Study on the efficacy and mechanism of ormazumab in the postoperative treatment of patients with chronic rhinosinusitis with nasal polyps combined with asthma in China

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100047069

Enrollment

Unknown

Registered

2021-06-07

Start date

2021-09-01

Completion date

Unknown

Last updated

2022-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic rhinosinusitis with nasal polyps

Interventions

control group:standard-of-care (SoC) treatment (Budesonide spray 64ug/side, 2 times) / Day + nasal rinse 1 time / day) 6 months

Experimental group:SoC treatment plus omalizumab 6 months

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Diagnosis of CRSwNP and asthma meet the standard of EPOS 2020 and Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines; 2.CRSwNP patients aged 18 to 65 years combine with asthma after FESS more than 3 months; 3.The score of SNOT-22 over than 30; 4.30 IU/mL = 20 points.

Exclusion criteria

Exclusion criteria: 1.Women during pregnancy, prepare for pregnancy and lactation; 2.Patients who allergic to omalizumab; 3.Patients with the serious disease of liver and kidney, immune system diseases, blood diseases, parasitic infections, tumors, poor general condition and mental illness; 4.Patients treated with system glucocorticoid therapy within 2 months before login in; 5.Patients with acute asthma episode and other lung diseases; 6.Patients with primary ciliary dyskinesia, chronic granulomatosis disease and granulomatous arteritis; 7.Patients with antrochoanal polyp and fungal sinusitis; 8.Patients who cannot use nasal glucocorticoid; 9.Patients who receives other nasal treatments for CRSwNP; 10.Patients with acute sinusitis or nasal infections; 11.Patients who abuse of alcohol, drugs and chemical agents.

Design outcomes

Primary

Measure	Time frame
the count of eosinophils in nasal polyps' tissue;	—

Secondary

Measure	Time frame
total nasal cavity volume;Sinonasal Outcome Test-22;visual analog scale score;Lund-Kenndy score;Fractional exhaled nitric oxide;asthma control test;pulmonary function;total nasal resistance;peripheral blood eosinophils count;biomarkers;	—

Countries

China

Contacts

Public ContactWang Chengshuo

Beijing Institute of Otolaryngology

wangcs830@126.com+86 10 58265804

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026