← Back to Search

Monoclonal Antibodies

Benralizumab for Asthma (CHINOOK Trial)

Phase 4
Recruiting
Led By Mario Castro, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fewer than 12 exacerbations within the 6 months prior to Visit 3
Fewer than 12 exacerbations within the 6 months prior to Visit 3.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 52 (visit 11)
Awards & highlights

CHINOOK Trial Summary

This trial will help assess the effect of benralizumab on structural and lung function changes in severe asthmatics over a 48-week period.

Who is the study for?
Adults aged 18-70 with severe eosinophilic asthma, not well-controlled despite using inhaled steroids and long-acting beta agonists. They must have specific levels of blood eosinophils and less than 12 asthma attacks in the past six months. Excluded are those who've had certain treatments like benralizumab or bronchial thermoplasty recently, current smokers, cancer patients, pregnant women, or those on immunosuppressants.Check my eligibility
What is being tested?
The trial is testing if benralizumab can improve lung structure and function over a 48-week period compared to a placebo in patients with severe eosinophilic asthma. Participants will be monitored for changes after treatment and during a four-week follow-up.See study design
What are the potential side effects?
While not specified here, common side effects of benralizumab may include headache, sore throat, fever; rare but serious effects could involve allergic reactions or worsening breathing problems.

CHINOOK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've had fewer than 12 asthma attacks in the last 6 months.
Select...
I've had fewer than 12 flare-ups of my condition in the last 6 months.
Select...
I am between 18 and 70 years old.
Select...
I have asthma treated with strong medication for over a year.

CHINOOK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 52 (visit 11)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 52 (visit 11) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The change in airway wall area percentage as the overall median for airway generations 3 and 4 combined as measured by quantitative computed tomography (QCT) imaging
The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
Secondary outcome measures
Absolute change from baseline to End of Treatment in mucus score assessed using computed tomography (CT) scans
Absolute change in R5-R20 (peripheral airway resistance defined as the difference in resistance between 5 Hz [R5, total respiratory system resistance] and 20 Hz [R20, central resistance]) as measured by airwave oscillometry (AO)
Lung
+32 more
Other outcome measures
The number of Adverse events (AEs)/serious adverse events (SAEs).

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255
16%
Nasopharyngitis
11%
Bronchitis
8%
Headache
8%
Rhinitis
7%
Upper respiratory tract infection
5%
Sinusitis
4%
Hypertension
4%
Vertigo
3%
Back pain
3%
Pneumonia
1%
Asthma
1%
Cough
1%
Dyspnoea
1%
Cardiac failure acute
1%
Atrial fibrillation
1%
Presyncope
1%
Influenza
1%
Oesophagitis
1%
Gallbladder polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.8 Weeks
Benra 30 mg q.4 Weeks
Placebo

CHINOOK Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BenralizumabExperimental Treatment1 Intervention
Administrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks
Group II: PlaceboPlacebo Group1 Intervention
Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 3
~10580

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,265 Previous Clinical Trials
288,605,201 Total Patients Enrolled
328 Trials studying Asthma
639,553 Patients Enrolled for Asthma
Mario Castro, MDPrincipal InvestigatorUniversity of Kansas School of Medicine 3901 Rainbow Blvd. Kansas City, KS 66160, USA
6 Previous Clinical Trials
2,236 Total Patients Enrolled
6 Trials studying Asthma
2,236 Patients Enrolled for Asthma

Media Library

Benralizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03953300 — Phase 4
Asthma Research Study Groups: Placebo, Benralizumab
Asthma Clinical Trial 2023: Benralizumab Highlights & Side Effects. Trial Name: NCT03953300 — Phase 4
Benralizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03953300 — Phase 4

Frequently Asked Questions

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

What are the key aims of this experiment?

"This clinical trial, lasting from baseline to Week 48 (Visit 10), will examine the change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein staining. Secondary outcomes include changes from pre-bronchodilator whole body plethysmogrpahy functional residual capacity, assessments of peripheral airway resistance measured by AO and absolute change in post-bronchodilator WBP RV/TLC ratio."

Answered by AI

Are there still opportunities to join this trial at the present time?

"Affirmative. Clinicaltrials.gov provides evidence to demonstrate that this medical research project, which was launched on October 17th 2019, is currently recruiting test subjects. Eighty-one individuals are needed at eight separate locations."

Answered by AI

How many participants are signed up for this medical research?

"Affirmative. The information on clinicaltrials.gov verifies that this study is actively recruiting participants, which was first posted on October 17th 2019 and most recently updated November 4th 2022. Subsequently, 81 patients across 8 medical centres need to be enrolled in the trial."

Answered by AI

Are there any prior experiments utilizing Benralizumab that have already been completed?

"Benralizumab was initially researched at the National Institutes of Health Clinical Center, 9000 Rockville Pike in 2014. Since then, 18348 completed clinical trials have been documented and 20 are actively recruiting subjects with many sites located in Los Angeles, CA."

Answered by AI

Who is eligible to partake in this clinical investigation?

"This medical trial seeks 81 participants who are aged 18 to 70, and have a diagnosis of asthma."

Answered by AI

Is this a pioneering trial in comparison to other studies?

"Since it was first tested in 2014, over 18348 trials of benralizumab have been completed across 352 cities and 42 countries. Initially sponsored by AstraZeneca, the initial trial involved 20 participants who successfully navigated Phase 2 & 3 drug approval stage."

Answered by AI

In what specific areas is this clinical trial being conducted?

"This clinical trial is taking place at 8 distinct locations, among them Los Angeles, Port Jefferson Station and Saint Louis. To make the process easier for enrollees, they are encouraged to choose a site that requires minimal commuting."

Answered by AI

Are those below the age of 50 permitted to take part in this investigation?

"The upper and lower age limits for this clinical trial are 18 years of age and 70 years old, respectively."

Answered by AI

Has Benralizumab gained government authorization for usage?

"With a score of 3, our team at Power deems benralizumab to be safe as this treatment has been approved for use after phase 4 clinical trials."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
2019. "Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03953300.
All > Pediatric Asthma > Asthma
~28 spots leftby Sep 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top