Chronic Rhinosinusitis With Nasal PolypsNCT07316959
Efficacy of Long-Term Low Dose Macrolide Therapy in Preventing Early Recurrence of Nasal Polyps After Endoscopic Sinus Surgery
A study testing clarithromycin 250 mg in people with Chronic Rhinosinusitis With Nasal Polyps, run by Fatima Jinnah Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- clarithromycin 250 mg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- clarithromycin 250 mg
- Keywords
- macrolides, Chronic Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clarithromycin 250 mgProcedure or surgery
Also called group B
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Received Macrolide (clarithromycin 250 mg) once day in addition to their usual prescription Receives: Procedure: clarithromycin 250 mg |
| Group B | Active comparator | Patients in Group B received only their routine prescribed postoperative medications following surgery (no macrolide therapy). Receives: Procedure: clarithromycin 250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Jan 2025
- Primary completion1 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316959
- Sponsor's protocol ID
- 260/proposal-ENT/ERC
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10887619
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Long-Term Low Dose Macrolide Therapy In Preventing Early Recurrence Of Nasal Polyps After Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT07316959
- Acronym / sponsor ID
- 260/proposal-ENT/ERC
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Keywords
- macrolides, Chronic Rhinosinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fatima Jinnah Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: clarithromycin 250 mgReceived Macrolide (clarithromycin 250 mg) once day in addition to their usual prescription |
| Group B | Active comparator | Procedure: clarithromycin 250 mgPatients in Group B received only their routine prescribed postoperative medications following surgery (no macrolide therapy). |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clarithromycin 250 mgAlso: group BFollowing 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. | Procedure or surgery | Group A, Group B |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Results publication: PubMed 10887619Yamada 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clarithromycin 250 mg in people with Chronic Rhinosinusitis With Nasal Polyps, run by Fatima Jinnah Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptom and disease severity scores (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07316959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.