An observational study in Chronic Rhinosinusitis With Nasal Polyps, sponsored by AstraZeneca. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by AstraZeneca · Observational
The CREW Study is a non-interventional prospective, observational study in patients with CRSwNP that will evaluate patient-reported outcomes and describe the proportion of participants achieving treatment goals.)
The study population will consist of male and female participants aged ≥ 18 years with diagnosed severe uncontrolled CRSwNP, for whom a tezepelumab biologic treatment for CRSWNP will be initiated. Eligible participant will be identified in routine care and enrolled prospectively at participating sites.
Exclusion Criteria:
Adult patients with severe CRSwNP who are newly initiated on subcutaneous (SC) tezepelumab. Eligible participants are those for whom therapy with systemic corticosteroids and/or surgery does not provide adequate disease control.
Drug: Tezepelumab
Subcutaneous (SC) tezepelumab indicated as add-on therapy for the treatment of participants with severe CRSwNP as part of routine clinical care.
Also known as: Tezspire
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
To describe the changes in participant-reported sinonasal symptoms as evaluated by sinonasal outcome test, 22 item (SNOT-22) total score.
Time frame: at 24 weeks from initiation of tezepelumab treatment.
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
To describe the changes in participant-reported sinonasal symptoms as SNOT-22 total score following initiation of tezepelumab treatment.
Time frame: at 4, 12, and 52 weeks from initiation of tezepelumab treatment
Proportion of tezepelumab SNOT-22 responders
Proportion of responders in sinonasal symptoms as evaluated by SNOT-22 total score, defined as patients achieving the MCID (≥ 8.9-point decrease from baseline) at each collected timepoint.
Time frame: up to 52 weeks
Odds to achieve tezepelumab SNOT-22 response
Odds to achieve tezepelumab SNOT-22 response meeting or exceeding the MCID (≥ 8.9-point decrease from baseline) at each collected timepoint.
Time frame: up to 52 weeks
Median time to first MCID-defined responder in sinonasal symptoms
To describe time to response in sinonasal symptoms as evaluated by SNOT-22 total score (time from baseline to the first occurrence of ≥ 8.9-point decrease).
Time frame: up to 52 weeks
Mean change from baseline in nasal blockage (NB) measured by VAS-NB
To describe changes in nasal blockage (NB) as evaluated by a visual analogue scale (VAS-NB) at each collected timepoint.
Time frame: up to 52 weeks
Proportion of NB responders
To describe proportion of NB responders, defined as patients achieving the MCID (≥ 3.0-point decrease from baseline; in participants with VAS-NB ≥ 7 at baseline) at each collected timepoint.
Time frame: up to 52 weeks
Median time to meeting or exceeding the MCID for VAS-NB
Median time from baseline to the first occurrence of a ≥3.0-point decrease by each collected timepoint in participants with VAS-NB ≥ 7 at baseline.
Time frame: up to 52 weeks
Mean change from baseline in sense of smell score by VAS-smell
To describe changes in sense of smell as evaluated by VAS-Smell
Time frame: up to 52 weeks
Proportion of VAS-Smell responders
Proportion of VAS-Smell responders, defined as patients achieving the MCID (≥ 3.0-point decrease from baseline) in participants with VAS-Smell ≥ 7 at baseline at each collected timepoint.
Time frame: up to 52 weeks
Median time to meeting or exceeding the MCID for VAS-Smell
Median time from baseline to the first occurrence of a ≥3.0-point decrease by each collected timepoint in participants with VAS-Smell ≥ 7 at baseline.
Time frame: up to 52 weeks
Mean change from baseline in NP severity as measured by VAS-NP symptoms
To describe changes in NP severity (VAS-NP) at each collected timepoint.
Time frame: up to 52 weeks
Proportion of VAS-NP symptom responders
To describe responders proportion of VAS-NP symptom responders, defined as patients achieving the MCID (≥ 2.5-point decrease from baseline) at each collected timepoint.
Time frame: up to 52 weeks
Median time to meeting or exceeding the MCID for VAS-NP symptom
Median time from baseline to the first occurrence of a ≥2.5-point decrease by each collected timepoint.
Time frame: up to 52 weeks
Mean change from baseline in total NPS evaluated by nasal endoscopy
To describe changes in nasal polyp score (NPS) at each collected timepoint.
Time frame: up to 52 weeks
Proportion of NPS responders
To describe proportion of NPS responders, defined as patients achieving the MCID (≥ 1.0-point decrease from baseline).
Time frame: up to 52 weeks
Median time to meeting or exceeding the MCID for NPS
To describe median time to meeting or exceeding the MCID for NPS by each collected timepoint.
Time frame: up to 52 weeks
Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question
To describe responder proportion for NP control.
Time frame: up to 52 weeks
Median time to first attainment of NP well control or NP complete control
To describe median time to first attainment of NP well control or NP complete control by each collected timepoint.
Time frame: up to 52 weeks
Average SCS daily dose after initiating tezepelumab
To describe overall systemic steroid use in participants, measured as average SCS daily dose (e.g., prednisone-equivalent milligrams).
Time frame: From baseline up to 24 weeks and from baseline up to 52 weeks
Proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use
To describe proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use.
Time frame: From baseline up to 24 weeks and from baseline up to 52 weeks
Number of patients with ≥ 100, 200 and 400 mg cumulative SCS
Number of patients with ≥ 100, 200 and 400 mg cumulative SCS (e.g., prednisone-equivalent milligrams).
Time frame: From baseline up to 24 weeks and from baseline up to 52 weeks
Time-to-first disease-related SCS use
Time-to-first disease-related SCS use, with cumulative incidence CRSwNP-related SCS use, asthma-related SCS use, other indications related SCS use and unknown indication-related SCS use.
Time frame: From baseline up to 24 weeks and from baseline up to 52 weeks
Proportion of participants with AEs, SAEs, DAEs, and AESIs
To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab.
Time frame: Up to 52 weeks
Individual goal attainment
Proportion of participants achieving symptoms goal: SNOT-22\* ≤ 20
Time frame: At Week 24 and Week 52
Individual goal attainment
Proportion of participants achieving Exacerbations goal: No SCS for sino-nasal exacerbations
Time frame: At Week 24 and Week 52
Individual goal attainment
Proportion of participants achieving Surgery goal: No sino-nasal surgery
Time frame: At Week 24 and Week 52
Individual goal attainment
Proportion of participants achieving Polyp burden goal: NPS improvement or NPS ≤2
Time frame: At Week 24 and Week 52
Individual goal attainment
Proportion of participants achieving olfaction goal: Smell PRO improvement following initiation of tezepelumab
Time frame: At Week 24 and Week 52
Composite goal attainment
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery
Time frame: At Week 24 and Week 52
Composite goal attainment
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/polyp
Time frame: At Week 24 and Week 52
Composite goal attainment
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/olfaction
Time frame: At Week 24 and Week 52
Composite goal attainment
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/polyp burden/olfaction
Time frame: At Week 24 and Week 52
No study locations are listed for this record.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. does not contain a plan to share individual participant data.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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