EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

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.

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.)

Tezepelumab CRSwNP Real World study (CREW Study)

Therapeutic Area

NCT ID

Patient Level Data

CTIS Number

EudraCT Number

Subcutaneous (SC) tezepelumab indicated as add-on therapy for the treatment of participants with severe CRSwNP as part of routine clinical care.

Research Site

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.

To describe the changes in participant-reported sinonasal symptoms as evaluated by sinonasal outcome test, 22 item (SNOT-22) total score.

To describe the changes in participant-reported sinonasal symptoms as SNOT-22 total score following initiation of tezepelumab treatment.

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.

Odds to achieve tezepelumab SNOT-22 response meeting or exceeding the MCID (≥ 8.9-point decrease from baseline) at each collected timepoint.

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).

To describe changes in nasal blockage (NB) as evaluated by a visual analogue scale (VAS-NB) at each collected timepoint.

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.

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.

To describe changes in sense of smell as evaluated by VAS-Smell

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.

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.

To describe changes in NP severity (VAS-NP) at each collected timepoint.

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.

Median time from baseline to the first occurrence of a ≥2.5-point decrease by each collected timepoint.

To describe changes in nasal polyp score (NPS) at each collected timepoint.

To describe  proportion of NPS responders, defined as patients achieving the MCID (≥ 1.0-point decrease from baseline).

To describe median time to meeting or exceeding the MCID for NPS by each collected timepoint.

To describe responder proportion for NP control.

To describe median time to first attainment of NP well control or NP complete control by each collected timepoint.

To describe overall systemic steroid use in participants, measured as average SCS daily dose (e.g., prednisone-equivalent milligrams).

To describe proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use.

Number of patients with ≥ 100, 200 and 400 mg cumulative SCS (e.g., prednisone-equivalent milligrams).

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.

To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab.

Proportion of participants achieving symptoms goal: SNOT‑22* ≤ 20

Proportion of participants achieving Exacerbations goal: No SCS for sino‑nasal exacerbations

Proportion of participants achieving Surgery goal: No sino‑nasal surgery

Proportion of participants achieving Polyp burden goal:  NPS improvement or NPS ≤2

Proportion of participants achieving olfaction goal:  Smell PRO improvement following initiation of 
tezepelumab

Proportion of participants achieving the 
following goals combinations: Combined symptom/exacerbation/surgery

Proportion of participants achieving the 
following goals combinations: Combined symptom/exacerbation/surgery/polyp

Proportion of participants achieving the 
following goals combinations: Combined symptom/exacerbation/surgery/olfaction

Proportion of participants achieving the following goals combinations: Combined symptom/exacerbation/surgery/polyp burden/olfaction

Tezepelumab CRSwNP Real World study (CREW Study) - CREW

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

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Estimated Enrollment

Study type

Age

Date

Study design

Verification:

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