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Not yet recruitingNCT07780292Updated Aug 21, 2026

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

A Phase 4 interventional study of Azithromycin and routine nasal douching in Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Assiut University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • Active comparator
    Study Group

    Patients will receive post-operative oral Azithromycin at a dose of 500 mg three times weekly in combination with routine nasal douching (alkaline/saline nasal irrigation three times daily) for a total duration of 12 weeks.

    Drug: Azithromycin · Procedure: routine nasal douching

  • Placebo comparator
    Control Group

    Patients will be treated with routine nasal douching alone (alkaline/saline nasal irrigation three times daily) for a total duration of 12 weeks.

    Procedure: routine nasal douching

Interventions

  • DrugAzithromycin

    oral Azithromycin at a dose of 500 mg three times weekly

  • Procedureroutine nasal douching

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

05

What researchers measure

Primary outcomes

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

    Time frame: 12 week

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07780292
Lead sponsor
Assiut University
Responsible party
Kermina Ehab (residant doctor at Assiut university hospital, Assiut University) — Principal investigator
First posted
Aug 21, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 21, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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