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

August 19, 2026 updated by: Kermina Ehab, Assiut University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
oral Azithromycin at a dose of 500 mg three times weekly
Procedure: routine nasal douching
alkaline/saline nasal irrigation three times daily) for a total duration of 12 weeks.
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
alkaline/saline nasal irrigation three times daily) for a total duration of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
recurrence rate of rhinosinusitis after low-dose oral azithromycin
Time Frame: 12 week
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • azithromycin in rhinosinusitis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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