Omalizumab Efficacy in Patients With Refractory Nasal Polyps

• Status: Not yet recruiting
• Trial end date: 2023-01-23
• Target enrollment: 0
• Participant gender: All

Summary

in patients with chronic rhinosinusitis with nasal polyps and concomitant asthma, they have a poor therapeutic response and a higher recurrence rate, and treatment in these patients often fails.

investigators conducted this study to survey the efficacy of Omalizumab (anti IgE) on patients with refractory nasal polyp to confirm its efficacy entering to treatment guidelines.SNOT-22 score will measure at screening; on day 1; and at weeks 4, 8, 16, and 24 (point range, 0-110, with lower scores indicating better disease control and quality of life .

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shiraz University of Medical Sciences
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• The patients which have been investigated in Nemazee hospital immune-allergy clinic

• Patients who completed the informed consent form

• The Patients aged 18-75 years with a history of sinus surgery at least once and usage of intranasal corticosteroid for at least 4 weeks

• The patients having a total nasal polyp score (NPS) 5 or more ( NPS >2 for each nostril)

• The patients having a nasal congestion score (NCS) of 2 or higher (with additional symptoms of postnasal drip, runny nose, and/or loss of sense of smell

• The patients having a SNOT-22 score of 20 or higher on arrival

Exclusion Criteria:

• The patients with other sinonasal or pulmonary disorders (except asthma), including current upper respiratory tract infection, cystic fibrosis, or other dyskinetic ciliary syndrome

• History of past or current malignancy

• History of a cardiac condition, hepatitis or liver cirrhosis

• History of recent or current infection requiring hospitalization (<4 weeks, antibiotic (<2 weeks) or antifungal treatment, or parasitic infection (<6 months)

• History of recent use of systemic corticosteroid (SCS) (<2 months), immunosuppressant, biologic, or leukotriene antagonist or modifier

• Hist.ory of recent nasal surgery (<6 months); known allergy to omalizumab; or those who were immunocompromised