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Monoclonal Antibodies
Benralizumab for COPD (RESOLUTE Trial)
Phase 3
Recruiting
Led By Gerard Criner, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 40 to 85 years
History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and FEV1 ≤65% of predicted normal value
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum of 1 year and average of 2 years
Awards & highlights
RESOLUTE Trial Summary
This trial will evaluate the efficacy and safety of benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils.
Who is the study for?
Adults aged 40-85 with moderate to very severe COPD, a history of frequent exacerbations despite ongoing triple therapy, and elevated blood eosinophils can join. They must have smoked at least 10 pack-years. Excluded are those with unstable disorders, other significant lung diseases like asthma, oxygen needs over 4 L/min, certain liver diseases or infections, recent use of certain drugs or biologics.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of Benralizumab compared to a placebo in patients with COPD who frequently experience flare-ups. Participants will receive treatment for at least 56 weeks to see if it reduces these exacerbations.See study design
What are the potential side effects?
Potential side effects include common cold symptoms, headache, sore throat and reactions at the injection site such as pain or swelling. There may also be risks related to allergic reactions including anaphylaxis.
RESOLUTE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 85 years old.
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I have COPD with specific breathing test results.
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I had a severe COPD flare-up while on continuous triple therapy before joining.
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I am taking a daily inhaler for COPD equivalent to or more than 250 mcg of fluticasone.
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I've had 2 or more severe COPD flare-ups needing steroids or hospital visits in the last year.
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I am a woman who cannot become pregnant because I am either sterilized or have gone through menopause.
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I have been on a double inhaled therapy including steroids for the last year.
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I have severe COPD with specific breathing test results.
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I've had 2 or more severe COPD flare-ups needing steroids or hospital visits in the last year.
Select...
I have smoked at least 10 pack-years.
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My medication doses have been stable for the last 3 months.
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I am not pregnant.
RESOLUTE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ minimum of 1 year and average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum of 1 year and average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annualized rate of moderate or severe COPD exacerbations
Secondary outcome measures
All cause and respiratory-related mortality rate
Annual rate of hospitalizations and emergency department visits combined
Annual rate of hospitalizations due to COPD
+13 moreOther outcome measures
Safety and tolerability of benralizumab in patients with moderate to very severe COPD
Side effects data
From 2016 Phase 3 trial • 220 Patients • NCT0207525516%
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
RESOLUTE 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
4,271 Previous Clinical Trials
288,612,718 Total Patients Enrolled
Gerard Criner, MDPrincipal InvestigatorTemple University School of Medicine, 3401 North Broad Street, Suite 745 PP, Philadelphia, PA 19140
9 Previous Clinical Trials
5,172 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I use LABA/LAMA because I can't tolerate ICS.I haven't taken any experimental drugs within the last 30 days or 5 half-lives.I need more than 4 liters per minute of oxygen or my oxygen levels stay below 89% even with extra oxygen.I am between 40 and 85 years old.I use a CPAP machine for sleep apnea.I regularly take medication that affects my immune system.Your CAT total score is 15 or higher at the first visit.I have COPD with specific breathing test results.I had a severe COPD flare-up while on continuous triple therapy before joining.I have had lung surgery or a procedure to reduce lung volume in the last 6 months.I have a condition that increases my eosinophil count.I am enrolled or planning to enroll in an intensive COPD rehab program.I am not scheduled for any major surgeries during the study, but minor ones are okay.I have not taken benralizumab in the last 12 months.I have a significant lung condition that is not COPD.You had a severe allergic reaction to any biologic therapy or vaccine in the past.I've been on a stable dose of antibiotics for over 9 months due to COPD exacerbations.I haven't taken any new biologic drugs recently, except for stable treatments for conditions like osteoporosis or diabetes.I have not received blood products or immunoglobulins in the last 30 days.I have not received any live vaccines in the last 30 days.Your blood has a high level of eosinophils, a type of white blood cell, both during the screening and in the past year.My flare-ups only count if I took steroids or was hospitalized, not just antibiotics.I am either male or female.I had a worm infection in the last 6 months that wasn't cured by standard treatments.I don't have any health issues that could risk my safety in the study.I have a stable chronic liver condition, including hepatitis B or C.My flare-ups were serious enough to need steroids or hospital care.I have lung problems not caused by COPD, including nodules or infections.I am taking a daily inhaler for COPD equivalent to or more than 250 mcg of fluticasone.I have heart issues related to lung disease.I have asthma, or had it as a child, or have asthma-COPD overlap.I've had 2 or more severe COPD flare-ups needing steroids or hospital visits in the last year.I am a woman who cannot become pregnant because I am either sterilized or have gone through menopause.I have been on a double inhaled therapy including steroids for the last year.You have smoked a pack of cigarettes every day for at least 10 years.I have severe COPD with specific breathing test results.My COPD worsened even though I was on stable triple therapy.I have been admitted to the hospital for at least 24 hours.Your CAT total score is 15 or higher at Visit 1.I've had 2 or more severe COPD flare-ups needing steroids or hospital visits in the last year.You have a condition that weakens your immune system, like HIV.Your liver enzymes (ALT or AST) are more than three times the normal level, as confirmed by multiple tests.You have had problems with drinking too much alcohol or using drugs in the past year, which could affect the study results.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical pre-cancer treated over a year ago.I do not have active tuberculosis or have completed treatment if recently tested positive.I have smoked at least 10 pack-years.I am either male or female.My medication doses have been stable for the last 3 months.I have been on triple therapy for COPD for at least 3 months.I am not pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Benralizumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT04053634 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the innovation behind this clinical trial?
"Since 2014, benralizumab has been the focus of clinical research. The first trial, sponsored by AstraZeneca, included 20 participants. After the successful completion of Phase 2 & 3, the drug was approved for use. As of now, there are 20 live trials in 352 cities and 42 countries."
Answered by AI
Could I join this research study?
"This clinical trial is admitting 642 people, within the ages of 40 and 85 who currently have chronic obstructive airway disease. It is important that patients also meet the following criteria: -History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and FEV1 ≤65% of predicted normal value.-Documented history of 2 or more COPD exacerbations that required treatment with systemic corticosteroids and/or hospitalization within 52 weeks prior to enrollment.-Current or former smoker with a tobacco history of ≥"
Answered by AI
What are the official opinions of Benralizumab from the FDA?
"Benralizumab falls into Phase 3 of clinical trials, meaning that there is both evidence of efficacy and extensive safety data. Therefore, our team has rated it as a 3 in terms of safety."
Answered by AI
Does this experiment exclude senior citizens?
"The age limit for this clinical trial is 85 years old. Any person who is above the age of 40 is eligible to participate."
Answered by AI
Is there extensive research on Benralizumab's effects?
"Currently, there are 20 ongoing clinical trials studying Benralizumab's efficacy with 10 of them being Phase 3 trials. Some of these research studies are taking place in Bethesda, Maryland; however, there are 1,481 total locations worldwide where these trials are active."
Answered by AI
Can more people enroll in this clinical trial?
"Yes, if you consult clinicaltrials.gov you will see that recruitment for this trial is still underway. The trial was first advertised on August 26th, 2019 and the most recent update was on October 19th, 2020. In total, the study is looking for 642 patients from 80 different enrolment sites."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
California
New York
Other
How old are they?
65+
18 - 65
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
Better medication to treat it. looking for new therapies for copd. Looking forward to trying your recommendations as it slows me down.
PatientReceived no prior treatments
I've tried three or more medications in the past and it did not work thanks I appreciate it.
PatientReceived no prior treatments
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