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Monoclonal Antibodies

Mepolizumab for Chronic Sinusitis with Nasal Polyps

Phase 4
Recruiting
Research Sponsored by St. Paul's Sinus Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are over the age of 19
Females of childbearing potential must commit to using an acceptable method of birth control for the duration of the study and they must have a negative urine pregnancy test at each study visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial will compare immune profiles of people with CRSwNP with/without asthma before/after treatment with Mepolizumab. Results could help tailor treatment for CRSwNP.

Who is the study for?
This trial is for adults over 19 with Chronic Rhinosinusitis and nasal polyps, with or without asthma. Participants must not be smokers, have a history of lung transplants, sinus or bronchial tumors, certain infections, autoimmune diseases, immunodeficiency or allergies to biologics. Women must use birth control and have negative pregnancy tests during the study.Check my eligibility
What is being tested?
The study compares immune responses in patients treated with Mepolizumab versus those given a placebo. It includes chronic rhinosinusitis sufferers both with and without nasal polyps but excludes individuals who've recently taken antibiotics or have specific health exclusions.See study design
What are the potential side effects?
While the trial description doesn't specify side effects of Mepolizumab, common ones may include headache, injection site reactions (pain or swelling), fatigue and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 19 years old.
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I am using birth control and have a negative pregnancy test.
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I have asthma and chronic rhinosinusitis without nasal polyps, and will only attend initial study visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare the immune profile in CRSwNP patients with and without asthma (before and after Mepolizumab treatment), and with asthmatic CRSsNP patients.
Secondary outcome measures
Examine the treatment response to Mepolizumab in CRSwNP patients with and without asthma.
Explore the effects of Mepolizumab compared to placebo in the treatment of Chronic Rhinosinusitis

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
9%
Pruritus
9%
Acute sinusitis
9%
Myalgia
9%
Musculoskeletal pain
9%
Productive cough
9%
Sinus congestion
7%
Wheezing
7%
Alanine aminotransferase increased
7%
Vertigo
7%
Respiratory tract infection
7%
Gastroenteritis
7%
Rhinitis
7%
Abdominal pain upper
7%
Cough
7%
Urinary tract infection
7%
Asthenia
7%
Pain in extremity
6%
Weight increased
6%
Nasal congestion
6%
Fungal skin infection
6%
Oral herpes
6%
Conjunctivitis
6%
Paraesthesia
6%
Urticaria
6%
Vision blurred
6%
Ligament sprain
4%
Aspartate aminotransferase increased
4%
Muscle spasms
4%
Skin lesion
4%
Adrenal insufficiency
4%
Hot flush
4%
Otitis media
4%
Viral infection
4%
Epistaxis
4%
Sneezing
4%
Dizziness
4%
Migraine
4%
Oedema peripheral
4%
Influenza like illness
4%
Cataract
4%
Eye pruritus
4%
Laceration
4%
Contusion
4%
Gamma-glutamyltransferase increased
3%
Insomnia
3%
Abdominal pain
3%
Upper-airway cough syndrome
3%
Injection site pain
3%
Sinus headache
3%
Joint swelling
1%
Nystagmus
1%
Ear discomfort
1%
Hernia
1%
Lacunar infarction
1%
Cerebellar ischaemia
1%
Cardiac arrest
1%
Pachymeningitis
1%
Facial paresis
1%
Dyspepsia
1%
Hypersensitivity
1%
Gastrooesophageal reflux disease
1%
Dyspnoea
1%
Enterococcal infection
1%
Parainfluenzae virus infection
1%
Perirectal abscess
1%
Chest pain
1%
Ear infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Mepolizumab 300mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MepolizumabExperimental Treatment1 Intervention
Mepolizumab (100 mg) subcutaneously every 4 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo 100 mg subcutaneously every 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mepolizumab
2020
Completed Phase 3
~4800

Find a Location

Who is running the clinical trial?

St. Paul's Sinus CentreLead Sponsor
3 Previous Clinical Trials
80 Total Patients Enrolled
1 Trials studying Chronic Sinusitis
40 Patients Enrolled for Chronic Sinusitis

Frequently Asked Questions

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

What potential risks could be associated with the use of Mepolizumab?

"There is ample evidence of Mepolizumab's safety, making it worthy of a score 3 on our scale. This treatment has already been approved for clinical use."

Answered by AI

How many subjects are being monitored in this clinical investigation?

"Affirmative. Clinicaltrials.gov's data affirms that this clinical experiment, which was first posted on July 1st 2023, is actively recruiting participants. Approximately 90 patients must be sourced from a solitary site."

Answered by AI

Are there any open opportunities for enrolment in this trial?

"Affirmative. Clinicaltrials.gov lists this clinical trial as currently recruiting patients, which first appeared on July 1st 2023 and was most recently updated October 27th 2023. To date, 90 participants are being recruited from a sole medical centre for the study's purposes."

Answered by AI

Who else is applying?

What site did they apply to?
St. Pual's Sinus Centre
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment
Dr. Andrew Thamboo, MD 2023. "Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05642806.
All > Pediatric Asthma > Asthma
~42 spots leftby Dec 2024
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