Study on Azithromycin for Treating Chronic Sinusitis in Adults

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What is this study about?

This clinical trial is focused on studying a condition known as chronic rhinosinusitis, which is a long-lasting inflammation of the sinuses that can cause symptoms like nasal congestion, facial pain, and a runny nose. The study is specifically looking at a type of chronic rhinosinusitis that is resistant to standard treatments and involves persistent pus-like discharge. The treatment being tested is a medication called azithromycin, which is an antibiotic commonly used to treat bacterial infections. Participants in the study will receive either azithromycin or a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate the effectiveness of a three-month continuous treatment with azithromycin in improving the quality of life for adults with this type of sinusitis. The study will involve regular assessments of participants’ symptoms and overall health. Participants will be monitored over the course of the treatment to see how their symptoms change and to ensure their safety.

Throughout the study, various aspects of the participants’ health will be measured, including the frequency of sinus infections, the need for additional antibiotics, and changes in symptoms. The study will also look at the impact of the treatment on participants’ daily lives, such as their ability to work and their sense of smell. The goal is to determine whether azithromycin can provide significant relief for those suffering from chronic rhinosinusitis.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes a review of medical history and a physical examination focusing on ear, nose, and throat health.

A nasal endoscopy and a CT scan will be performed to assess the condition of the sinuses. These tests help in confirming the presence of chronic rhinosinusitis.

2 consent and documentation

You will be asked to provide signed informed consent, indicating your understanding and agreement to participate in the trial.

Documentation of your health insurance membership or beneficiary status will be required.

3 treatment phase

The treatment phase involves taking the medication azithromycin orally. The dosage and frequency will be specified by the study team, and the treatment will last for a continuous period of 3 months.

During this phase, you will be required to take the medication as prescribed and report any side effects or changes in your condition.

4 regular monitoring

Throughout the treatment phase, regular monitoring will be conducted. This includes follow-up visits to assess your response to the medication and to monitor for any adverse effects.

You will be asked to complete the Sino-Nasal Outcome Test 22 (SNOT 22) to evaluate changes in your quality of life related to sinus symptoms.

5 final assessment

At the end of the 3-month treatment period, a final assessment will be conducted. This will include a repeat of the nasal endoscopy and CT scan to evaluate changes in your sinus condition.

You will also complete the SNOT 22 questionnaire again to assess any improvements in your quality of life.

6 post-treatment follow-up

After the treatment phase, there will be a follow-up period to monitor any residual effects of the treatment. This may involve additional questionnaires and assessments.

The study team will continue to monitor your health and any changes in your condition during this time.

Who Can Join the Study?

Patient must be older than 18 years and less than 70 years of age.
Patient must have chronic rhinosinusitis, which means a long-lasting inflammation of the sinuses, for more than 12 weeks. This should meet specific criteria seen in a nasal examination and a CT scan, showing certain changes in the sinuses.
Patient must have a persistent form of purulent rhinosinusitis, which means ongoing sinus infection with pus, that has not improved despite at least two courses of antibiotics.
Patient must provide signed informed consent, meaning they agree to participate in the study after understanding all the details.
Patient must be a member of a health insurance plan or be a beneficiary of one.

Who Cannot Join the Study?

Patients with any other significant health problems that are not related to ear, nose, and throat diseases.
Patients who are currently participating in another clinical trial.
Patients who have had surgery related to ear, nose, and throat diseases in the last 3 months.
Patients who are unable to follow the study procedures or attend follow-up visits.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy to any of the study medications.
Patients who are using medications that might interfere with the study results.
Patients with a history of drug or alcohol abuse.
Patients with a mental health condition that might affect their ability to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Cif Lbyxf	Lille	France
Czt Tzbmjnww	Toulouse	France
Cgn Mvaerfhpd	Marseille	France
Cjig Neyzf	Nancy	France
Cqj Ctjjl Rfcmynqvgwy	Lyon	France
Csg Ntisnq	Lyon	France
Csbexu Hsmvepvudxk Idolswtzukzqm dx Cwvubev	Creteil	France
Azybcahkbf Papyoyrg Hjzynqyl Du Pbijp	Paris	France
Hrzxuju Hfhhh Mqodyr &rduuza 1 rym Goroemp Eqetux	Creteil	France
Ckr Kkaqnnb Btutpda	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	21.11.2022

Trial locations

Investigated drugs:

Azithromycin

Azithromycin is an antibiotic that is used to treat various types of infections caused by bacteria. In this clinical trial, it is being tested for its effectiveness in treating a condition called idiopathic purulent oedematous sinusitis in adults. This condition involves inflammation and infection of the sinuses, leading to symptoms like nasal congestion, facial pain, and a runny nose. The trial aims to see if taking azithromycin continuously for three months can improve the quality of life for people suffering from this sinus condition by reducing these symptoms.

Investigated diseases:

Rhinosinusitis – Rhinosinusitis is an inflammation of the nasal passages and sinuses, often resulting in congestion, facial pain, and a reduced sense of smell. It can be caused by infections, allergies, or other factors that lead to swelling and blockage of the sinus openings. The condition may start with symptoms similar to a common cold, such as a runny nose and sneezing, but can progress to more severe discomfort and pressure in the face. Over time, the inflammation can lead to the accumulation of mucus, which may become infected, causing further symptoms like fever and fatigue. Chronic rhinosinusitis can persist for several weeks or longer, with symptoms fluctuating in intensity. The disease can significantly impact quality of life, affecting daily activities and overall well-being.

Trial ID:

2024-517239-33-00

Protocol code:

SOPAZITHRO

NCT ID:

NCT05157685

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Azithromycin for Treating Chronic Sinusitis in Adults

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