Efficacy of Long-Term Low Dose Macrolide Therapy in Preventing Early Recurrence of Nasal Polyps After Endoscopic Sinus Surgery

January 3, 2026 updated by: Fatima Jinnah Medical University

Efficacy Of Long-Term Low Dose Macrolide Therapy In Preventing Early Recurrence Of Nasal Polyps After Endoscopic Sinus Surgery

This randomized controlled trial evaluated the effectiveness of long-term, low-dose clarithromycin (250 mg/day) in reducing symptoms, improving endoscopic and radiologic scores, and preventing early recurrence of nasal polyps after endoscopic sinus surgery. Conducted at the ENT Department of Sir Ganga Ram Hospital, Lahore, the study included patients aged 15-75 undergoing surgery for nasal polyps. Group A received clarithromycin for three months in addition to standard therapy, while Group B received standard therapy alone. Patients treated with clarithromycin showed significantly greater improvements in SNOT, Lund-Kennedy, and Lund-Mackay scores at 8 and 12 weeks compared to controls (p<0.05). Polyp recurrence at three months was also lower in the macrolide group (12%) than in the non-macrolide group (32%).

Overall, low-dose clarithromycin was found to be safe and effective in enhancing postoperative outcomes and reducing early recurrence of nasal polyps after endoscopic sinus surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54780
        • Muhammad Shouzib Sultan

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Male and female patients aged 15 to 75 years

Clinical diagnosis of nasal polyps

Underwent endoscopic sinus surgery

Willing and able to provide informed consent Exclusion Criteria

Current or recent use of antibiotics or macrolide therapy

History of multiple facial fractures

Presence of neurological disorders

Presence of psychiatric or psychological disorders

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Received Macrolide (clarithromycin 250 mg) once day in addition to their usual prescription
Procedure: clarithromycin 250 mg
Following surgery, patients were split into two groups at random . For three months, patients in group A received Macrolide (clarithromycin 250 mg) once day in addition to their usual prescription drugs.
Other Names:
  • group B
Active Comparator: Group B
Patients in Group B received only their routine prescribed postoperative medications following surgery (no macrolide therapy).
Procedure: clarithromycin 250 mg
Following surgery, patients were split into two groups at random . For three months, patients in group A received Macrolide (clarithromycin 250 mg) once day in addition to their usual prescription drugs.
Other Names:
  • group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in symptom and disease severity scores
Time Frame: 3 months
(Change in Sinonasal Outcome Test-22 (SNOT-22) , Lund-Kennedy score, and Lund-Mackay score) from baseline to 12 weeks after endoscopic sinus surgery.
3 months

Collaborators and Investigators

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

Sponsor

Fatima Jinnah Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

January 1, 2025

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

June 15, 2025

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Estimated)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 260/proposal-ENT/ERC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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