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

NCT07316959 | Completed DMC

• 1 other identifier: 260/proposal-ENT/ERC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Keywords

macrolides; Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Change in symptom and disease severity scores

  (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

Study Arms (2)

Group A

EXPERIMENTAL

Received Macrolide (clarithromycin 250 mg) once day in addition to their usual prescription

Procedure: clarithromycin 250 mg

Group B

ACTIVE COMPARATOR

Patients in Group B received only their routine prescribed postoperative medications following surgery (no macrolide therapy).

Procedure: clarithromycin 250 mg

Interventions

clarithromycin 250 mg PROCEDURE

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.

Also known as: group B

Group A; Group B

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 15 to 75 years
• Clinical diagnosis of nasal polyps
• Underwent endoscopic sinus surgery

You may not qualify if:

• Current or recent use of antibiotics or macrolide therapy
• History of multiple facial fractures
• Presence of neurological disorders
• Presence of psychiatric or psychological disorders

Sponsors & Collaborators

• Fatima Jinnah Medical University: lead

Study Sites (1)

Muhammad Shouzib Sultan

Lahore, Punjab Province, 54780, Pakistan

Location

Related Publications (1)

• Yamada T, Fujieda S, Mori S, Yamamoto H, Saito H. Macrolide treatment decreased the size of nasal polyps and IL-8 levels in nasal lavage. Am J Rhinol. 2000 May-Jun;14(3):143-8. doi: 10.2500/105065800782102717.

  PMID: 10887619 RESULT

Related Links

• Related Info

MeSH Terms

Interventions

Clarithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 15, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)