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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-06-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Rhinosinusitis With Nasal Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

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

Group Type EXPERIMENTAL

clarithromycin 250 mg

Intervention Type 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.

Group B

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

Group Type ACTIVE_COMPARATOR

clarithromycin 250 mg

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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group B

Eligibility Criteria

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Inclusion Criteria

Male and female patients aged 15 to 75 years

Clinical diagnosis of nasal polyps

Underwent endoscopic sinus surgery

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

Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No