New Clinical Research Study on Nasal Polyps (SYNAPSE)
Study Location: 3000 N. Halsted Office, Chicago, Illinois 60657
A nasal polyp is a painless, noncancerous tumor that grows in the lining of the nose or sinuses. Nasal polyps tend to develop in patients who suffer from allergies, asthma, chronic nasal and sinus infections, cystic fibrosis, certain immune disorders, and sensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs). These polyps may resolve on their own once the infection and inflammation clears or they may remain and grow larger in size.
Research also suggests that patients that have nasal polyps can develop a sinus infection as polyps tend to obstruct proper sinus drainage. (For more information on nasal polyps, read our latest blog article, “Are You at Risk for Developing Nasal Polyps?”).
Chicago ENT is currently conducting a clinical research study (SYNAPSE) to investigate the effectiveness of an investigational drug for severe nasal polyps. Study participants will receive study medication at no cost.
What is the SYNAPSE Study?
SYNAPSE is a randomised, double-blind, parallel group Ph III study to assess the clinical efficacy and safety of 100 mg SC Mepolizumab as an add on to maintenance treatment in adults with severe bilateral nasal polyps- SYNAPSE (StudY NAsal Polyps patient to assess the Safety and Efficacy of mepolizumab (Nucala)).
To Qualify for this Study Participants Must:
- Be at least eighteen (18) years of age
- Have had a history of prior nasal polyp surgery in the last 10 years
- Must be diagnosed with bilateral severe nasal polyp disease for which you are currently being treated
What is the Cost to Participate in the Nasal Polyp Study?
There are no medical costs associated to participate in this research study. Participants may receive some compensation for time and travel.
- Patients that have cystic fibrosis
- Eosinophilic granulomatosis with polyangiitis, Young’s, Kartagener’s or dyskinetic ciliary syndromes
- Antrochoanal polyps
- Nasal septal deviation occluding one nostril
- Acute sinusitis or URTI within 2 weeks
- Asthma exacerbation requiring admission within 4 weeks
- Intranasal and/or sinus surgery within 6 months
- Allergy to anti-IL-5 or other monoclonal antibody therapy
- On a waiting list (i.e., surgery schedule) for NP surgery (and not willing to come off the schedule)
- Use of systemic corticosteroids (including oral corticosteroids) or corticosteroid nasal solution (intranasal corticosteroid is excepted) within 4 weeks
- INCS dose changes within 1 month
- Leukotriene antagonist treatment less than 30 days
- Allergen immunotherapy within the previous 3 months
- Current smoker or have smoked in the last 6 months
What Does the SYNAPSE Study Entail and How Much Time Will I Have to Spend?
After enrollment, subject will undergo 12-monthly subcutaneous injections of 100 mg mepolizumab or placebo as add-on therapy to a stable regimen of their current medications. Subjects can be placed on a surgical waiting list after the two months if deemed appropriate by ENT. Surgically-treated patient will continue to be followed for the duration of the study.
If you are interested, please contact Chicago ENT at 773.296.5500.