A Study to Investigate the Clinical Outcome and Quality of Life in Chinese Post-operative CRSwNP Patients

AstraZeneca200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Interventions

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 CRSwNP. 3. Endoscopic nasal polypectomy is performed during the screening period. 4. Voluntarily participate and sign the informed consent form as described in A 3. 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. Currently participating in an interventional study. 3. Patients who are unable to independently complete questionnaires due to language barriers or mental status.

Locations (18)

Research Site

Changchun, China

RECRUITING

Research Site

Changsha, China

Outcomes

Primary Outcomes

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

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

Time frame: week0-52

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

Assess the opacification of the paranasal sinuses by using Modified Lund-Kennedy (MLK) score at week 52. \[MLK score: score 0-24, 24 means worse outcome\]

Time frame: week0-52

Secondary Outcomes

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

Assess the changes in post-operative symptom by Visual Analogue Scale(VAS) total sinus symptoms . \[VAS: score 0-10, 10 indicates worse outcome\]

Time frame: week0-52

Changes in NPS from baseline at each collection point

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

Time frame: week0-52

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

Assess the changes in post-operative symptom by Visual Analogue Scale(VAS) Nasal blockage item . \[VAS: score 0-10, 10 indicates worse outcome\]

Time frame: week0-52

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

Assess the changes in post-operative symptom by Sinonasal outcome test-22(SNOT-22) Smell/taste Item Score. \[SNOT-22: score 0-5 for each item, 5 means worse outcome\]

Time frame: week0-52

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Research Site

Chengdu, China

RECRUITING

Research Site

Guangzhou, China

RECRUITING

Research Site

Guangzhou, China

RECRUITING

Research Site

Guangzhou, China

RECRUITING

Research Site

Haikou, China

RECRUITING

Research Site

Kunming, China

RECRUITING

Research Site

Nanchang, China

RECRUITING

Research Site

Nanjing, China

RECRUITING

...and 8 more locations

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

Assess the changes in post-operative symptom by Sinonasal outcome test-22(SNOT-22) Nasal Congestion Item Score. \[SNOT-22: score 0-5 for each item, 5 means worse outcome\]

Time frame: week0-52

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

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

Time frame: week0-52

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

Assess the changes in post-operative symptom by Sinonasal outcome test-22(SNOT-22) Loss of Smell Item Score. \[SNOT-22: score 0-5 for each item, 5 means worse outcome\]

Time frame: week0-52

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

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

Time frame: week0-52

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

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

Time frame: week0-52

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

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.

Time frame: week0-52

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

Assess the changes in post-operative Quality of Life by Sinonasal outcome test-22(SNOT-22) top five items' frequency counts and average score. \[SNOT-22: score 0-5 for each item, 5 means worse outcome\]

Time frame: week0-52

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

Assess the changes in post-operative Sleep Quality by Sinonasal outcome test-22(SNOT-22) top five items' frequency counts and average score. \[SNOT-22: score 0-5 for each item, 5 means worse outcome\]

Time frame: week0-52

The proportion of patients using Intranasal corticosteroids (INCS)

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

Time frame: week0-52

Systemic glucocorticoids use for CRSwNP and asthma

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.

Time frame: week0-52

Antibiotics use for CRSwNP and asthma

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.

Time frame: week0-52

Biologics use for CRSwNP and asthma

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.

Time frame: week0-52

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

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.

Time frame: week0-52

Proportion of other related medications used.

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

Time frame: week0-52

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

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

Time frame: week0-52

Time to first recurrence

Assess the time to first recurrence in patients post-operatively

Time frame: week0-52

Proportion of Recurrence

Assess the time to first recurrence in patients post-operatively

Time frame: week0-52

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)

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

Time frame: week0-52

Assess the proportion of clinically meaningful improvement patients post-operatively

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

Time frame: week0-52

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

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

Time frame: week0-52

Post-operative complications

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

Time frame: week0-52

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

Assess asthma (for asthma participants only)

Time frame: week0-52

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

Assess asthma (for asthma participants only) by ACQ-5. \[ACQ-5: score 0-6 for each item, 6 means worse outcome\]

Time frame: week0-52

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

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

Time frame: week0-52

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

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

Time frame: week0-52

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

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).

Time frame: week0-52