Health TrialsbyHealthPanel

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

ConditionChronic Rhinosinusitis With Nasal Polyps
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Chinese CRSwNP Patients

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Endoscopic Sinus Surgery (ESS)

    Procedure/Surgery

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Standard of Care Endoscopic Sinus Surgery (ESS)1 intervention

Trial outcomes

Primary outcomes

1

• 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
2

• 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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
Apply now