A Phase 4 interventional study of Dupilumab in Nasal Polyps, Sinusitis and Chronic Disease, sponsored by Madigan Army Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by Madigan Army Medical Center · Phase 4, Interventional, and Treatment
Investigators will investigate an alternate Dupilumab administration schedule in patients with recurrent chronic rhinosinusitis with nasal polyposis, who have a history of full endoscopic sinus surgery and are on appropriate topical medical therapies. Specifically, investigators will investigate if the alternate schedule of drug administration is non-inferior in both subjective and objective outcomes.
Dupixent was recently approved by the FDA for chronic rhinosinusitis patients with nasal polyposis in April 2019. Literature support for this approval comes from results obtained from a landmark Phase III trial (LIBERTY SINUS-24 and SINUS-52) that were published in November 2019. The data suggests that Dupilumab improves subjective quality of life significantly in patients with chronic sinusitis with nasal polyposis and there is objective evidence of decreased disease burden and severity of other comorbidities (asthma, aspirin exacerbated respiratory disease). Therefore, there is robust scientific evidence supporting the use of this medication in chronic rhinosinusitis with nasal polyposis patients along with the FDA indication for usage of this medication in this subset of patients.
Otolaryngologists see and manage most (if not all) of chronic sinusitis patients with persistent symptoms and give recommendations for surgical and medical therapies. Given our unique ability to perform a detailed examination and provide medical and surgical care, investigators believe that this patient population will be best served with us making the determination of when to initiate the treatment if other treatment strategies fail. Given the cost associated with this medication (\~ $45,630/patient/year based on price of $1,755/injection), investigators can make the judicious determination for when to prescribe this medication based on published evidence and guidelines in literature.
After careful assessment of LIBERTY study, most subjective and objective outcomes appear to show statistically and clinically significant benefit after 8 weeks of therapy. Moreover, one of the study arms had patients on this medication every 2 weeks until 26 weeks and then switched to every 4 weeks for the rest of the year. Given the apparent benefit of medication compared to placebo at 8 weeks, investigators propose that an alternate medication schedule with less frequent dosing after 8 weeks will be just as effective in improving subjective and objective outcomes in this patient population. If a non-inferior improvement is noted in the alternate medication schedule, then this will translate into significant cost saving to DoD and DHA (\~$21,000/patient/year) when patients are placed on this medication due to the refractory nature of their disease.
Moreover, if the alternate schedule is just as effective, then this will validate use of this schedule in active duty service members (ADSM) during temporary duty or deployments to keep them medically fit and ready. Although topical steroid rinses are beneficial after surgery, the lack of distilled water in some austere environments prohibit usage and some patients have disease recurrence despite steroids and therefore require alternate medications or additional surgery. If the alternate regimen is proven to be non-inferior, then ADSMs or their medical team can carry the pre-made medication with them while following appropriate storage instructions according to drug information. Based on the FDA information website, Dupilumab can be stored below the room temperature (\<77F or \<25C) in pre-filled syringes up to 14 days or within refrigerator (between 2-8 C) until expiration. As long as these storage conditions can be met, ADSMs can continue this regimen while they are away. Additionally, if they are stable on long term Dupilumab therapy, there is potential for even longer time intervals between injections to help manage their chronic disease process.
415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 313 interventional studies indexed under Sinusitis.
Browse Sinusitis studies →Madigan Army Medical Center is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
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Eligibility: patients =>18 years old with recurrent chronic rhinosinusitis with nasal polyposis (CRSwNP) despite standard of care (i.e topical medical therapies and full endoscopic sinus surgery)
Inclusion criteria:
Exclusion Criteria:
Eligible patient will receive 300 mg Subcutaneous Dupilumab every 2 weeks for 28 weeks
Biological: Dupilumab
Eligible patient will receive 300 mg Subcutaneous Dupilumab every 2 weeks for 8 weeks and then every 4 weeks up until 28 weeks
Biological: Dupilumab
Dupilumab is an anti-IL 4-13 biologic therapy that has been recently approved for use in recurrent chronic rhinosinusitis with nasal polyposis.
Also known as: Dupixent
Change in Sinonasal outcome test - 22 over different time intervals
22 item questionnaire of impact of chronic rhinosinusitis on quality of life. Scored from 0-120: higher number = worse symptoms
Time frame: Baseline, week 4, week 8, week 16 and week 28
Change in Lund Kennedy Score over different time intervals
Sinus endoscopy to objectively score the impact of drug on patient's disease process. Total points = 20 (10 on each side), higher score = worse objective data
Time frame: Baseline, week 4, week 8, week 16 and week 28
Change in Total polyp score over different time intervals
Sinus endoscopy to objectively score the impact of drug on patient's disease process. Scored from 0-8, 4 on each side. Higher scores = worse polyp scores
Time frame: Baseline, week 4, week 8, week 16 and week 28
Change in Rhinosinusitis Disability Index Score (RSDI) over different time intervals
Disability associated with chronic rhinosinusitis, Scored from 0-120: higher number = worse quality of life.
Time frame: Baseline, week 4, week 8, week 16 and week 28
Change in IgE levels over different time intervals
Labs to evaluate the impact of Dupilimab administration in patients
Time frame: Baseline, week 4, week 8, week 16 and week 28
Change in Eosinophil levels over different time intervals
Labs to evaluate the impact of Dupilimab administration in patients
Time frame: Baseline, week 4, week 8, week 16 and week 28
Cost Savings between 2 treatment arms
Cost savings between the two treatment arms will be compared to see how cost to healthcare was saved with alternate therapy.
Time frame: Ove the course of the study timeline - 28 weeks
Need for additional interventions or surgeries in each arm
We will assess if participants needed oral steroids or surgeries while being on dupixent therapy over the course of study to help manage their symptoms.
Time frame: Over the course of the study timeline - 28 weeks
Plan to share: No — The IPD information will only be available to the researchers participating in this multi-site trial. No outside researcher will be able to view this data or information.
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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