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Omalizumab for Sinus Infection and Nasal Polyps (CRSwNP Trial)

Q: What ailments is Omalizumab utilized to treat?

Patients suffering from perennial aeroallergen reactivity, or whose symptoms are not adequately managed using inhaled corticosteroids and non-sedating histamine H1 antagonists, may benefit from Omalizumab therapy.

Q: How many participants are actively taking part in this clinical research?

Affirmative. Clinicaltrials.gov's records suggest that this research study, which was published on December 15th 2020, is currently recruiting participants. 8 people are needed to be recruited from two different locations.

Q: Are there prior studies which have investigated Omalizumab?

At the moment, 22 scientific trials are being conducted on Omalizumab with 6 trials currently in their third phase. Although most of these tests take place in Newcastle upon Tyne and Cádiz , a total of 254 sites have been identified for experimentation.

Q: Am I eligible to volunteer for this experiment?

Specifically, this medical trial is searching for 8 adults aged 18 to 100 who have experienced sinonasal inflammation symptoms like nasal obstruction/congestion, discharge (anterior or posterior), facial pressure/<a href="https://www.withpower.com/clinical-trials/pain">pain</a> and reduction of their sense of smell over the course of 12 weeks. Furthermore, <a href="https://www.withpower.com/clinical-trials/all">all</a> potential participants must give written consent via an Institutional Review Board approved document before being enrolled in the study.

Q: Does this experimental program permit elderly individuals to take part?

This research is open to persons aged 18 and under 100 who wish to take part.

Q: Are new applicants currently being considered for this clinical experiment?

Affirmative. The data listed on clinicaltrials.gov states that this medical investigation, which was first made available on December 15th 2020, is presently seeking participants. 8 people are needed to be recruited from 2 distinct healthcare centres.

Phase < 1

Recruiting

Led By Jean Kim, MD PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Sinonasal inflammation for greater than 12 weeks which include at least 2 of the following symptoms: nasal obstruction/congestion, nasal discharge (anterior or posterior), facial pressure/pain, reduction of sense of smell

Confirmation of the clinical symptoms by CT scan evidence of paranasal sinus mucosal inflammation, and/or endoscopic exam evidence of purulence from the sinuses or ostiomeatal complex

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

CRSwNP Trial Summary

This trial is testing a new drug to see if it can help with chronic sinusitis and nasal polyps.

Who is the study for?

This trial is for adults aged 18-100 with chronic rhinosinusitis and nasal polyps, confirmed by CT or endoscopy. Participants must have had sinus inflammation for over 12 weeks with symptoms like congestion or reduced smell. Pregnant women, prisoners, mentally disabled individuals, those unable to consent, children under 18, and recent users of certain steroids or biologics are excluded.Check my eligibility

What is being tested?

The study tests Omalizumab's effects on human nasal polyp tissue from patients with chronic rhinosinusitis in a lab setting. It aims to identify specific markers of inflammation that can help understand how the drug works against this condition.See study design

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of Omalizumab may include injection site reactions (like pain or swelling), viral infections (such as colds), headaches, fatigue, and joint pain.

CRSwNP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had sinus inflammation for over 12 weeks with at least two symptoms like blocked nose, runny nose, facial pain, or loss of smell.

Select...

My sinus issues are confirmed by a CT scan or an endoscopic exam.

CRSwNP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

IgE tissue compartment distribution in nasal polyps as assessed by quantitative IgE expression

Messenger ribonucleic acid (mRNA) expression

Side effects data

From 2016 Phase 4 trial • 17 Patients • NCT02023151

77%

Infections

100%

80%

60%

40%

20%

Study treatment Arm

Omalizumab

CRSwNP Trial Design

1Treatment groups

Experimental Treatment

Group I: OmalizumabExperimental Treatment1 Intervention

Ex vivo exposure of excised human surgical polyp tissue to omalizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omalizumab

2006

Completed Phase 4

~2350

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,261 Previous Clinical Trials

14,821,060 Total Patients Enrolled

4 Trials studying Nasal Polyps

98 Patients Enrolled for Nasal Polyps

Genentech, Inc.Industry Sponsor

1,540 Previous Clinical Trials

567,891 Total Patients Enrolled

1 Trials studying Nasal Polyps

27 Patients Enrolled for Nasal Polyps

Jean Kim, MD PhDPrincipal InvestigatorJohns Hopkins University

1 Previous Clinical Trials

8 Total Patients Enrolled

1 Trials studying Nasal Polyps

8 Patients Enrolled for Nasal Polyps

Media Library

Omalizumab Clinical Trial Eligibility Overview. Trial Name: NCT04583501 — Phase < 1

Nasal Polyps Research Study Groups: Omalizumab

Nasal Polyps Clinical Trial 2023: Omalizumab Highlights & Side Effects. Trial Name: NCT04583501 — Phase < 1

Omalizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04583501 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ailments is Omalizumab utilized to treat?

"Patients suffering from perennial aeroallergen reactivity, or whose symptoms are not adequately managed using inhaled corticosteroids and non-sedating histamine H1 antagonists, may benefit from Omalizumab therapy."

Answered by AI

How many participants are actively taking part in this clinical research?

"Affirmative. Clinicaltrials.gov's records suggest that this research study, which was published on December 15th 2020, is currently recruiting participants. 8 people are needed to be recruited from two different locations."

Answered by AI

Are there prior studies which have investigated Omalizumab?

"At the moment, 22 scientific trials are being conducted on Omalizumab with 6 trials currently in their third phase. Although most of these tests take place in Newcastle upon Tyne and Cádiz , a total of 254 sites have been identified for experimentation."

Answered by AI

Am I eligible to volunteer for this experiment?

"Specifically, this medical trial is searching for 8 adults aged 18 to 100 who have experienced sinonasal inflammation symptoms like nasal obstruction/congestion, discharge (anterior or posterior), facial pressure/pain and reduction of their sense of smell over the course of 12 weeks. Furthermore, all potential participants must give written consent via an Institutional Review Board approved document before being enrolled in the study."

Answered by AI

Does this experimental program permit elderly individuals to take part?

"This research is open to persons aged 18 and under 100 who wish to take part."

Answered by AI

Are new applicants currently being considered for this clinical experiment?

"Affirmative. The data listed on clinicaltrials.gov states that this medical investigation, which was first made available on December 15th 2020, is presently seeking participants. 8 people are needed to be recruited from 2 distinct healthcare centres."

Answered by AI