Evaluation of the Efficacy of Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults

NCT05157685 | Recruiting Phase 3

• 2 other identifiers: SOPAZITHRO2020-001227-13
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 13

Brief Summary

Purulent Oedematous Sinusitis (POS) is a particular form of chronic rhinosinusitis observed in 2% of the general population. In spite of its heavy impact on the quality of life, There is no established recommendation for the treatment of primary POS. Long-term low-dose macrolides are currently proposed for these forms of chronic rhinosinusitis when conventional treatments (local corticosteroids, saline rinsing, iterative short courses of antibiotics targeted on pathogens, and surgical opening and drainage) have failed. This treatment with macrolides is currently applied off-label. This study aims to assess the efficacy of macrolides in POS. An extensive workup is fulfilled to exclude other forms of chronic rhinosinusitis (Th2 biased inflammatory diseases, allergic diseases) (allergy, nasosinusal polyposis) or those due to cystic fibrosis or immune deficiency.

Conditions

Sinusitis, Chronic; Sinus Infection Chronic

Outcome Measures

Primary Outcomes (1)

• Comparison of sinonasal outcome test (SNOT) 22

  Comparison of the means of the Sinonasal Outcome Test (SNOT 22) specific quality of life scores after 3 months of treatment. (min = 0, max = 110)

  3 months

Secondary Outcomes (21)

• Number of infectious rhinosinus exacerbations

  3 months

• Number of courses of antibiotics used

  3 months

• Visual analog scales of symptoms

  6 months

• Semi-quantitative symptom scale

  6 months

• Semi-quantitative nasal endoscopy score

  6 months

Study Arms (2)

Azithromycin oral tablet

EXPERIMENTAL

Azithromycin 250 mg once daily morning or evening (with or without meals)

Drug: Azithromycin Oral Tablet

Placebo

PLACEBO COMPARATOR

Placebo once daily morning or evening (with or without meals)

Drug: Placebo

Interventions

Azithromycin Oral Tablet DRUG

Treatment assigned by randomization will be prescribed immediately. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the morning or evening for 3 months.

Also known as: active arm

Azithromycin oral tablet

Placebo DRUG

Treatment assigned by randomization will be prescribed immediately. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the morning or evening for 3 months.

Also known as: comparator arm

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient older than 18 years and less than 70 years of age
• Chronic rhinosinusitis (\> 12 weeks of evolution) meeting the definition published in the European Paper Position2012 (1) and corresponding exclusively to the following endoscopic and CT criteria:
• Nasal endoscopy showing bilateral and diffuse involvement associating edema of the mucosa of the nasal cavities and meatus with the presence of mucopurulent secretions in these areas
• Nasosinus CT scan showing diffuse and bilateral pansinus opacities involving at least the maxillary sinuses and the anterior and posterior ethmoids
• Persistent intractable purulent rhinosinusitis despite at least 2 antibiotic therapies
• Signed informed consent of the patient
• Membership in a health insurance plan or beneficiary

You may not qualify if:

• Pregnancy or breastfeeding
• PCOS of identified primary cause (identified immune deficiency, cystic fibrosis, HIV)
• Chronic non-purulent rhinosinusitis (nasosinusal polyposis, allergic rhinosinusitis)
• Localized chronic suppurative rhinosinusitis (single sinus, unilateral, frontal or maxillary or sphenoidal)
• Severe hepatic insufficiency (factor V level \< 50%)
• Severe renal insufficiency (stage 4 (GFR \< 30 ml/min/1.73 m2) and/or creatinine \< 40 ml/min)
• Severe heart failure (old age, ischemic heart disease, episode of recurrent cardiac arrest; hypotension, NYHA functional stage III-IV; widened QRS, complex ventricular arrhythmias; hyponatremia (Na \<135mmol/l); stage 4 renal failure (GFR \< 30 ml/min/1.73 m2); severely depressed LVEF (\< 30%)
• Documented moderate pre-existing sensorineural hearing loss with a mean pure tone threshold in the poorer ear in bone conduction \>30 dB across all 3 frequencies (500, 1000 and 2000 Hz) or in only one ear (unilateral deafness).
• Major cognitive impairment or lack of French language skills preventing completion of SNOT-22 and SF-36 questionnaires
• Patient with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)
• Patient with peanut or soy allergy
• Patient allergic to macrolides
• Patients who are intolerant or allergic to any of the excipients of azithromycin or placebo
• Treatment with azithromycin in the previous 3 months
• Long QT on ECG ((\>440ms for male and \>450ms for female) or cardiac arrhythmia or bradycardia (\<60btm).The calculation of the corrected QT should be carried out using the Bazett formula.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (13)

CHU Bordeaux

Bordeaux, France

NOT YET RECRUITING

Hôpital Henri Mondor

Créteil, 94010, France

RECRUITING

CHU Bicêtre, AP-HP

Le Kremlin-Bicêtre, France

RECRUITING

CHU Lille

Lille, 59000, France

RECRUITING

CHU de la Croix Rousse

Lyon, France

RECRUITING

Hospices de Lyon

Lyon, France

RECRUITING

Hôpitaux Universitaires de Marseille Conception

Marseille, 13005, France

RECRUITING

CHRU de Nancy

Nancy, France

RECRUITING

Centre Hospitalier Universitaire De Nantes

Nantes, 44093, France

RECRUITING

Hôpital Lariboisiere

Paris, 75010, France

RECRUITING

CHU Cochin

Paris, France

NOT YET RECRUITING

CHU Toulouse

Toulouse, France

NOT YET RECRUITING

Centre Hospitalier Intercommunal

Créteil, Île-de-France Region, 94000, France

RECRUITING

MeSH Terms

Conditions

Sinusitis; Bronchiolitis Obliterans Syndrome

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Central Study Contacts

Emilie BEQUIGNON

CONTACT

0145175000; emilie.bequignon@chicreteil.fr

Camille JUNG

CONTACT

0145175000; camille.jung@chicreteil.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: December 15, 2021
• Study Start: November 21, 2022
• Primary Completion (Estimated): November 21, 2027
• Study Completion (Estimated): November 21, 2027
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (13)