Omalizumab Efficacy in Patients With Refractory Nasal Polyps

Sponsor
Shiraz University of Medical Sciences
Study ID
NCT05405478
Phase
PHASE4
Status
Unknown

Conditions

  • Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    subcutaneous injection every 2 or 4 weeks, depending on the pretreatment serum total IgE level and body weight
  • SNOT22 score — DIAGNOSTIC_TEST
    score will measure at screening; on day 1; and at weeks 4, 8, 16, and 24 (point range, 0-110)

Study Details

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 .

Key Dates

Start date
Jun 1, 2022
Status verified
May 2022
Primary completion
Dec 23, 2022
Completion
Jan 23, 2023

Study Design

Enrollment
2 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: use of omalizumab in patients with refractory nasal polyp
    15 patients group with arrival criteria
  • Experimental: control group patients with refractory nasal polyp
    15 patient that with arrival criteria cant arrive in the patients group

Primary Outcome Measure

SNOT-22 (Table 2) score will measure at Questionable screening; on day 1 before treatment with omalizumab (point range, 0-110, );sino-nasal out come Test 22Quastionnaire [ Time Frame: day 1 ]

Central Contacts

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