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Een studie naar het klinische resultaat en de kwaliteit van leven bij Chinese postoperatieve CRSwNP-patiënten (PREDICT)

22 september 2026 bijgewerkt door: AstraZeneca

PREDICT: A Prospective, Multicenter Real-World Study to Describe the Clinical Outcome and Quality of Life in Chinese Post-operative CRSwNP Patients

This is a prospective, multicenter real-world observational study designed to describe post-operative outcomes, quality of life, disease control, recurrence-related characteristics, economic burden and post-operative treatment patterns in Chinese patients with CRSwNP undergoing endoscopic sinus surgery (ESS).

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a prospective, multicenter real-world observational study designed to describe post-operative outcomes, quality of life, disease control, recurrence-related characteristics, economic burden and post-operative treatment patterns in Chinese patients with CRSwNP undergoing endoscopic sinus surgery (ESS). Patients will receive standard medical care as determined by the treating physician at each site and, where possible, undergo scheduled study assessments that coincide with routine follow-up.

Approximately 200 patients diagnosed with CRSwNP by physicians and scheduled for surgical treatment will be enrolled from ~20 sites across different regions of China.

Potential participants will be identified during a screening period of up to 4 weeks before surgery. Participants who meet the eligibility criteria, provide informed consent, and undergo ESS during the screening period will be enrolled.

After enrolment, participants will undergo 52 weeks of post-operative follow-up. Planned follow-up timepoints are week 4 (Visit 2), week 12 (Visit 3), week 24 (Visit 4), week 36 (Visit 5), and week 52 (Visit 6). Follow-up data will be obtained from medical records, routine clinical assessments, and participant-reported questionnaires.

Studietype

Observationeel

Inschrijving (Werkelijk)

146

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • China
      • Changchun, China, 130033
        • Research Site
      • Changsha, China
        • Research Site
      • Chengdu, China, 610078
        • Research Site
      • Guangzhou, China
        • Research Site
      • Guangzhou, China, 510062
        • Research Site
      • Guangzhou, China, 514700
        • Research Site
      • Haikou, China, 570311
        • Research Site
      • Kunming, China
        • Research Site
      • Nanchang, China
        • Research Site
      • Nanjing, China
        • Research Site
      • Nanning, China, 530021
        • Research Site
      • Qingdao, China
        • Research Site
      • Shanghai, China, 200031
        • Research Site
      • Shenzhen, China
        • Research Site
      • Wuhan, China
        • Research Site
      • Wuhan, China, 430000
        • Research Site
      • Xiamen, China, 361003
        • Research Site
      • Ürümqi, China, 830054
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China, 518106
        • The Seventh Affiliated Hospital Sun Yat-sen University
    • Liaoning
      • Shenyang, Liaoning, China, 110002
        • Shengjing Hospital of China Medical University
    • Shandong
      • Jinan, Shandong, China, 250012
        • QiLu Hospital of Shandong University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Chinese CRSwNP Patients

Beschrijving

Inclusion Criteria:

  1. Participant must be 16 years of age or older, at the time of signing the informed consent.
  2. Participants with a documented diagnosis of bilateral CRSwNP.
  3. ESS is performed during the screening period.
  4. Voluntarily participate and sign the ICF.
  5. No history or current psychiatric disorders, with normal cognitive functions including understanding, expression, and orientation.

Exclusion Criteria:

  1. Any significant disease or disorder that the investigator believes may place the patient at risk or may affect the study results or the patient's ability to participate in the study.
  2. Use of biologic therapy for CRSwNP within 3 months prior to surgery.
  3. Currently participating in an interventional study.
  4. Patients who are unable to independently complete questionnaires due to language barriers or mental status.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: OTHER
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
CRSwNP Registry Cohort

This is a prospective, multicenter real-world observational study .Patients will receive standard medical care as determined by the treating physician according to routine clinical practice at each site. No treatment assignment will be made as part of the study.
Ander: Other: Routine Clinical Care for CRSwNP

Patients will receive standard medical care as determined by the treating physician according to routine clinical practice at each site. No treatment assignment will be made as part of the study.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The observed value and change from baseline in SNOT-22 total score at week-52
Tijdsspanne: baseline-week52

To describe the Sino-Nasal Outcome Test (SNOT)-22 total score at 52 weeks post- operatively.

[SNOT-22: score 0-5 each item, 5 means worse outcome, 22 items totally]
baseline-week52
The observed value and change from baseline in MLK score at week-52
Tijdsspanne: baseline-week52

To describe the Modified Lund-Kennedy (MLK) score at 52 weeks post-operatively. [MLK score: score 0-24, 24 means worse outcome]
baseline-week52

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The observed values and changes from baseline at each collection point: VAS - Total sinus symptoms item
Tijdsspanne: baseline-week52

To describe the changes in post-operative symptom by Visual Analogue Scale(VAS) total sinus symptoms .

[VAS: score 0-10, 10 indicates worse outcome]
baseline-week52
The observed values and changes from baseline in NPS at each collection point
Tijdsspanne: baseline-week52

To describe the changes in post-operative by Nasal Polyp Score (NPS). [NPS: score 0-4, 4 indicates worse outcome]
baseline-week52
The observed values and changes from baseline at each collection point: VAS - Nasal blockage item
Tijdsspanne: baseline-week52

To describe the changes in post-operative symptom by Visual Analogue Scale(VAS) Nasal blockage item .

[VAS: score 0-10, 10 indicates worse outcome]
baseline-week52
The observed values and changes from baseline at each collection point: SNOT-22 Smell/taste Item Score
Tijdsspanne: baseline-week52

To describe the changes in post-operative symptom by Sinonasal outcome test-22(SNOT-22) Smell/taste Item Score.

[SNOT-22: score 0-5 for each item, 5 means worse outcome]
baseline-week52
The observed values and changes from baseline at each collection point: SNOT-22 Nasal Congestion Item Score
Tijdsspanne: baseline-week52

To describe the changes in post-operative symptom by Sinonasal outcome test-22(SNOT-22) Nasal Congestion Item Score.

[SNOT-22: score 0-5 for each item, 5 means worse outcome]
baseline-week52
The observed values and changes from baseline at each collection point: Nasal Congestion Score (NCS)
Tijdsspanne: baseline-week52

To describe the changes in post-operative symptom by Nasal Congestion Score(NCS).

[NCS: score 0-3, 3 indicates worse outcome]
baseline-week52
The observed values and changes from baseline at each collection point: Loss of Smell
Tijdsspanne: baseline-week52

To describe the changes in post-operative symptom by Loss of Smell Item Score. [ Loss of Smell : score 0-3 for each item, 3 means worse outcome]
baseline-week52
The observed values and changes from baseline at each collection point: Nasal Airway Resistance (NAR)
Tijdsspanne: baseline-week52

To describe the changes in post-operative symptom by Nasal Airway Resistance(NAR).
baseline-week52
Pre-operative, 24-week post-operatively, and 52- week post-operative Lund-Mackay CT Scores.
Tijdsspanne: week0-52

To describe the changes in post-operative CT Scores
week0-52
The observed values and cChanges from baseline at each collection point: SF-36((Short Form Health Survey)
Tijdsspanne: baseline-week52

To describe the changes in post-operative Quality of Life by SF-36((Short Form Health Survey), which is a widely used questionnaire to measure health-related quality of life.
baseline-week52
The observed values and changes from baseline at each collection point: The SNOT-22 top five items' frequency counts and average score
Tijdsspanne: baseline-week52

To describe the changes in post-operative Quality of Life by Sinonasal outcome test-22(SNOT-22) top five items' frequency counts and average score.

[SNOT-22: score 0-5 for each item, 5 means worse outcome]
baseline-week52
The observed values and changes from baseline at each collection point: SNOT-22 sleep domain
Tijdsspanne: baseline-week52

To describe the changes in post-operative Sleep Quality [SNOT-22: score 0-5 for each item, 5 means worse outcome]
baseline-week52
Intranasal corticosteroids (INCS): the proportion of participants using INCS.
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by the proportion of participants using Intranasal corticosteroids (INCS).
week0-52
The daily dosage of participants used Systemic glucocorticoids (SCSs) for CRSwNP
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by：

• The daily dosage (convert according to the equivalent dose of prednisone.) of participants used Systemic glucocorticoids (SCSs) for CRSwNP
week0-52
Proportion of participants who used Antibiotics for CRSwNP at least once
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by:

• Proportion of participants who used Antibiotics for CRSwNP at least once.
week0-52
Proportion of participants who used biologics for CRSwNP at least once
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by:

• Proportion of participants who used at least once.
week0-52
Proportion of participants who used ICS/LABA for asthma at least once.
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by

• Proportion of participants who used at least once.
week0-52
Proportion of other related medications used.
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively.
week0-52
The proportion of participants requiring surgery within one year and the number of surgery
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively.
week0-52
Time to first recurrence
Tijdsspanne: week0-52

To describe the time to first recurrence and proportion of participants with recurrence
week0-52
Proportion of participants with recurrence
Tijdsspanne: week0-52

To describe the time to first recurrence and proportion of participants with recurrence
week0-52
Proportion of participants demonstrating clinically meaningful improvement at Week 52 and Week 4 postoperatively based on: -NCS (MCID relative to pre-operative of -1.0)
Tijdsspanne: week0-52

To describe the proportion of post-operative participants demonstrating clinically meaningful improvement at Week-52 and Week-4
week0-52
Proportion of participants demonstrating clinically meaningful improvement at Week 52 and Week 4 postoperatively based on: - SNOT-22 total score (with a Minimum Clinically Important Difference (MCID) relative to pre-operative of -8.9)
Tijdsspanne: week0-52

To describe the proportion of post-operative participants demonstrating clinically meaningful improvement at Week-52 and Week-4 [SNOT-22: score 0-5 for each item, 5 means worse outcome]
week0-52
Proportion of participants demonstrating clinically meaningful improvement at Week 52 and Week 4 postoperatively based on: - VAS for nasal blockage item (MCID relative to pre-operative of -3)
Tijdsspanne: week0-52

To describe the proportion of post-operative participants demonstrating clinically meaningful improvement at Week-52 and Week-4 [VAS scale: 0-10,10 means worse outcome]
week0-52
The proportion of participants with post-operative complications
Tijdsspanne: week0-52

Post-operative complications by

•The proportion of participants with complications.
week0-52
Changes from baseline at each collection point: Spirometry (pre-BD FEV1)
Tijdsspanne: baseline-week52

To describe asthma-related outcomes (for asthma participants only)
baseline-week52
Changes from baseline at each collection point: Asthma Control Questionnaire-5(ACQ-5)
Tijdsspanne: baseline-week52

To describe asthma-related outcomes (for asthma participants only) [ACQ-5: score 0-6 for each item, 6 means worse outcome]
baseline-week52
Pre-operative, 24-week post-operatively, and 52-week ethmoid/maxillary sinuses (E/M) ratio
Tijdsspanne: week0-52

To describe the changes in post-operative ethmoid/maxillary sinuses (E/M) ratio.
week0-52
Pre-operative, 24-week post-operatively, and 52-week Olfactory Cleft Scores(NCS)
Tijdsspanne: week0-52

To describe the changes in post-operative Olfactory Cleft Scores(NCS). [NCS: score 0-3, 3 means worse outcome]
week0-52
The number of days of use intranasal corticosteroids (INCS).
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by the number of days of use intranasal corticosteroids (INCS).
week0-52
The proportion of participants who used Systemic glucocorticoids (SCSs) for CRSwNP
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by：

• Proportion of participants who used Systemic glucocorticoids (SCSs) for CRSwNP at least once.
week0-52
Number of days of treatment with Systemic glucocorticoids (SCSs) for CRSwNP.
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by：

• The number of use days that participants used Systemic glucocorticoids (SCSs) for CRSwNP.
week0-52
The proportion of participants who used Systemic glucocorticoids (SCSs) for asthma
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by：

• Proportion of participants who used Systemic glucocorticoids (SCSs) for asthma at least once.
week0-52
The daily dosage of participants used Systemic glucocorticoids (SCSs) for asthma
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by：

• The daily dosage (convert according to the equivalent dose of prednisone.) of participants used Systemic glucocorticoids (SCSs) for asthma
week0-52
Number of days of treatment with Systemic glucocorticoids (SCSs) for asthma.
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by：

• The number of use days that participants used Systemic glucocorticoids (SCSs) for asthma.
week0-52
Number of days of treatment with Antibiotics for CRSwNP
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by:

• The number of use days.
week0-52
Proportion of participants who used Antibiotics for asthma at least once
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by:

• Proportion of participants who used Antibiotics for asthma at least once.
week0-52
Number of days of treatment with Antibiotics for asthma
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by:

• The number of use days.
week0-52
Number of days of treatment with ICS/LABA for asthma
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by

• The number of use days.
week0-52
Proportion of participants who used ICS/LABA/LAMA for asthma at least once.
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by

• Proportion of participants who used at least once.
week0-52
Number of days of treatment with ICS/LABA/LAMA for asthma
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by

• The number of use days.
week0-52
The types of post-operative complications
Tijdsspanne: week0-52

Post-operative complications by

•The types of post-operative complications.
week0-52
The number of post-operative complications occurrences.
Tijdsspanne: week0-52

Post-operative complications by

•The number of complication occurrences.
week0-52
Proportion of participants who used biologics for asthma
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by:

• Proportion of participants who used at least once.
week0-52
The frequency of use biologics for CRSwNP
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by:

• The frequency of use.
week0-52
The frequency of use biologics for asthma
Tijdsspanne: week0-52

To describe the post-operative medication use and need for surgery within one year post-operatively by:

• The frequency of use.
week0-52

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
T2：bEOS≥150 cells/μL or Tissue EOS≥10/hpf or Total IgE≥100 IU/ml.
Tijdsspanne: Baseline

Proportion of different inflammatory subtype at baseline.
Baseline
bEOS: <150，150-300，≥300 cells/μL.
Tijdsspanne: Baseline

Proportion of different inflammatory subtype at baseline.
Baseline
Tissue EOS≥10/hpf.
Tijdsspanne: Baseline

Proportion of different inflammatory subtype at baseline.
Baseline
Total IgE≥100 IU/ml.
Tijdsspanne: Baseline

Proportion of different inflammatory subtype at baseline.
Baseline
Baseline characteristics of patients with recurrence.
Tijdsspanne: Baseline

Explore the characteristics/markers of recurrence within 1 year post-operate: such as gender, age, comorbidities (allergic rhinitis, asthma, NSAID-exacerbated respiratory disease, dermatitis/eczema, COPD, somnipathy etc.), phenotype, pre-operative scores, tissues (eosinophils (count: n/HPF; percentage: %), neutrophils (n/HPF; %) IL-4, IL-5, IL-13, IL-33, IL-17, TNF-α, IFN-γ,IL-25, TGF-β and TSLP ), serum (total IgE and specific IgE (IU/mL), ECP), blood (eosinophils (count: 10^9/L; percentage: %), basophils (10^9/L; %), neutrophils (10^9/L; %), monocytes (10^9/L; %), lymphocytes (10^9/L; %)) and S. aureus abundance
Baseline
Differences in characteristics between patients with clinically meaningful improvement and those without at week-52 and week-4 after surgery.
Tijdsspanne: week-52, week-4

Explore the baseline characteristics and biomarkers related to surgical prognosis of patients:such as gender, age, comorbidities, phenotype, pre- operative scores, S. aureus abundance, different markers in nasal secretions, blood, and tissues
week-52, week-4
Number of participants with AEs, ADRs, and special situations associated with identified AstraZeneca products used for CRSwNP and/or asthma treatment if any.
Tijdsspanne: baseline-week52

To summarize adverse events (AEs), adverse drug reactions (ADRs), and special situations associated with identified AstraZeneca products used for CRSwNP and/or asthma treatment, if any.
baseline-week52
Proportion of participants with AEs, ADRs, and special situations associated with identified AstraZeneca products used for CRSwNP and/or asthma treatment if any.
Tijdsspanne: baseline-week52

To summarize adverse events (AEs), adverse drug reactions (ADRs), and special situations associated with identified AstraZeneca products used for CRSwNP and/or asthma treatment, if any.
baseline-week52
Days of hospitalization
Tijdsspanne: baseline-week52

To describe direct Economic Burden.
baseline-week52
First aid visits
Tijdsspanne: baseline-week52

To describe direct Economic Burden
baseline-week52
General practitioner visits
Tijdsspanne: baseline-week52

To describe direct Economic Burden
baseline-week52
Ear-nose-throat outpatient department visit
Tijdsspanne: baseline-week52

To describe direct Economic Burden
baseline-week52
Total outpatient department visit
Tijdsspanne: baseline-week52

To describe direct Economic Burden
baseline-week52
Outpatient (Expense per visit, Total expense within 1 year post-operatively)
Tijdsspanne: week0-week52

To describe Healthcare Related Utilization
week0-week52
Emergency (Expense per visit, Total expense within 1 year post-operatively)
Tijdsspanne: week0-week52

To describe Healthcare Related Utilization
week0-week52
Inpatient (Expense per visit, Total expense within 1 year post-operatively)
Tijdsspanne: week0-week52

To describe Healthcare Related Utilization
week0-week52
Pharmacy (Expense per visit, Total expense within 1 year post-operatively)
Tijdsspanne: week0-week52

To describe Healthcare Related Utilization
week0-week52
Work productivity and activity impairment (WPAI)
Tijdsspanne: baseline-week52

To describe indirect burden
baseline-week52

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AstraZeneca

Onderzoekers

  • Hoofdonderzoeker: Weiping Wen, Professor, First Affiliated Hospital, Sun Yat-Sen University
  • Hoofdonderzoeker: Dongdong Zhu, Professor, China-Japan Union Hospital, Jilin University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 maart 2026

Primaire voltooiing (Geschat)

21 oktober 2027

Studie voltooiing (Geschat)

21 oktober 2027

Studieregistratiedata

Eerst ingediend

26 januari 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 februari 2026

Eerst geplaatst (Werkelijk)

3 maart 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

22 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • D5242R00005

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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 approved.

IPD-tijdsbestek voor delen

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-toegangscriteria voor delen

When a request has been approved, AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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