Phase 3 Chronic Rhinosinusitis Trial, Completed NCT04851964 Sponsor: AstraZeneca Condition: Chronic Rhinosinusitis
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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial (NCT04851964) looked at a medicine called tezepelumab in people with nasal polyps (growths inside the nose that can cause blockage and other symptoms). A total of 203 people received tezepelumab and 205 received a placebo (a dummy treatment with no active ingredient) over 52 weeks. The trial was primarily measuring changes in the size of nasal polyps (using an endoscopy score out of 8) and changes in how blocked participants' noses felt day-to-day. The reported data shows that, after 52 weeks, the nasal polyp score in the tezepelumab group fell by an average of 2.46 points, compared with a fall of 0.38 points in the placebo group (both starting from the same baseline). For nasal congestion — rated by participants on a 0–3 scale — the tezepelumab group reported an average drop of 1.74 points, versus 0.70 points in the placebo group. The reported data also shows changes in several secondary measures: difficulty with sense of smell fell by 1.26 points (tezepelumab) versus 0.26 points (placebo) on a 0–3 scale; a quality-of-life questionnaire score (SNOT-22, rated 0–110) fell by 45.0 points versus 17.6 points; a CT scan-based sinus score (0–24) fell by 6.27 points versus 0.57 points. Regarding the need for surgery or steroid rescue treatment, 5.7% of participants in the tezepelumab group reached that point compared with 31.4% in the placebo group. These figures reflect the numbers submitted to the registry; the study did not report any missing outcome data for the measures listed above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Chronic Rhinosinusitis Trial, Completed

NCT04851964
Completed Phase 3

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 have been diagnosed by a doctor with chronic rhinosinusitis with nasal polyps (growths inside the nose) for at least 12 months before the first visit, and your polyps are severe enough that surgery has been considered
  • You have significant nasal congestion and have had ongoing nasal symptoms (such as a runny nose and/or loss of smell) for more than 8 weeks before screening
  • Your quality-of-life impact from your nasal polyp symptoms scores at a certain level on a standard questionnaire (confirm with trial site)
  • You are on any standard treatment for nasal polyps and have been stable on that treatment for at least 30 days before your first visit
  • In the past 12 months (but not in the last 3 months), you have been treated with steroid tablets/injections for a nasal polyp flare-up for at least 3 days, OR you have previously had nasal polyp surgery — or you were unable to have these treatments due to medical reasons

Who may not be able to join:

  • You have significant lung or breathing conditions other than asthma (such as active lung infection, cystic fibrosis, or pulmonary fibrosis) that could affect the trial results
  • You have had sinus surgery in the last 6 months, or previous sinus surgery that significantly altered the inside structure of your nose making assessment of polyps impossible
  • You tested positive for COVID-19 at the screening visit, or your COVID-19 screening questionnaire raised concerns
  • You regularly use nasal or oral decongestant medications (except when used for a medical procedure)
  • You have used immune-suppressing medications (such as methotrexate, cyclosporine, or steroid tablets/injections) within 3 months before joining or plan to use them during the study
  • You received a COVID-19 vaccine within 28 days before your scheduled treatment start date

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 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
22 April 2021
Est. completion
23 September 2024

Where this trial is recruiting

🇨🇦 Canada 🇨🇳 China 🇩🇰 Denmark 🇩🇪 Germany 🇭🇺 Hungary 🇯🇵 Japan 🇵🇱 Poland 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Change From Baseline in Total Nasal Polyp Score at Week 52; Change From Baseline in Bi-weekly Mean Nasal Congestion Score (NCS) at Week 52

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