Benralizumab for COPD
(RESOLUTE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests benralizumab, an injectable medication, to determine its effectiveness for individuals with moderate to very severe COPD who frequently experience flare-ups despite strong inhaler treatments. The trial targets those with elevated levels of eosinophils, a type of white blood cell that can cause lung inflammation. It suits individuals who have experienced at least two COPD flare-ups requiring treatment in the past year, even while on triple inhaler therapy. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify that you need to stop taking your current medications. In fact, it requires that you continue your existing COPD treatment (triple therapy) for at least 3 months before joining the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have tested benralizumab in patients with COPD, a lung disease that makes breathing difficult. Research has shown that benralizumab is generally well-tolerated, meaning most people can use it without serious problems. Serious side effects were uncommon, with some individuals experiencing mild headaches or sore throats.
Benralizumab is already used for other conditions, such as asthma, so doctors have some experience with its safety. However, every medicine can have side effects, and reactions can vary from person to person.
Prospective trial participants should consult a healthcare professional to understand the possible risks and benefits.12345Why do researchers think this study treatment might be promising for COPD?
Benralizumab is unique because it targets a specific part of the immune system called the interleukin-5 receptor, which plays a key role in inflammation associated with COPD. Unlike standard treatments for COPD, which often include bronchodilators and corticosteroids, Benralizumab works by reducing eosinophils, a type of white blood cell that contributes to lung inflammation. This targeted approach could lead to more effective control of symptoms and potentially fewer side effects. Researchers are excited about Benralizumab because it offers a novel mechanism that may improve lung function and quality of life for patients with COPD.
What evidence suggests that benralizumab might be an effective treatment for COPD?
Research has shown that benralizumab, which participants in this trial may receive, can help reduce asthma flare-ups, particularly in patients with high levels of eosinophils, a type of white blood cell. Although one large study did not find it significantly effective for COPD, other evidence suggests it might help with flare-ups related to eosinophils in both asthma and COPD. This treatment targets and reduces eosinophils, which are linked to inflammation and flare-ups in these conditions. Previous research found that benralizumab sometimes worked better than standard care for these flare-ups. Overall, its success in asthma offers hope for potential benefits in COPD patients with similar blood markers.12467
Who Is on the Research Team?
Gerard Criner, MD
Principal Investigator
Temple University School of Medicine, 3401 North Broad Street, Suite 745 PP, Philadelphia, PA 19140
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive benralizumab or placebo subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term safety and efficacy outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Benralizumab
- Placebo
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Administrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks
Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks
Benralizumab is already approved in European Union, United States, Canada, Japan for the following indications:
- Severe eosinophilic asthma
- Severe asthma with an eosinophilic phenotype
- Severe eosinophilic asthma
- Severe eosinophilic asthma
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Published Research Related to This Trial
Citations
Real-World Effectiveness of Benralizumab Among Patients ...
Benralizumab has proven to be effective in significantly reducing the rate of asthma exacerbations among patients with asthma in both clinical trials and real- ...
2.
astrazeneca-us.com
astrazeneca-us.com/media/press-releases/2025/Update-on-the-RESOLUTE-Phase-III-trial-for-FASENRA-in-chronic-obstructive-pulmonary-disease.htmlUpdate on the RESOLUTE Phase III trial for FASENRA in ...
The RESOLUTE Phase III trial of AstraZeneca's did not achieve statistical significance in the primary endpoint in patients with chronic ...
NCT04053634 | Efficacy and Safety of Benralizumab in ...
Phase 3 study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations.
Treating eosinophilic exacerbations of asthma and COPD ...
Benralizumab can be used as a treatment of acute eosinophilic exacerbations and achieves better outcomes than the current standard of care with ...
Benralizumab for the Prevention of COPD Exacerbations
In our trials, adverse events and serious adverse events were balanced across the treatment groups, and all-cause mortality was less than 4% ...
Benralizumab for chronic obstructive pulmonary disease and ...
Exploratory endpoints were rate of acute exacerbations by maintenance treatment, time to first acute exacerbation, change from baseline in FEV1 ...
7.
pulmonologyadvisor.com
pulmonologyadvisor.com/news/benralizumab-misses-primary-endpoint-in-copd-trial/Benralizumab Misses Primary Endpoint in COPD Trial
A phase 3 trial evaluating benralizumab for the treatment of COPD did not meet its primary endpoint, according to AstraZeneca.
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