djukanovic R, Hansel TT, Holgate ST, Sterk PJ, Barnes PJ. Effects of an interleukin-5 blocking monoclonal antibody on eosinophils, airway hyper-responsiveness, and the late asthmatic response. Lancet. 2000 Dec 23-30;356(9248):2144-8. doi: 10.1016/s0140-6736(00)03496-6.
PubMed 11191542Kips JC, O'Connor BJ, Langley SJ, Woodcock A, Kerstjens HA, Postma DS, Danzig M, Cuss F, Pauwels RA. Effect of SCH55700, a humanized anti-human interleukin-5 antibody, in severe persistent asthma: a pilot study. Am J Respir Crit Care Med. 2003 Jun 15;167(12):1655-9. doi: 10.1164/rccm.200206-525OC. Epub 2003 Mar 20.
PubMed 12649124Green RH, Brightling CE, McKenna S, Hargadon B, Parker D, Bradding P, Wardlaw AJ, Pavord ID. Asthma exacerbations and sputum eosinophil counts: a randomised controlled trial. Lancet. 2002 Nov 30;360(9347):1715-21. doi: 10.1016/S0140-6736(02)11679-5.
PubMed 12480423Jayaram L, Pizzichini MM, Cook RJ, Boulet LP, Lemiere C, Pizzichini E, Cartier A, Hussack P, Goldsmith CH, Laviolette M, Parameswaran K, Hargreave FE. Determining asthma treatment by monitoring sputum cell counts: effect on exacerbations. Eur Respir J. 2006 Mar;27(3):483-94. doi: 10.1183/09031936.06.00137704.
PubMed 16507847
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab
- ClinicalTrials.gov ID
- NCT03369574
- Acronym / sponsor ID
- RSRB 60712
- Conditions
- Chronic Rhinosinusitis (Diagnosis), Asthma, Nasal Polyps
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study personnel diverted to other activities and the study was not commenced
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 19 Oct 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 12 Dec 2017 (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.
The primary objective of this research is to monitor chronic rhinosinusitis (CRS) symptoms in asthma patients who are undergoing treatment with reslizumab. A secondary objective is to explore whether there are sub-populations that appear to benefit or not benefit from reslizumab in terms of their CRS symptoms.
Detailed description
This is a prospective observational study of patients receiving reslizumab to treat their asthma. Some asthma patients receiving reslizumab also have CRS, which might also be improved by this drug. Study measures will be obtained from the medical records of eligible subjects who consent to participate. The study has no specific procedures per se, because all study measures are acquired during the course of standard of care treatment and will be abstracted from those medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic rhinosinusitis and eosinophilic asthma | – | Drug: ReslizumabAdults over the age of 18, diagnosed with poorly controlled moderate to severe asthma with an eosinophilic phenotype (defined by blood eosinophil count of 150 µL or greater within 6 weeks of enrollment) who are initiating/undergoing reslizumab therapy and also carry a physician diagnosis of chronic rhinosinusitis with nasal polyposis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with poorly controlled moderate to severe asthma with eosinophilia and a diagnosis of chronic rhinosinusitis with nasal polyposis
Key inclusion criteria (6 listed)
- Age is 18 years or older
- Physician diagnosis of poorly controlled moderate to severe asthma despite typical medical therapy with an eosinophilic phenotype (defined by blood eosinophil count of 150 µL or greater within 6 weeks of enrollment)
- Initiating or undergoing reslizumab therapy (Reslizumab - Patient Information listed in Appendix 1 for reference)
- Physician diagnosis of chronic rhinosinusitis with nasal polyposis
- Able to understand and willing to provide informed consent
Key exclusion criteria (4 listed)
- Current smokers
- Significant uncontrolled medical conditions
- Ongoing malignancy or history of cancer in remission for less than 12 months
- Subjects who had received immunosuppressive medications within 3 months of enrollment
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 |
|---|---|---|
| Reslizumabreslizumab administration | Drug | chronic rhinosinusitis and eosinophilic asthma |
Primary outcome
Mean Sino-Nasal Outcome Test (SNOT)-22 Score
Time frame: 1 year
SNOT-22 score ranges from 0 to 110 with higher scores indicating worse symptoms. The questionnaire consists of 22 questions regarding common sinonasal complaints of patients with chronic sinus disease, each question graded 0 to 5 (0 No Problem, 1 Very Mild Problem, 2 Mild or Slight Problem, 3 Moderate Problem, 4 Severe Problem, 5 Problem as Bad as it Can Be).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Background: PubMed 21605125Hastan D, Fokkens WJ, Bachert C, Newson RB, Bislimovska J, Bockelbrink A, Bousquet PJ, Brozek G, Bruno A, Dahlen SE, Forsberg B, Gunnbjornsdottir M, Kasper L, Kramer U, Kowalski ML, Lange B, Lundback B, Salagean E, Todo-Bom A, Tomassen P, Toskala E, van Drunen CM, Bousquet J, Zuberbier T, Jarvis D, Burney P. Chronic rhinosinusitis in Europe--an underestimated disease. A GA(2)LEN study. Allergy. 2011 Sep;66(9):1216-23. doi: 10.1111/j.1398-9995.2011.02646.x. Epub 2011 May 24.
- Background: PubMed 21890184Hamilos DL. Chronic rhinosinusitis: epidemiology and medical management. J Allergy Clin Immunol. 2011 Oct;128(4):693-707; quiz 708-9. doi: 10.1016/j.jaci.2011.08.004. Epub 2011 Sep 3.
- Background: PubMed 25832968Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, Orlandi RR, Palmer JN, Patel ZM, Peters A, Walsh SA, Corrigan MD. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015 Apr;152(2 Suppl):S1-S39. doi: 10.1177/0194599815572097.
- Background: PubMed 833373Settipane GA, Chafee FH. Nasal polyps in asthma and rhinitis. A review of 6,037 patients. J Allergy Clin Immunol. 1977 Jan;59(1):17-21. doi: 10.1016/0091-6749(77)90171-3.
- Background: PubMed 22050239Jarvis D, Newson R, Lotvall J, Hastan D, Tomassen P, Keil T, Gjomarkaj M, Forsberg B, Gunnbjornsdottir M, Minov J, Brozek G, Dahlen SE, Toskala E, Kowalski ML, Olze H, Howarth P, Kramer U, Baelum J, Loureiro C, Kasper L, Bousquet PJ, Bousquet J, Bachert C, Fokkens W, Burney P. Asthma in adults and its association with chronic rhinosinusitis: the GA2LEN survey in Europe. Allergy. 2012 Jan;67(1):91-8. doi: 10.1111/j.1398-9995.2011.02709.x. Epub 2011 Nov 4.
- Background: PubMed 20810157Bachert C, Zhang N, Holtappels G, De Lobel L, van Cauwenberge P, Liu S, Lin P, Bousquet J, Van Steen K. Presence of IL-5 protein and IgE antibodies to staphylococcal enterotoxins in nasal polyps is associated with comorbid asthma. J Allergy Clin Immunol. 2010 Nov;126(5):962-8, 968.e1-6. doi: 10.1016/j.jaci.2010.07.007.
- Background: PubMed 11068652Bachert C, Gevaert P, Holtappels G, Cuvelier C, van Cauwenberge P. Nasal polyposis: from cytokines to growth. Am J Rhinol. 2000 Sep-Oct;14(5):279-90. doi: 10.2500/105065800781329573.
- Background: PubMed 9215253Bachert C, Wagenmann M, Hauser U, Rudack C. IL-5 synthesis is upregulated in human nasal polyp tissue. J Allergy Clin Immunol. 1997 Jun;99(6 Pt 1):837-42. doi: 10.1016/s0091-6749(97)80019-x.
- Background: PubMed 2215562Bousquet J, Chanez P, Lacoste JY, Barneon G, Ghavanian N, Enander I, Venge P, Ahlstedt S, Simony-Lafontaine J, Godard P, et al. Eosinophilic inflammation in asthma. N Engl J Med. 1990 Oct 11;323(15):1033-9. doi: 10.1056/NEJM199010113231505.
- Background: PubMed 1596561Sanderson CJ. Interleukin-5, eosinophils, and disease. Blood. 1992 Jun 15;79(12):3101-9. No abstract available.
- Background: PubMed 18511250Takatsu K, Nakajima H. IL-5 and eosinophilia. Curr Opin Immunol. 2008 Jun;20(3):288-94. doi: 10.1016/j.coi.2008.04.001. Epub 2008 May 27.
- Background: PubMed 11191542Leckie MJ, ten Brinke A, Khan J, Diamant Z, O'Connor BJ, Walls CM, Mathur AK, Cowley HC, Chung KF, Djukanovic R, Hansel TT, Holgate ST, Sterk PJ, Barnes PJ. Effects of an interleukin-5 blocking monoclonal antibody on eosinophils, airway hyper-responsiveness, and the late asthmatic response. Lancet. 2000 Dec 23-30;356(9248):2144-8. doi: 10.1016/s0140-6736(00)03496-6.
- 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.
Li-Xing Man, MSc, MD, MPA principal investigator
University of Rochester
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 (Diagnosis) and Asthma, run by University of Rochester at 1 site in United States.
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 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: withdrawn, as of the sponsor's last update on 13 Nov 2019. 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 United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Mean Sino-Nasal Outcome Test (SNOT)-22 Score (time frame: 1 year). 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 NCT03369574, which also lists 19 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 13 Nov 2019.