Phase 3 Chronic Rhinosinusitis Trial, Terminated NCT04157335 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 (NCT04157335) enrolled 287 adults with chronic rhinosinusitis with nasal polyps — a condition where growths form inside the nose and sinuses, causing blockage and other symptoms. Participants were randomly assigned to receive either benralizumab (144 people) or a placebo (an inactive dummy treatment, 143 people) during a blinded phase lasting about 56 weeks, where neither participants nor their doctors knew who received which. The trial was primarily measuring two things: the size of nasal polyps as seen through a small camera (endoscopy), and how badly participants felt their nasal blockage was on a daily rating scale. The reported data shows that, at week 56, the polyp size score (rated 0–8, where higher means larger polyps) dropped by an average of 0.3 points in the benralizumab group and 0.1 points in the placebo group. For nasal blockage (rated 0–3, where higher means more severe), the average score fell by 0.64 points in the benralizumab group and 0.45 points in the placebo group. For the secondary measures, the reported data shows the smell difficulty score (0–3 scale) decreased by 0.26 versus 0.05; the sinus CT opacification score (0–24 scale) fell by 1.3 versus 0.7; and a broader quality-of-life score (0–110 scale) decreased by 18.0 versus 15.2 — all comparing benralizumab to placebo respectively. Regarding the time to a first nasal polyp surgery, the reported figures were approximately 6.3 months in the benralizumab group and 7.8 months in the placebo group, though what drove this difference is not explained in the submitted data. 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, Terminated

NCT04157335
Terminated Phase 3 🇦🇺 Australian site

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 a man or woman between 18 and 75 years old
  • You have been using a nasal corticosteroid spray regularly and consistently for at least 4 weeks before joining, and are willing to continue using it throughout the study
  • You have previously been treated with steroid tablets/injections or have had surgery for nasal polyps
  • You have nasal polyps in both nostrils, with a combined polyp score of at least 5 (and at least 2 in each nostril individually), as measured by a doctor
  • Your nasal polyp symptoms have been ongoing for at least 12 weeks before joining
  • You report moderate to severe nasal blockage (confirm with trial site for exact scoring details)
  • Your nasal blockage symptoms meet a certain level of severity over a two-week tracking period (confirm with trial site)
  • Your quality-of-life score related to your sinus and nasal symptoms reaches a certain level at two separate points in the study (confirm with trial site)
  • You have been diagnosed with asthma by a doctor
  • Your blood test shows a higher-than-normal level of a type of white blood cell called eosinophils
  • If you are of Asian background, your sinus scan results meet a specific threshold (confirm with trial site)

Who may not be able to join:

  • You have had nasal or sinus surgery within the last 3 months
  • You have certain nasal conditions that would make it difficult to properly assess the study's main goals, such as polyps on only one side of the nose, a severely deviated nasal septum blocking at least one nostril, overuse of nasal decongestant sprays, or a specific type of fungal sinus condition
  • You have other serious health conditions involving the same type of white blood cell (eosinophils) that could affect your safety or make the study results harder to interpret
  • You have taken steroid tablets or injections within 4 weeks before screening, or plan to take them during the study
  • You have received any biologic medication (a type of specialist drug) — whether approved or experimental — within the last 6 months
  • You are currently pregnant or breastfeeding

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.

Contact this trial

Principal Investigator: Luo Zhang, Prof. Dr., Beijing Tongren Hospital

Australian sites

Research Site, Herston,
Research Site, Melbourne,
Research Site, Spearwood,

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

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Terminated
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
25 November 2019
Est. completion
6 August 2024

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇱 Chile 🇨🇳 China 🇫🇷 France 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇷🇺 Russia 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇺🇸 United States 🇻🇳 Vietnam

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change From Baseline in Endoscopic Total Nasal Polyp Score (NPS) at Week 56; Change From Baseline in Mean Nasal Blockage Score (NBS) at Week 56.

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