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NCT Number: NCT07780292

Effect of Post Operative Low Dose Oral Azithromycin in Chronic Rhinosinusitis Patients With Nasal Polyps

Chronic Rhinosinusitis with Nasal Polyps (CRSWNP) is a complex and persistent inflammatory disease of the paranasal sinus mucosa. It is clinically characterized by long-standing sinonasal mucosal inflammation, severe nasal congestion, continuous anterior and posterior rhinorrhea, facial pressure or fullness, and partial or complete loss of olfactory function. Functional Endoscopic Sinus Surgery (FESS) remains the primary surgical procedure of choice for CRSWNP cases that are refractory to conventional medical management. The ultimate goal of FESS is to restore surgical drainage pathways, improve sinus clearance, and re-establish proper sinus ventilation. This surgical intervention creates an anatomical environment optimal for post-operative topical medical therapies. Nevertheless, persistent mucosal inflammation, recalcitrant tissue edema, and post-operative recurrence of polypoid tissue represent major challenges during long-term follow-up. Despite initial surgical success, recurrent nasal polyposis remains a significant clinical challenge following Functional Endoscopic Sinus Surgery (FESS). In cases of recurrence, medical management plays a pivotal role in controlling mucosal inflammation and delaying or preventing re-operation. Diverse pharmacological interventions have been explored to control post-operative recurrence, including standard anti-inflammatory regimens as well as alternative systemic therapies such as some antibiotics, long-term macrolides, and novel biologics targeting specific inflammatory pathways. Macrolides, particularly 15-membered azalides such as Azithromycin, possess significant immunomodulatory and anti-inflammatory properties distinct from their classic antibacterial actions. When administered in low doses over extended periods, Azithromycin actively downregulates pro-inflammatory cytokines, inhibits tissue neutrophil infiltration, decreases goblet cell hypersecretion, and fosters mucosal healing and epithelial restoration.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Adult patients of both sexes aged ≥ 18 years.
  • Documented clinical and radiological diagnosis of Chronic Rhinosinusitis with Nasal Polyps (CRSWNP).
  • Patients with high baseline disease severity scores based on:
  • CT Paranasal Sinuses Staging: High Lund-Mackay CT Score.
  • Symptom Burden Assessment: High SNOT-22 Questionnaire Score. • Patients who comply with scheduled follow-up visits and appointments.

Exclusion criteria

  • • Patients aged under 18 years (< 18 years).
  • Presence of unilateral nasal polyps, antrochoanal polyps, granuloma / granulomatous lesions, fungal
  • rhinosinusitis, or suspected benign or malignant sinonasal neoplasms.
  • Development of significant drug-related adverse effects, adverse reactions, or clinical complications during the
  • treatment course.
  • Known hypersensitivity or previous severe allergic reactions to macrolide antibiotics.
  • Baseline prolonged QTc interval, active cardiac arrhythmias, or significant cardiovascular disease.
  • Pre-existing significant impairment of hepatic or renal functions.
  • Pregnant and lactating female patients.
  • Patients who fail to adhere to follow-up visits or refuse to sign the informed consent.

Treatment and study plan

Azithromycin

Drug

oral Azithromycin at a dose of 500 mg three times weekly

routine nasal douching

Procedure

alkaline/saline nasal irrigation three times daily) for a total duration of 12 weeks.

Primary outcomes

  1. recurrence rate of rhinosinusitis after low-dose oral azithromycin

    Time frame: 12 week

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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