Omalizumab Efficacy in Chronic Rhinosinusitis Patients with Recurrent Nasal Polyp

Omalizumab Efficacy in Chronic Rhinosinusitis Patients with Recurrent and Refractory Nasal Polyps, Randomized Clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220218054057N1

Enrollment

Registered

2023-01-24

Start date

2023-01-10

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

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

Interventions

Intervention 1: Intervention group: The first group includes the patient group that is treated with the drug Amalizumab, which is a 150 mg recombinant anti-human IgE compound manufactured by Novartis.

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRafat Noeiaghdam

Shiraz University of Medical Sciences

Noi.rafat@yahoo.com+98 71 3232 5500

Outcome results

None listed

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