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NCT Number: NCT07446738

A Study to Investigate 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).

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Sex eligibility

All sexes

Study type

Observational

Primary location

The Seventh Affiliated Hospital Sun Yat-sen University, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Use of biologic therapy for CRSwNP within 3 months prior to surgery.
  • Currently participating in an interventional study.
  • Patients who are unable to independently complete questionnaires due to language barriers or mental status.

Treatment and study plan

Other: Routine Clinical Care for CRSwNP

Other

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.

Primary outcomes

  1. The observed value and change from baseline in SNOT-22 total score at week-52

    Time frame: 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]

  2. The observed value and change from baseline in MLK score at week-52

    Time frame: baseline-week52

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

Secondary outcomes

  1. The observed values and changes from baseline at each collection point: VAS - Total sinus symptoms item

    Time frame: 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]

  2. The observed values and changes from baseline in NPS at each collection point

    Time frame: baseline-week52

    To describe the changes in post-operative by Nasal Polyp Score (NPS). [NPS: score 0-4, 4 indicates worse outcome]

  3. The observed values and changes from baseline at each collection point: VAS - Nasal blockage item

    Time frame: 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]

  4. The observed values and changes from baseline at each collection point: SNOT-22 Smell/taste Item Score

    Time frame: 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]

  5. The observed values and changes from baseline at each collection point: SNOT-22 Nasal Congestion Item Score

    Time frame: 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]

  6. The observed values and changes from baseline at each collection point: Nasal Congestion Score (NCS)

    Time frame: baseline-week52

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

    [NCS: score 0-3, 3 indicates worse outcome]

  7. The observed values and changes from baseline at each collection point: Loss of Smell

    Time frame: 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]

  8. The observed values and changes from baseline at each collection point: Nasal Airway Resistance (NAR)

    Time frame: baseline-week52

    To describe the changes in post-operative symptom by Nasal Airway Resistance(NAR).

  9. Pre-operative, 24-week post-operatively, and 52- week post-operative Lund-Mackay CT Scores.

    Time frame: week0-52

    To describe the changes in post-operative CT Scores

  10. The observed values and cChanges from baseline at each collection point: SF-36((Short Form Health Survey)

    Time frame: 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.

  11. The observed values and changes from baseline at each collection point: The SNOT-22 top five items' frequency counts and average score

    Time frame: 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]

  12. The observed values and changes from baseline at each collection point: SNOT-22 sleep domain

    Time frame: baseline-week52

    To describe the changes in post-operative Sleep Quality [SNOT-22: score 0-5 for each item, 5 means worse outcome]

  13. Intranasal corticosteroids (INCS): the proportion of participants using INCS.

    Time frame: 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).

  14. The daily dosage of participants used Systemic glucocorticoids (SCSs) for CRSwNP

    Time frame: 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

  15. Proportion of participants who used Antibiotics for CRSwNP at least once

    Time frame: 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.

  16. Proportion of participants who used biologics for CRSwNP at least once

    Time frame: 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.

  17. Proportion of participants who used ICS/LABA for asthma at least once.

    Time frame: 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.

  18. Proportion of other related medications used.

    Time frame: week0-52

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

  19. The proportion of participants requiring surgery within one year and the number of surgery

    Time frame: week0-52

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

  20. Time to first recurrence

    Time frame: week0-52

    To describe the time to first recurrence and proportion of participants with recurrence

  21. Proportion of participants with recurrence

    Time frame: week0-52

    To describe the time to first recurrence and proportion of participants with recurrence

  22. 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)

    Time frame: week0-52

    To describe the proportion of post-operative participants demonstrating clinically meaningful improvement at Week-52 and Week-4

  23. 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)

    Time frame: 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]

  24. 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)

    Time frame: 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]

  25. The proportion of participants with post-operative complications

    Time frame: week0-52

    Post-operative complications by

    •The proportion of participants with complications.

  26. Changes from baseline at each collection point: Spirometry (pre-BD FEV1)

    Time frame: baseline-week52

    To describe asthma-related outcomes (for asthma participants only)

  27. Changes from baseline at each collection point: Asthma Control Questionnaire-5(ACQ-5)

    Time frame: baseline-week52

    To describe asthma-related outcomes (for asthma participants only) [ACQ-5: score 0-6 for each item, 6 means worse outcome]

  28. Pre-operative, 24-week post-operatively, and 52-week ethmoid/maxillary sinuses (E/M) ratio

    Time frame: week0-52

    To describe the changes in post-operative ethmoid/maxillary sinuses (E/M) ratio.

  29. Pre-operative, 24-week post-operatively, and 52-week Olfactory Cleft Scores(NCS)

    Time frame: week0-52

    To describe the changes in post-operative Olfactory Cleft Scores(NCS). [NCS: score 0-3, 3 means worse outcome]

  30. The number of days of use intranasal corticosteroids (INCS).

    Time frame: 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).

  31. The proportion of participants who used Systemic glucocorticoids (SCSs) for CRSwNP

    Time frame: 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.

  32. Number of days of treatment with Systemic glucocorticoids (SCSs) for CRSwNP.

    Time frame: 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.

  33. The proportion of participants who used Systemic glucocorticoids (SCSs) for asthma

    Time frame: 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.

  34. The daily dosage of participants used Systemic glucocorticoids (SCSs) for asthma

    Time frame: 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

  35. Number of days of treatment with Systemic glucocorticoids (SCSs) for asthma.

    Time frame: 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.

  36. Number of days of treatment with Antibiotics for CRSwNP

    Time frame: week0-52

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

    • The number of use days.

  37. Proportion of participants who used Antibiotics for asthma at least once

    Time frame: 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.

  38. Number of days of treatment with Antibiotics for asthma

    Time frame: week0-52

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

    • The number of use days.

  39. Number of days of treatment with ICS/LABA for asthma

    Time frame: week0-52

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

    • The number of use days.

  40. Proportion of participants who used ICS/LABA/LAMA for asthma at least once.

    Time frame: 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.

  41. Number of days of treatment with ICS/LABA/LAMA for asthma

    Time frame: week0-52

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

    • The number of use days.

  42. The types of post-operative complications

    Time frame: week0-52

    Post-operative complications by

    •The types of post-operative complications.

  43. The number of post-operative complications occurrences.

    Time frame: week0-52

    Post-operative complications by

    •The number of complication occurrences.

  44. Proportion of participants who used biologics for asthma

    Time frame: 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.

  45. The frequency of use biologics for CRSwNP

    Time frame: week0-52

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

    • The frequency of use.

  46. The frequency of use biologics for asthma

    Time frame: week0-52

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

    • The frequency of use.

Other outcomes

  1. T2：bEOS≥150 cells/μL or Tissue EOS≥10/hpf or Total IgE≥100 IU/ml.

    Time frame: Baseline

    Proportion of different inflammatory subtype at baseline.

  2. bEOS: <150，150-300，≥300 cells/μL.

    Time frame: Baseline

    Proportion of different inflammatory subtype at baseline.

  3. Tissue EOS≥10/hpf.

    Time frame: Baseline

    Proportion of different inflammatory subtype at baseline.

  4. Total IgE≥100 IU/ml.

    Time frame: Baseline

    Proportion of different inflammatory subtype at baseline.

  5. Baseline characteristics of patients with recurrence.

    Time frame: 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

  6. Differences in characteristics between patients with clinically meaningful improvement and those without at week-52 and week-4 after surgery.

    Time frame: 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

  7. Number of participants with AEs, ADRs, and special situations associated with identified AstraZeneca products used for CRSwNP and/or asthma treatment if any.

    Time frame: 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.

  8. Proportion of participants with AEs, ADRs, and special situations associated with identified AstraZeneca products used for CRSwNP and/or asthma treatment if any.

    Time frame: 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.

  9. Days of hospitalization

    Time frame: baseline-week52

    To describe direct Economic Burden.

  10. First aid visits

    Time frame: baseline-week52

    To describe direct Economic Burden

  11. General practitioner visits

    Time frame: baseline-week52

    To describe direct Economic Burden

  12. Ear-nose-throat outpatient department visit

    Time frame: baseline-week52

    To describe direct Economic Burden

  13. Total outpatient department visit

    Time frame: baseline-week52

    To describe direct Economic Burden

  14. Outpatient (Expense per visit, Total expense within 1 year post-operatively)

    Time frame: week0-week52

    To describe Healthcare Related Utilization

  15. Emergency (Expense per visit, Total expense within 1 year post-operatively)

    Time frame: week0-week52

    To describe Healthcare Related Utilization

  16. Inpatient (Expense per visit, Total expense within 1 year post-operatively)

    Time frame: week0-week52

    To describe Healthcare Related Utilization

  17. Pharmacy (Expense per visit, Total expense within 1 year post-operatively)

    Time frame: week0-week52

    To describe Healthcare Related Utilization

  18. Work productivity and activity impairment (WPAI)

    Time frame: baseline-week52

    To describe indirect burden

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: PREDICT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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