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Could a simple polyp removal plus a drug replace major sinus surgery?

NCT ID NCT07200336

Disease control Sponsor: Eye & ENT Hospital of Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two treatments for chronic sinusitis with nasal polyps: a less invasive surgery (simple polyp removal) combined with an anti-IL-5 drug (mepolizumab) versus extensive sinus surgery also with the drug. About 360 participants will be randomly assigned to one of three groups: drug alone, drug plus simple polyp removal, or drug plus extensive surgery. The goal is to see if the simpler approach works just as well, improving quality of life and nasal congestion over 1 to 3 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mepolizumab (anti-IL-5 drug)
What this could lead to
If successful, this could offer a less invasive treatment option for chronic sinusitis with nasal polyps, reducing the need for extensive surgery.
What could go wrong
This is a Phase 4 trial, but it's not yet recruiting. The less invasive approach may not be as effective as extensive surgery, and the drug may cause side effects like injection reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Endoscopy shows bilateral nasal polyps, with bilateral NPS ≥4 (≥2 per side) 2. Nasal obstruction symptoms \>3 months, nasal obstruction score ≥2 (total 3 points) and/or hyposmia ≥2 (maximum 3 points) 3. Evidence of type 2 inflammation: Nasal polyp tissue Eos \>55/HPF or \>27% of inflammatory cells; or Peripheral blood Eos ≥6.9% (without asthma) or ≥3.7% (with asthma) Note: Meet any 2 of the above 3 criteria 4. Failure after 4 weeks of standard medical therapy including: Intranasal corticosteroids \>4 weeks; Other agents (oral steroids, macrolides, antihistamines, leukotriene receptor antagonists, decongestants, antibiotics) permitted as needed Exclusion Criteria: 1. Cystic fibrosis, Young's syndrome, Kartagener syndrome, antrochoanal polyp, or rhinitis medicamentosa 2. Acute upper respiratory infection within 2 weeks 3. Asthma exacerbation within 1 month 4. HIV infection 5. Parasitic infection within 6 months 6. History of hypersensitivity to investigational drugs (except aspirin intolerance) 7. Hypersensitivity to monoclonal antibodies or anti-IL-5 agents 8. Oral steroid therapy within 1 month 9. Pregnancy planning, current pregnancy, or lactation 10. Uncontrolled systemic diseases 11. Have a history of previous sinus surgery for CRSwNP 12. Significant septal deviation affecting unilateral ventilation (mild deviation allowed) 13. Investigator judgment of unsuitability for cohort study

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Conditions

The condition(s) this trial relates to.

Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic rhinosinusitis with nasal polyps (CRSWNP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hangzhou First People's Hospital,School of Medicine, Westlake University

    Hangzhou, Zhejiang, 310006, China

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033, China

  • Eye & ENT Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200031, China

  • Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

    Shanghai, Shanghai Municipality, 200052, China

  • Longgang District Central Hospital of Shenzhen

    Shenzhen, Guangdong, 518000, China

  • Renmin hospital of Wuhan University

    Wuhan, Hubei, 430060, China

  • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200233, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000, China

  • The Affiliated Hospital of Yunnan University

    Kunming, Yunnan, 650000, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016, China

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005, China

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029, China

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000, China

  • The Second Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086, China

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001, China

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