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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 study to describe the postoperative outcomes and quality of life, disease control and characteristics of patients who underwent surgery, as well as economic burden and post-operative treatment patterns in Chinese patients with CRSwNP recurrence.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Changchun, China

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About this study

This is a prospective, multicenter real-world study to describe the postoperative outcomes and quality of life, disease control and characteristics of patients who underwent surgery, as well as economic burden and post-operative treatment patterns in Chinese patients with CRSwNP. Patients will receive standard medical care as determined by the treating physician at each site and undergo scheduled clinical assessments.

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

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 CRSwNP.
  • Endoscopic nasal polypectomy is performed during the screening period.
  • Voluntarily participate and sign the informed consent form as described in A 3.
  • 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.
  • 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

Endoscopic sinus surgery (ESS)

Procedure

This is a standard of care surgical procedure performed according to clinical routine. No experimental treatment or investigational drug is administered as part of this study.

Primary outcomes

  1. • The observed and change from baseline of Sino-Nasal Outcome Test (SNOT)-22 score at week-52

    Time frame: week0-52

    Assess the Change in Sinonasal outcome test-22(SNOT-22) at 52 weeks post-operatively [SNOT-22: score 0-5 each item, 5 means worse outcome, 22 items totally]

  2. • The observed and change from baseline of Modified Lund-Kennedy (MLK) score at week-52

    Time frame: week0-52

    Assess the opacification of the paranasal sinuses by using Modified Lund-Kennedy (MLK) score at week 52.

    [MLK score: score 0-24, 24 means worse outcome]

Secondary outcomes

  1. Changes from baseline at each collection point: • VAS - Total sinus symptoms item

    Time frame: week0-52

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

    [VAS: score 0-10, 10 indicates worse outcome]

  2. Changes in NPS from baseline at each collection point

    Time frame: week0-52

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

  3. Changes from baseline at each collection point: • VAS - Nasal blockage item

    Time frame: week0-52

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

    [VAS: score 0-10, 10 indicates worse outcome]

  4. Changes from baseline at each collection point: • SNOT-22 Smell/taste Item Score

    Time frame: week0-52

    Assess 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. Changes from baseline at each collection point: • SNOT-22 Nasal Congestion Item Score

    Time frame: week0-52

    Assess 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. Changes from baseline at each collection point: • Nasal Congestion Score (NCS)

    Time frame: week0-52

    Assess the changes in post-operative symptom by Nasal Congestion Score(NCS). [NCS: score 0-3, 3 indicates worse outcome]

  7. Changes from baseline at each collection point: • Sinonasal outcome test-22(SNOT-22) Loss of Smell

    Time frame: week0-52

    Assess the changes in post-operative symptom by Sinonasal outcome test-22(SNOT-22) Loss of Smell Item Score.

    [SNOT-22: score 0-5 for each item, 5 means worse outcome]

  8. Changes from baseline at each collection point: • Nasal Airway Resistance (NAR)

    Time frame: week0-52

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

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

    Time frame: week0-52

    Assess the changes in post-operative Lund-Mackay CT Scores

  10. Changes from baseline at each collection point: • SF-36((Short Form Health Survey)

    Time frame: week0-52

    Assess 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. Changes from baseline at each collection point: • The Sinonasal outcome test-22(SNOT-22) top five items' frequency counts and average score

    Time frame: week0-52

    Assess 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. Changes from baseline at each collection point: • Sinonasal outcome test-22(SNOT-22) sleep domain

    Time frame: week0-52

    Assess the changes in post-operative Sleep Quality 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]

  13. The proportion of patients using Intranasal corticosteroids (INCS)

    Time frame: week0-52

    Assess the post-operative medication use and participants requiring surgery within one year post-operatively by the proportion of patients using Intranasal corticosteroids (INCS).

  14. Systemic glucocorticoids use for CRSwNP and asthma

    Time frame: week0-52

    Assess the post-operative medication use and participants requiring surgery within one year post-operatively by：

    • Proportion of patients who used at least once.
    • The daily dosage (convert according to the equivalent dose of prednisone.)
    • And the number of use days.

  15. Antibiotics use for CRSwNP and asthma

    Time frame: week0-52

    Assess the post-operative medication use and participants requiring surgery within one year post-operatively by:

    • Proportion of patients who used at least once.
    • The number of use days.

  16. Biologics use for CRSwNP and asthma

    Time frame: week0-52

    Assess the post-operative medication use and participants requiring surgery within one year post-operatively by:

    • Proportion of patients who used at least once.
    • The frequency of use.

  17. ICS/LABA or ICS/LABA/LAMA use for asthma

    Time frame: week0-52

    Assess the post-operative medication use and participants requiring surgery within one year post-operatively by

    • Proportion of patients who used at least once.
    • The number of use days.

  18. Proportion of other related medications used.

    Time frame: week0-52

    Assess the post-operative medication use and participants requiring 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

    Assess the post-operative medication use and participants requiring surgery within one year post-operatively

  20. Time to first recurrence

    Time frame: week0-52

    Assess the time to first recurrence in patients post-operatively

  21. Proportion of Recurrence

    Time frame: week0-52

    Assess the time to first recurrence in patients post-operatively

  22. Week-52 and week-4 proportion of clinically meaningful improvement patients based on: Nasal Congestion Score (NCS) (MCID relative to pre-operative of -1.0)

    Time frame: week0-52

    Assess the proportion of clinically meaningful improvement patients post-operatively at Week-52 and Week-4

  23. Assess the proportion of clinically meaningful improvement patients post-operatively

    Time frame: week0-52

    Assess the proportion of clinically meaningful improvement patients post-operatively based on: Sinonasal outcome test-22(SNOT-22) total score, with a Minimum Clinically Important Difference (MCID) relative to pre-operative of -8.9 at Week-52 and Week-4.

    [SNOT-22: score 0-5 for each item, 5 means worse outcome]

  24. Week-52 and week-4 proportion of clinically meaningful improvement patients

    Time frame: week0-52

    Assess the proportion of clinically meaningful improvement patients post-operatively at Week-52 and Week-4 by Visual Analogue Scale(VAS) for nasal blockage item (MCID relative to pre-operative of -3).

    [VAS scale: 0-10,10 means worse outcome]

  25. Post-operative complications

    Time frame: week0-52

    Post-operative complications by

    • The proportion of patients with complications.
    • The types of post-operative complications.
    • And the number of complication occurrences.

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

    Time frame: week0-52

    Assess asthma (for asthma participants only)

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

    Time frame: week0-52

    Assess asthma (for asthma participants only) by ACQ-5. [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

    Assess 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

    Assess 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

    Assess the post-operative medication use and participants requiring surgery within one year post-operatively by the number of days of use intranasal corticosteroids (INCS).

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

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 CRSwNP Patients

Acronym: PREDICT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
Jul 8, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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