Chronic Rhinosinusitis With Nasal PolypsPhase 4NCT06556264
Immunologic Impact of Dupilumab in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps
A Phase 4 study testing Dupilumab in people with Chronic Rhinosinusitis With Nasal Polyps and Asthma, run by Dr. Andrew Thamboo, MD.
Trial summary
The investigators are studying adults who have chronic rhinosinusitis with nasal polyps (CRSwNP) and moderate to severe asthma, and who are undergoing Endoscopic Sinus Surgery (ESS). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps, Asthma
- What is being tested?
- Dupilumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2025
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 19.
- Patients undergoing Endoscopic Sinus Surgery (ESS)
- Patients with CRSwNP with moderate-severe asthma according to 2020 EPOS criteria:
- Asthma confirmed with spirometry and assessment on the previous history of asthma (a methacholine challenge test and atopy testing to document the positive or negative history of asthma will be performed if there is no clinical record). Asthma severity based on GINA guidelines.
- Presence of nasal polyps. This can be based on the formal exam at Baseline Visit or historical assessment.
Who cannot join
- Patients with current or past sinonasal or bronchial tumours
- Subjects who have been treated with oral antibiotics in the past month prior to surgery
- Subjects with known immunodeficiency
- Subjects with known autoimmune disease
- Subjects with other sinonasal diseases other than CRSwNP (e.g., cystic fibrosis, eosinophilic granulomatosis with polyangiitis, allergic fungal rhinosinusitis, invasive fungal sinusitis, fungal ball, dyskinetic cilia syndrome)
- Prior lung transplants
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- Subjects with hypersensitivity; with allergy/intolerance to a monoclonal antibody or biologic
- Prior use of dupilumab or other biologic medications (omalizumab. mepolizumab, reslizumab,etc) 6 months before enrollment.
- Any condition that, in the opinion of the investigator, may interfere with the patient's ability to participate in the study per protocol.
- Participation in an ongoing interventional or observational study using a biologic treatment.
- Female participants who are pregnant or breastfeeding
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Determining the Immunologic Impact of Dupilumab on the Unified Airway System in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps
The investigators are studying adults who have chronic rhinosinusitis with nasal polyps (CRSwNP) and moderate to severe asthma, and who are undergoing Endoscopic Sinus Surgery (ESS). Investigators want to understand how adding a medication called dupilumab to their usual treatment affects inflammation in their upper and lower airways over 24 weeks.
Dupilumab works by blocking certain signals in the immune system that contribute to inflammation in both the sinuses and the lungs. By studying how this medication changes the immune profiles of both airway systems, investigators hope to learn more about the underlying causes of airway inflammation in these conditions.
This research is important because it may help understand if treating inflammation in one part of the airway (like the lungs) has a similar effect on inflammation in another part (like the sinuses). This could lead to better treatments for people with CRSwNP and asthma, targeting the root causes of their symptoms more effectively.
Read the detailed description
In adult patients with CRSwNP with concomitant moderate-severe asthma undergoing Endoscopic Sinus Surgery (ESS), what is the change in the inflammatory cascade in the upper and lower airways from patients treated with 300 mg of dupilumab twice daily for 24 weeks as an add-on treatment to the standard of care (intranasal corticosteroids, INCS+ backgroung asthma medication) compare to the placebo + standard of care treatment only.
The investigators hypothesize that the study of the immune profile in patients with CRSwNP and asthma would give a better understanding of the mechanism involved in the airway inflammatory response. Determining the molecular profiles of the upper and lower airways after dupilumab treatment has not been studied yet.
Dupilumab has demonstrated effectiveness in treating both Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and asthma, conditions characterized by Type 2 inflammation, by inhibiting the IL-4 and IL-13 signalling pathways. However, it remains unclear how immunological changes occur in paired tissues of the upper (sinus) and lower (lung) airways in patients treated with biologics compared to those receiving standard therapies. Additionally, it is not well understood whether improvements in one airway system (e.g., the lungs) are mirrored in the other (e.g., the sinuses), which could result in differing clinical responses. This study aims to address these gaps by examining the comparative effects of Dupilumab versus standard treatments on both airway systems, to determine if therapeutic effects are consistently observed across both systems and to understand the potential implications for clinical responsiveness.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps, Asthma
- Being tested
- Dupilumab, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called dupixent
Dupilumab 300mg every 2 weeks for 24 weeks
PlaceboOther
Placebo 300mg every 2 weeks for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Active comparator | 30 subjects undergoing ESS + dupilumab 300 (1-week post-surgery) every 2 weeks + standard of care treatment (INCS + background asthma medication) for 24 weeks Receives: Drug: Dupilumab |
| Placebo | Placebo comparator | 30 subjects undergoing ESS + placebo (1-week post-surgery) every 2 weeks + standard of care treatment (INCS + background asthma medication) for 24 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cytokine levels such as GM-CSF, IFNg, TNFa, VEGF-A, Identification of Key Interleukins and chemokynes (10/CXCL10, MIP-1a/CCL3, RANTES/CCL5), compared with placebo in CRSwNP and asthma patients from baseline to week 24
Change in GM-CSF, IFNg, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12 (p40), IL-13, IL-17A, IP-10/CXCL10, MIP-1a/CCL3, RANTES/CCL5, TNFa, VEGF-A compared with placebo in CRSwNP and asthma patients from baseline to week 24
Measured: From baseline to 24 weeks.
Secondary outcomes (3)
Changes in SNOT-22, ACQ-5 and Sniffin Stick Test
Relation of changes in the inflammatory profiles with changes in symptom control (SNOT-22, ACQ-5,Sniffin Stick test) compared with placebo at baseline and 24 weeks.
Measured: 24 weeks
Relation of changes in inflammatory profile with changes in endoscopic scores (MLK)
Correlate the changes in the inflammatory profiles with changes in endoscopy scores (MLK scores) compared with placebo at baseline and 24 weeks.
Measured: 24 weeks
Relation of inflammatory profile and (FeNO and nasal FeNO)
Correlate the changes in the inflammatory profiles with changes in the pulmonary function measured by spirometry FEV1 values and standard and nasal fractional exhaled nitric oxide (FeNO and nasal FeNO) compared with placebo at baseline and 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Andrew Thamboo, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor-investigator, Dr. Andrew Thamboo, MD, St. Paul's Sinus Centre
- Investigators
- Andrew Thamboo, Principal investigator, St Paul's Sonis Centre Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556264
- Sponsor's protocol ID
- H24-00189
- Status last verified
- Aug 2024
- First submitted
- 8 Jul 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Immunologic Impact of Dupilumab on the Unified Airway System in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps
- ClinicalTrials.gov ID
- NCT06556264
- Acronym / sponsor ID
- H24-00189
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps, Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr. Andrew Thamboo, MDUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Aug 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Aug 2024 (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 investigators are studying adults who have chronic rhinosinusitis with nasal polyps (CRSwNP) and moderate to severe asthma, and who are undergoing Endoscopic Sinus Surgery (ESS). Investigators want to understand how adding a medication called dupilumab to their usual treatment affects inflammation in their upper and lower airways over 24 weeks.
Dupilumab works by blocking certain signals in the immune system that contribute to inflammation in both the sinuses and the lungs. By studying how this medication changes the immune profiles of both airway systems, investigators hope to learn more about the underlying causes of airway inflammation in these conditions.
This research is important because it may help understand if treating inflammation in one part of the airway (like the lungs) has a similar effect on inflammation in another part (like the sinuses). This could lead to better treatments for people with CRSwNP and asthma, targeting the root causes of their symptoms more effectively.
Detailed description
In adult patients with CRSwNP with concomitant moderate-severe asthma undergoing Endoscopic Sinus Surgery (ESS), what is the change in the inflammatory cascade in the upper and lower airways from patients treated with 300 mg of dupilumab twice daily for 24 weeks as an add-on treatment to the standard of care (intranasal corticosteroids, INCS+ backgroung asthma medication) compare to the placebo + standard of care treatment only.
The investigators hypothesize that the study of the immune profile in patients with CRSwNP and asthma would give a better understanding of the mechanism involved in the airway inflammatory response. Determining the molecular profiles of the upper and lower airways after dupilumab treatment has not been studied yet.
Dupilumab has demonstrated effectiveness in treating both Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and asthma, conditions characterized by Type 2 inflammation, by inhibiting the IL-4 and IL-13 signalling pathways. However, it remains unclear how immunological changes occur in paired tissues of the upper (sinus) and lower (lung) airways in patients treated with biologics compared to those receiving standard therapies. Additionally, it is not well understood whether improvements in one airway system (e.g., the lungs) are mirrored in the other (e.g., the sinuses), which could result in differing clinical responses. This study aims to address these gaps by examining the comparative effects of Dupilumab versus standard treatments on both airway systems, to determine if therapeutic effects are consistently observed across both systems and to understand the potential implications for clinical responsiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Active comparator | Drug: Dupilumab30 subjects undergoing ESS + dupilumab 300 (1-week post-surgery) every 2 weeks + standard of care treatment (INCS + background asthma medication) for 24 weeks |
| Placebo | Placebo comparator | Other: Placebo30 subjects undergoing ESS + placebo (1-week post-surgery) every 2 weeks + standard of care treatment (INCS + background asthma medication) for 24 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over the age of 19.
- Patients undergoing Endoscopic Sinus Surgery (ESS)
- Patients with CRSwNP with moderate-severe asthma according to 2020 EPOS criteria:
Key exclusion criteria (11 listed)
- Patients with current or past sinonasal or bronchial tumours
- Subjects who have been treated with oral antibiotics in the past month prior to surgery
- Subjects with known immunodeficiency
- Subjects with known autoimmune disease
- Subjects with other sinonasal diseases other than CRSwNP (e.g., cystic fibrosis, eosinophilic granulomatosis with polyangiitis, allergic fungal rhinosinusitis, invasive fungal sinusitis, fungal ball, dyskinetic cilia syndrome)
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 |
|---|---|---|
| DupilumabAlso: dupixentDupilumab 300mg every 2 weeks for 24 weeks | Drug | Dupilumab |
| PlaceboPlacebo 300mg every 2 weeks for 24 weeks | Other | Placebo |
Primary outcome
Change in Cytokine levels such as GM-CSF, IFNg, TNFa, VEGF-A, Identification of Key Interleukins and chemokynes (10/CXCL10, MIP-1a/CCL3, RANTES/CCL5), compared with placebo in CRSwNP and asthma patients from baseline to week 24
Time frame: From baseline to 24 weeks.
Change in GM-CSF, IFNg, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12 (p40), IL-13, IL-17A, IP-10/CXCL10, MIP-1a/CCL3, RANTES/CCL5, TNFa, VEGF-A compared with placebo in CRSwNP and asthma patients from baseline to week 24
3 secondary outcomes
Changes in SNOT-22, ACQ-5 and Sniffin Stick Test
Time frame: 24 weeks
Relation of changes in inflammatory profile with changes in endoscopic scores (MLK)
Time frame: 24 weeks
Relation of inflammatory profile and (FeNO and nasal FeNO)
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- 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.
Andrew Thamboo principal investigator
St Paul's Sonis Centre Director
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dupilumab in people with Chronic Rhinosinusitis With Nasal Polyps and Asthma, run by Dr. Andrew Thamboo, MD.
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 11 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Thamboo (604-250-4174, andrew.thamboo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cytokine levels such as GM-CSF, IFNg, TNFa, VEGF-A, Identification of Key Interleukins and chemokynes (10/CXCL10, MIP-1a/CCL3, RANTES/CCL5), compared with placebo in CRSwNP and asthma patients from baseline to week 24 (time frame: From baseline to 24 weeks.). 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 16 Aug 2024.