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Mepolizumab for Chronic Sinusitis

Q: Are individuals aged 30 and older eligible for this research study?

The trial's eligibility requirements stipulate that the lower limit for age is 18 while the upper boundary stands at 100.

Q: Are there certain criteria for enrolling in this investigation?

Eligibility for this study is limited to persons between 18 and 100 years of age who suffer from chronic rhinosinusitis. A maximum of 8 patients can be accepted into the trial.

Q: How many participants are being recruited for this clinical trial?

Affirmative. Clinicaltrials.gov data reveals the recruitment effort for this clinical trial, which was first shared on September 5th 2023 is ongoing. The study requires 8 participants to be sourced from 2 different medical centres.

Q: Does this research endeavor welcome new participants?

Correct. The information located on clinicaltrials.gov confirms that recruitment for this medical trial is in progress, with the initial posting occuring on September 5th 2023 and the last update being October 9th of the same year. There are 8 participants needed to be enrolled from 2 sites total.

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 0 to 48 hours

Awards & highlights

Study Summary

This trial examines how a drug (mepolizumab) affects cells in the nose to suppress inflammation, and maintain barrier integrity.

Who is the study for?

This trial is for adults with chronic sinusitis and nasal polyps, confirmed by CT or endoscopy, experiencing symptoms like nasal blockage or reduced smell for over 12 weeks. It's not suitable for children under 18, pregnant/lactating women, prisoners, mentally disabled individuals who can't consent, or those recently on steroids/biologics.Check my eligibility

What is being tested?

The study tests Mepolizumab's effects on human nasal airway cells from chronic rhinosinusitis patients in a lab setting. It aims to determine how the drug reduces inflammation and maintains the integrity of the cell lining in these patients.See study design

What are the potential side effects?

While this study is conducted in vitro (outside a living organism), potential side effects of Mepolizumab generally include headache, injection site reactions, back pain, fatigue and allergic reactions.

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 CT scan or endoscopic exam shows sinus inflammation or infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 48 hours for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Innate immune inflammatory markers (ng/mL)

Change in Type 1 inflammatory markers (ng/mL)

Change in Type 2 inflammatory markers (ng/mL)

+2 more

Side effects data

From 2016 Phase 3 trial • 136 Patients • NCT02020889

32%

Headache

22%

Arthralgia

21%

Sinusitis

21%

Upper respiratory tract infection

18%

Diarrhoea

18%

Nasopharyngitis

16%

Nausea

16%

Vomiting

15%

Fatigue

15%

Asthma

13%

Injection site reaction

13%

Rash

12%

Back pain

12%

Oropharyngeal pain

12%

Neck pain

10%

Influenza

10%

Bronchitis

10%

Pyrexia

Pruritus

Acute sinusitis

Myalgia

Musculoskeletal pain

Productive cough

Sinus congestion

Wheezing

Alanine aminotransferase increased

Vertigo

Respiratory tract infection

Gastroenteritis

Rhinitis

Abdominal pain upper

Cough

Urinary tract infection

Asthenia

Pain in extremity

Weight increased

Nasal congestion

Fungal skin infection

Oral herpes

Conjunctivitis

Paraesthesia

Urticaria

Vision blurred

Ligament sprain

Aspartate aminotransferase increased

Muscle spasms

Skin lesion

Adrenal insufficiency

Hot flush

Otitis media

Viral infection

Epistaxis

Sneezing

Dizziness

Migraine

Oedema peripheral

Influenza like illness

Cataract

Eye pruritus

Laceration

Contusion

Gamma-glutamyltransferase increased

Insomnia

Abdominal pain

Upper-airway cough syndrome

Injection site pain

Sinus headache

Joint swelling

Nystagmus

Ear discomfort

Hernia

Lacunar infarction

Cerebellar ischaemia

Cardiac arrest

Pachymeningitis

Facial paresis

Dyspepsia

Hypersensitivity

Gastrooesophageal reflux disease

Dyspnoea

Enterococcal infection

Parainfluenzae virus infection

Perirectal abscess

Chest pain

Ear infection

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Mepolizumab 300mg

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mepolizumab treatment armExperimental Treatment1 Intervention

Nasal epithelial cells will be exposed in vitro to mepolizumab in culture.

Group II: Control armActive Control1 Intervention

Nasal epithelial cells will be exposed in vitro to media without mepolizumab in culture

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mepolizumab

2020

Completed Phase 3

~4800

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,489 Total Patients Enrolled

GlaxoSmithKlineIndustry Sponsor

4,755 Previous Clinical Trials

8,070,827 Total Patients Enrolled

Jean Kim, MD PhDPrincipal InvestigatorJohns Hopkins University

1 Previous Clinical Trials

8 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals aged 30 and older eligible for this research study?

"The trial's eligibility requirements stipulate that the lower limit for age is 18 while the upper boundary stands at 100."

Answered by AI

Are there certain criteria for enrolling in this investigation?

"Eligibility for this study is limited to persons between 18 and 100 years of age who suffer from chronic rhinosinusitis. A maximum of 8 patients can be accepted into the trial."

Answered by AI

How many participants are being recruited for this clinical trial?

"Affirmative. Clinicaltrials.gov data reveals the recruitment effort for this clinical trial, which was first shared on September 5th 2023 is ongoing. The study requires 8 participants to be sourced from 2 different medical centres."

Answered by AI

Does this research endeavor welcome new participants?

"Correct. The information located on clinicaltrials.gov confirms that recruitment for this medical trial is in progress, with the initial posting occuring on September 5th 2023 and the last update being October 9th of the same year. There are 8 participants needed to be enrolled from 2 sites total."

Answered by AI

Recent research and studies

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2023. "The Role of IL5 in Epithelial Cell Integrity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05895929.