Phase 4 Chronic Rhinosinusitis Trial, Recruiting NCT07268313 Sponsor: Rigshospitalet, Denmark Condition: Chronic Rhinosinusitis
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Phase 4 Chronic Rhinosinusitis Trial, Recruiting

NCT07268313
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older
  • You have chronic rhinosinusitis with nasal polyps (a long-term sinus condition where growths form inside the nose) and your polyps are present on both sides of the nose
  • You have previously had sinus surgery (with only rare exceptions)
  • When you first started your current medication, you met certain medical criteria showing signs of a specific type of inflammation, needed steroid tablets, had significant smell loss, had severe symptoms, or had asthma requiring a regular inhaler
  • You are currently being treated with either Dupilumab (300 mg) or Mepolizumab (100 mg), given every four weeks, and your dose has stayed the same for at least three months
  • Over the past year, all of your sinus symptoms (such as blocked nose, runny nose, facial pain, smell problems, sleep problems, or fatigue) have consistently been rated 5 or below on a scale of 0–10, meaning your condition has been well controlled
  • Over the past year, your nasal examination has shown very minimal or no polyp growth, and no thick mucus or swelling has been found
  • Over the past year, you have not needed sinus surgery or any rescue treatment (such as antibiotic or steroid tablets) for your sinus condition
  • You are able to understand Danish and are able to sign a consent form

Who may not be able to join:

  • You have had an acute flare-up of your sinus condition (not including a common cold) in the past twelve months
  • You have had polyps removed in an outpatient clinic within the last three months
  • Your asthma has been uncontrolled at any point in the past twelve months (confirm with trial site)
  • You are unable to understand written information or complete questionnaires due to a language barrier
  • You are currently receiving a different biological medication for any condition other than asthma
  • You are unable to give your own informed consent
  • The trial doctor decides for any reason that you are not suitable to participate
  • You are pregnant or are currently undergoing active IVF treatment
  • You have had or recently had a serious illness, such as cancer, that is expected to significantly affect your health or quality of life over the next two years
  • You are unwilling to follow the study procedures
  • You have had an allergic reaction to either Dupilumab or Mepolizumab

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: 60708594

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
3 April 2025
Est. completion
1 June 2027

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Number of patients who can continue being in complete remission being out of biologic treatment.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov