Omalizumab Efficacy in Chronic Rhinosinusitis Patients with Recurrent Nasal Polyp

Phase 3

Recruiting

Conditions: Efficacy of omalizumab in patients with Chronic rhino sinusitis and refractory nasal polyp.
Disease of respiratory disease

Registration Number: IRCT20220218054057N1

Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Investigation in Namazi Hospital Immunology -Allergy Clinic Complete the informed consent form Patients aged 18-75 years Usage of intranasal corticosteroid Nasal Polyp score 2 or more Total Congestion Nasal score 2 or higher SNOT22 score 20 or higher on arrival

Exclusion Criteria

The patients with other sinunasal or pulmonary disorders (except asthma) History of past or current malignancy History of a cardiac condition, hepatitis or liver cirrhosis History of recent or current infection requiring hospitalization History of recent use of immunosuppressant and biologics History of recent nasal surgery (<6 months). known allergy to omalizumab

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sini nasal outcome test -22. Timepoint: Day 1; and at Weeks 4, 8, 16, and 24. Method of measurement: Point range, 0-110,lower scores indicating better disease control and quality of life . The questionnaire includes 22 variables , and the severity of each item ranges from no symptoms with a score of 0 to very severe with a score of 5. Variables include the need to fan - Sneezing - Runny nose - Cough - Discharg from the back of the throat - Thick nasal discharge - Feeling full in the ears - Dizzness - Feeling pain with pressure in the ear - Feeling pain with pressure in the face - Hard sleep - Waking up in a dream Nocturnal - Lack of good night sleep - Laziness after waking up - Fatigue during the day - Low efficiency - Low concentration - Frustration and irritability - Sad - Embarrassed - Affected sense of taste or smell and blocked and stuffy nose.

Secondary Outcome Measures