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Omalizumab Efficacy in Patients With Refractory Nasal Polyps

NCT05405478 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-06-06

No results posted yet for this study

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 .

Conditions

  • Nasal Polyps

Interventions

DRUG

Omalizumab

subcutaneous injection every 2 or 4 weeks, depending on the pretreatment serum total IgE level and body weight

DIAGNOSTIC_TEST

SNOT22 score

score will measure at screening; on day 1; and at weeks 4, 8, 16, and 24 (point range, 0-110)

Sponsors & Collaborators

  • Shiraz University of Medical Sciences

    lead OTHER

Principal Investigators

  • hossein esmailzade · SUMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2022-12-23
Completion
2023-01-23
FDA Drug
Yes
FDA Device
Yes

Countries

  • Iran

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05405478 on ClinicalTrials.gov