Status:
UNKNOWN
Omalizumab Efficacy in Patients With Refractory Nasal Polyps
Lead Sponsor:
Shiraz University of Medical Sciences
Conditions:
Nasal Polyps
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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. inve...
Detailed Description
Nasal polyps are benign edematous masses in the nasal cavities, paranasal cavities, or both with a probable overall prevalence of approximately 2% to 4% that can cause nasal obstruction, rhinorrhea, p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 23 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05405478
Start Date
June 1 2022
End Date
January 23 2023
Last Update
June 6 2022
Active Locations (1)
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1
Imam Reza Allergy and Immunology clinic, Shiraz University of Medical Sciences
Shiraz, Fars, Iran, 7186767431