In short
There are currently 2 ongoing clinical trials investigating new treatments for chronic sinusitis. These studies are exploring different medication approaches to help adults whose symptoms have not improved with standard treatments, testing both antibiotic and anti-inflammatory options to reduce inflammation and improve quality of life.
Clinical trial locations
- Belgium
- Bulgaria
- France
- Germany
- Hungary
- Poland
Study on Azithromycin for Treating Chronic Sinusitis in Adults
This trial is testing whether azithromycin, a commonly used antibiotic, can help adults suffering from a persistent form of sinus infection that has not responded to standard treatments. The study focuses on a type of chronic sinusitis characterized by ongoing pus-like discharge and inflammation lasting more than 12 weeks.
Who can participate:
- Adults between 18 and 70 years old
- People with chronic inflammation of the sinuses lasting more than 12 weeks, confirmed by nasal examination and CT scan
- Patients with ongoing purulent (pus-filled) sinus infection that has not improved despite at least two courses of antibiotics
- Those with health insurance coverage
Who cannot participate:
- Patients with other significant health problems unrelated to ear, nose, and throat conditions
- Those currently in another clinical trial
- Patients who had ear, nose, or throat surgery in the last 3 months
- Pregnant or breastfeeding women
- People with known allergies to the study medications
- Those with mental health conditions or substance abuse history that might affect participation
What the trial involves: Participants will take azithromycin orally for a continuous period of 3 months, or receive a placebo. Throughout the study, they will have regular monitoring visits, complete questionnaires about their symptoms and quality of life, and undergo nasal examinations and CT scans to track changes in their sinus condition. The main goal is to determine whether this extended antibiotic treatment can significantly improve quality of life, reduce the frequency of sinus infections, and lessen the need for additional antibiotics.
Investigational drug: Azithromycin is an antibiotic that works by stopping the growth of bacteria. It is commonly used to treat various bacterial infections affecting the ear, nose, and throat. In this trial, researchers are studying whether a 3-month continuous treatment can reduce inflammation and infection in the sinuses, leading to symptom relief.
Study on the Effectiveness and Safety of LYR-210 and Dexamethasone for Treating Chronic Sinusitis in Adults Without Nasal Polyps
This international trial is evaluating a treatment system called LYR-210, which delivers anti-inflammatory medication directly into the nasal passages. The study focuses on adults with chronic sinusitis who do not have nasal polyps and have not found relief from previous medical treatments.
Who can participate:
- Adults 18 years or older
- People diagnosed with chronic rhinosinusitis affecting the ethmoid sinuses on both sides, confirmed by CT scan
- Patients with a certain level of symptom severity based on the three main symptoms: nasal blockage, facial pain, and nasal discharge
- Those who have tried at least two different medical treatments in the past
- Participants willing to postpone any planned sinus surgery during the study
Who cannot participate:
- Patients with nasal polyps (soft growths inside the nose or sinuses)
- Those who have never tried medical treatments for their condition
- Pregnant or breastfeeding women
- People with other serious health problems that might interfere with the study
- Those unable to follow study procedures or attend required visits
What the trial involves: The LYR-210 System is administered as an implant placed in the nasal cavity, designed to release anti-inflammatory medication over time directly at the site of inflammation. The treatment period lasts 24 weeks, during which participants will have regular monitoring visits to assess changes in their symptoms. Researchers will track improvements in nasal congestion, facial pain, nasal discharge, and overall quality of life using standardized questionnaires. The treatment is compared to a sham (fake) procedure to determine its true effectiveness.
Investigational drugs: The study involves two anti-inflammatory medications: mometasone furoate (the active substance in the LYR-210 System) and dexamethasone. These medications work by reducing inflammation in the sinus tissues. The LYR-210 implant delivers the medication directly to the affected area over an extended period, potentially providing more targeted and sustained relief than traditional oral or nasal spray medications.
Summary
The two ongoing clinical trials for chronic sinusitis represent different treatment approaches. One trial in France is testing a prolonged antibiotic treatment with azithromycin for patients with persistent purulent sinusitis, while the other is a multi-country European study (Germany, Poland, Belgium, Hungary, and Bulgaria) focusing on a localized anti-inflammatory implant system for patients without nasal polyps.
Both studies target adults whose symptoms have not improved with standard treatments, reflecting the challenge of managing treatment-resistant chronic sinusitis. The trials differ in their approach: one uses a systemic antibiotic to address bacterial infection, while the other delivers anti-inflammatory medication directly to the affected sinuses. These studies aim to provide new treatment options for patients struggling with this chronic condition that significantly affects daily life and overall well-being.
