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Dupilumab for Allergic Fungal Sinusitis (ADAPT Trial)
ADAPT Trial Summary
This trial will test whether dupilumab is an effective treatment for people with AFRS who have undergone sinus surgery.
ADAPT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowADAPT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ADAPT Trial Design
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Who is running the clinical trial?
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- You have taken any experimental medication within 30 days before the study starts.I have been on a stable dose of leukotriene antagonists for over 30 days.You have a positive skin or blood test for environmental allergies.I am able to understand and sign the consent form.I am scheduled to take corticosteroids during the study, but only as part of a planned surgery.I do not have major health issues that could affect the study results.I haven't taken any experimental or approved antibody drugs in the last 6 months or longer.I have nasal polyps and am choosing to have sinus surgery for suspected fungal sinusitis.You have been diagnosed with nasal polyps according to specific criteria.I cannot have sinus surgery because of other health issues.My condition didn't improve after using nasal sprays, oral steroids, and saline irrigation for the specified durations.This criterion may be incomplete or unclear. Can you please provide more context or clarify the criterion so that I can accurately summarize it for you?Fungi found in tissue samples.I have nasal polyps.I do not have conditions that prevent nasal exams, like severe nasal blockage or tumors.I have previously used dupilumab.I am over 18 years old.Your CT scan shows signs of sinus inflammation at the time of enrollment.I cannot tolerate nasal wash treatments.I've needed steroids or was hospitalized for asthma in the last 4 weeks.I rely on corticosteroids for a health condition.I am not allergic to dupilumab and have not had a live vaccine or worm infection recently.I haven't taken antibiotics for an infection in the last 4 weeks, except for those related to surgery.I have not had nasal or sinus surgery in the last 3 months.I have not received immunoglobulin or blood products in the last 30 days.I started allergy shots less than 3 months ago or plan to start or change the dose during the study.You are suspected to have allergic fungal rhinosinusitis based on specific criteria.Patients must meet at least 3 out of 5 criteria when they join the study.Specific results from a CT scan.You have a SNOT-22 score of at least 20 when you join the study.I haven't taken immunosuppressive medication in the last 3 months.
- Group 1: Placebo
- Group 2: Dupilumab
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are participants of this trial required to be a certain age?
"The age limit for this particular study is 18 to 99, as opposed to the 4 studies that only allow participants that are under 18 and the 51 studies for those over 65."
Are there any specific requirements for participants in this research project?
"Eligibility criteria for this study include a diagnosis of allergic fungal rhinosinusitis and being between 18-99 years old. A total of 132 people will be accepted into the trial."
Are there any harmful side-effects associated with Dupilumab 300 MG/2 ML Subcutaneous Solution?
"Dupilumab 300 MG/2 ML Subcutaneous Solution is considered safe. Because this is a Phase 3 trial, there is data supporting both efficacy and safety."
What are we hoping to achieve with this research?
"The primary outcome of this trial is to evaluate the efficacy of dupilumab in controlling sinonasal inflammation and preventing nasal polyp recurrence after complete sinus surgery for allergic fungal rhinosinusitis (AFRS) by using the modified Lund-Kennedy score. Secondary outcomes include the prevalence of revision sinus surgery for recurrent nasal polyps and the comparison of survival curves, which is defined as the documentation of the number of revision sinus surgery per participant that are deemed clinically necessary for the treatment of an acute exacerbation of chronic rhinosinusitis (AECRS). The study will also assess the change"
Are there any inclusion criteria for this research?
"Evidently, this trial is not looking for more patients as it was last updated on September 15th, 2022. This is according to the information provided on clinicaltrials.gov. Although this study is not currently recruiting, there are 56 other studies that are."
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