Chronic Rhinosinusitis With Nasal PolypsCREWNCT07790198
Tezepelumab CRSwNP Real World Study (CREW Study)
An observational study of Chronic Rhinosinusitis With Nasal Polyps, run by AstraZeneca.
Trial summary
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.) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Tezepelumab
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 28 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Participant must be 18 years of age or older, at the time of signing the informed consent
- Confirmed diagnosis of CRSwNP for at least 12 months prior to routine care visit 1
- Participants who will be enrolled after index date need to have at least SNOT-22 prior (maximum of 4 weeks) to index date
- Documented SNOT-22 total score>=30, collected within the 4 weeks prior to the first tezepelumab dose (index date)
- Treated per the Japanese Handbook for the Management of Chronic Rhinosinusitis with Nasal Polyps for at least 30 days prior to routine care visit 1
- Physician decision that participant is eligible for treatment with tezepelumab according to local approved CRSwNP label and Optimal Clinical Use Guidelines
- Patients must be able and willing to read and comprehend written instructions, to collect PROs and medication intake and to sign the informed consent document
Who cannot join
- Patients who participate in an interventional clinical trial in the last 4 months
- Known hypersensitivity to tezepelumab or any of its excipients
- Patients who have received any biologic therapy for asthma or CRSwNP
- Condition (acute or chronic) that, in the investigator's opinion, would limit the participant´s ability to complete questionnaires or participate in this study
- Pregnancy or lactation period or planning pregnancy during the study period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
Official title: Tezepelumab CRSwNP Real World Study (CREW Study): Non-interventional Prospective, Observational Study in Patients With CRSwNP Treated by Tezepelumab, Evaluating Patient-reported Outcomes in Japan Real World Practice.
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.)
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Tezepelumab
- Keywords
- Tezepelumab, Chronic rhinosinusitis with nasal polyps, CRSwNP, Observational Study, Patient-Reported Outcomes, Japan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TezepelumabDrug
Also called Tezspire
Subcutaneous (SC) tezepelumab indicated as add-on therapy for the treatment of participants with severe CRSwNP as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Tezepelumab Treatment Group | 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. Receives: Drug: Tezepelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 24 weeks from initiation of tezepelumab treatment.
Secondary outcomes (32)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 52 weeks
Individual goal attainment
Proportion of participants achieving symptoms goal: SNOT-22* ≤ 20
Measured: At Week 24 and Week 52
Individual goal attainment
Proportion of participants achieving Exacerbations goal: No SCS for sino-nasal exacerbations
Measured: At Week 24 and Week 52
Individual goal attainment
Proportion of participants achieving Surgery goal: No sino-nasal surgery
Measured: At Week 24 and Week 52
Individual goal attainment
Proportion of participants achieving Polyp burden goal: NPS improvement or NPS ≤2
Measured: At Week 24 and Week 52
Individual goal attainment
Proportion of participants achieving olfaction goal: Smell PRO improvement following initiation of tezepelumab
Measured: At Week 24 and Week 52
Composite goal attainment
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery
Measured: At Week 24 and Week 52
Composite goal attainment
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/polyp
Measured: At Week 24 and Week 52
Composite goal attainment
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/olfaction
Measured: At Week 24 and Week 52
Composite goal attainment
Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/polyp burden/olfaction
Measured: At Week 24 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion28 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790198
- Sponsor's protocol ID
- D5242R00014
- Acronym
- CREW
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tezepelumab CRSwNP Real World Study (CREW Study): Non-interventional Prospective, Observational Study in Patients With CRSwNP Treated by Tezepelumab, Evaluating Patient-reported Outcomes in Japan Real World Practice.
- ClinicalTrials.gov ID
- NCT07790198
- Acronym / sponsor ID
- CREW / D5242R00014
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Keywords
- Tezepelumab, Chronic rhinosinusitis with nasal polyps, CRSwNP, Observational Study, Patient-Reported Outcomes, Japan
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 28 Sep 2029 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tezepelumab Treatment Group | – | Drug: TezepelumabAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- Participant must be 18 years of age or older, at the time of signing the informed consent
- Confirmed diagnosis of CRSwNP for at least 12 months prior to routine care visit 1
- Participants who will be enrolled after index date need to have at least SNOT-22 prior (maximum of 4 weeks) to index date
- Documented SNOT-22 total score>=30, collected within the 4 weeks prior to the first tezepelumab dose (index date)
- Treated per the Japanese Handbook for the Management of Chronic Rhinosinusitis with Nasal Polyps for at least 30 days prior to routine care visit 1
Key exclusion criteria (5 listed)
- Patients who participate in an interventional clinical trial in the last 4 months
- Known hypersensitivity to tezepelumab or any of its excipients
- Patients who have received any biologic therapy for asthma or CRSwNP
- Condition (acute or chronic) that, in the investigator's opinion, would limit the participant´s ability to complete questionnaires or participate in this study
- Pregnancy or lactation period or planning pregnancy during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TezepelumabAlso: TezspireSubcutaneous (SC) tezepelumab indicated as add-on therapy for the treatment of participants with severe CRSwNP as part of routine clinical care. | Drug | Tezepelumab Treatment Group |
Primary outcome
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
Time frame: at 24 weeks from initiation of tezepelumab treatment.
To describe the changes in participant-reported sinonasal symptoms as evaluated by sinonasal outcome test, 22 item (SNOT-22) total score.
32 secondary outcomes
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score
Time frame: at 4, 12, and 52 weeks from initiation of tezepelumab treatment
Proportion of tezepelumab SNOT-22 responders
Time frame: up to 52 weeks
Odds to achieve tezepelumab SNOT-22 response
Time frame: up to 52 weeks
Median time to first MCID-defined responder in sinonasal symptoms
Time frame: up to 52 weeks
Mean change from baseline in nasal blockage (NB) measured by VAS-NB
Time frame: up to 52 weeks
Proportion of NB responders
Time frame: up to 52 weeks
Median time to meeting or exceeding the MCID for VAS-NB
Time frame: up to 52 weeks
Mean change from baseline in sense of smell score by VAS-smell
Time frame: up to 52 weeks
Proportion of VAS-Smell responders
Time frame: up to 52 weeks
Median time to meeting or exceeding the MCID for VAS-Smell
Time frame: up to 52 weeks
Mean change from baseline in NP severity as measured by VAS-NP symptoms
Time frame: up to 52 weeks
Proportion of VAS-NP symptom responders
Time frame: up to 52 weeks
Median time to meeting or exceeding the MCID for VAS-NP symptom
Time frame: up to 52 weeks
Mean change from baseline in total NPS evaluated by nasal endoscopy
Time frame: up to 52 weeks
Proportion of NPS responders
Time frame: up to 52 weeks
Median time to meeting or exceeding the MCID for NPS
Time frame: up to 52 weeks
Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question
Time frame: up to 52 weeks
Median time to first attainment of NP well control or NP complete control
Time frame: up to 52 weeks
Average SCS daily dose after initiating tezepelumab
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
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
Time frame: From baseline up to 24 weeks and from baseline up to 52 weeks
Time-to-first disease-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
Time frame: Up to 52 weeks
Individual goal attainment
Time frame: At Week 24 and Week 52
Individual goal attainment
Time frame: At Week 24 and Week 52
Individual goal attainment
Time frame: At Week 24 and Week 52
Individual goal attainment
Time frame: At Week 24 and Week 52
Individual goal attainment
Time frame: At Week 24 and Week 52
Composite goal attainment
Time frame: At Week 24 and Week 52
Composite goal attainment
Time frame: At Week 24 and Week 52
Composite goal attainment
Time frame: At Week 24 and Week 52
Composite goal attainment
Time frame: At Week 24 and Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis With Nasal Polyps, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score (time frame: at 24 weeks from initiation of tezepelumab treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.