Omalizumab Efficacy in Patients With Refractory Nasal Polyps

NCT05405478 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: 25130
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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. 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

Keywords

nasal polyps; rinosinusitis; omalizumab

Outcome Measures

Primary Outcomes (3)

• 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

  considering how severe the problem and how frequently it happens and determined how bad it is with choose the number; no problem :0 very mild:1 mild : 2 moderate:3 severe:4 as bad a it can be: 5 1-need to blow nose 2-sneezing 3-runny nose 4- cough 5-post nasal discharge 6-thick nasal discharge 7-ear fullness 8-dizzness 9- ear pain 10-facial pain or pressure 11-difficulty falling asleep 12-waking up at night 13-lack of a good night sleep 14-waking up tired 15-fatigue 16-reduce productivity 17-reduce concentration 18-frustrated 19-sad 20-embarrassed 21-sense of taste and smell 22-blockageor congestion of nose

  day 1

• SNOT-22 (Table 2) score will measure at Questionable screening; ;sino-nasal out come Test 22Quastionnaire week24 after treatment with omalizumab (point range, 0-110, )

  considering how severe the problem and how frequently it happens and determined how bad it is with choose the number; no problem :0 very mild:1 mild : 2 moderate:3 severe:4 as bad a it can be: 5 1-need to blow nose 2-sneezing 3-runny nose 4- cough 5-post nasal discharge 6-thick nasal discharge 7-ear fullness 8-dizzness 9- ear pain 10-facial pain or pressure 11-difficulty falling asleep 12-waking up at night 13-lack of a good night sleep 14-waking up tired 15-fatigue 16-reduce productivity 17-reduce concentration 18-frustrated 19-sad 20-embarrassed 21-sense of taste and smell 22-blockageor congestion of nose

  up to 24 weeks

• assesment last score of the Test-22 Questionnaire before and after treatment with omalizumab that is related to sino-nasal and auricular function,sleep quality,psychological impact, and productivity.

  patients are asked to recall their experience over a period of time and rate their symptoms on a severity scale from 0 to 5.they are also requested to identify up to 5 items that have the greatest impact on their health.

  average 1 month

Study Arms (2)

use of omalizumab in patients with refractory nasal polyp

EXPERIMENTAL

15 patients group with arrival criteria

Drug: Omalizumab; Diagnostic Test: SNOT22 score

control group patients with refractory nasal polyp

EXPERIMENTAL

15 patient that with arrival criteria cant arrive in the patients group

Diagnostic Test: SNOT22 score

Interventions

Omalizumab DRUG

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

Also known as: XOLAIR

use of omalizumab in patients with refractory nasal polyp

SNOT22 score DIAGNOSTIC_TEST

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

control group patients with refractory nasal polyp; use of omalizumab in patients with refractory nasal polyp

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Imam Reza Allergy and Immunology clinic, Shiraz University of Medical Sciences

Shiraz, Fars, 7186767431, Iran

Location

Related Publications (1)

• Gevaert P, Omachi TA, Corren J, Mullol J, Han J, Lee SE, Kaufman D, Ligueros-Saylan M, Howard M, Zhu R, Owen R, Wong K, Islam L, Bachert C. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol. 2020 Sep;146(3):595-605. doi: 10.1016/j.jaci.2020.05.032. Epub 2020 Jun 7.

  PMID: 32524991 RESULT

MeSH Terms

Conditions

Nasal Polyps

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• hossein esmailzade

  SUMS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hossein esmailzade, attending

CONTACT

09171052159; esmailzadeh_ho@yahoo.com

rafat noeiaghdam, fellow ship

CONTACT

09171153977; noi.rafat@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinicalprofessor

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: June 6, 2022
• Study Start: June 1, 2022
• Primary Completion: December 23, 2022
• Study Completion: January 23, 2023
• Last Updated: June 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: data of SNOT22 is analysis
• Access Criteria: improvement of SNOT22 score in patients versus control group

Locations

IR (1)