AsthmaPhase 3GRECONCT02918071
Study to Assess Functionality, Reliability, and Performance of a Single-Use Auto-Injector With Benralizumab Administered at Home
A Phase 3 study testing Benralizumab in people with Asthma, run by AstraZeneca at 25 sites in 2 countries.
Trial summary
The purpose of the study is to assess functionality, performance, and reliability of an single-use auto-injector (AI) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or caregiver, and to confirm the safety and clinical benefit of benralizumab administration in asthma… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Benralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 10 Nov 2016to 21 Aug 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union (EU) guidelines
- Male and female patients aged 18 to 75 years of age at the time of Visit 1
- Patient or caregiver must be willing and able to self-administer the Investigational product (IP). Caregiver must be age of consent or older at the time of Visit 1, if applicable
- Weight of ≥40 kg
- Evidence of asthma as documented by airway reversibility (FEV1 ≥12% and 200 ml) demonstrated at Visit 1 or 1A or Visit 2
- Documented history of current treatment with Inhaled corticosteroids (ICS) and Long-acting β2 agonists (LABA). The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, both the mid- and high-strength maintenance doses approved in the local country will meet this ICS criterion. Additional asthma controller medications (e.g., Leukotriene receptor antagonists (LTRAs), tiotropium, theophylline, oral corticosteroids) are allowed
- Pre-bronchodilator (pre-BD) FEV1 of >50% predicted normal at Visit 1 or 1A or Visit 2
- Not well controlled asthma as documented by either: An Asthma Control Questionnaire 6 (ACQ6 ) ≥1.5 OR; A peak flow of 60-80% predicted OR; One or more exacerbation that required oral or systemic corticosteroids in the previous year
Who cannot join
- Clinically important pulmonary disease other than asthma (eg, active lung infection, COPD (Chronic obstructive pulmonary disease), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome)
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: Affect the safety of the patient throughout the study; Influence the findings of the studies or their interpretations; Impede the patient's ability to complete the entire duration of study
- Known history of allergy or reaction to the IP formulation
- History of anaphylaxis to any biologic therapy
- History of Guillain-Barré syndrome
- A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening
- Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States14 sites
Research Site
Albany, Georgia, 31707
Research Site
Boerne, Texas, 78006
Research Site
Canton, Ohio, 44718
Research Site
Edmond, Oklahoma, 73034
Research Site
McKinney, Texas, 75071
Research Site
Miami, Florida, 33126
Research Site
Minneapolis, Minnesota, 55402
Research Site
Northridge, California, 91324
Research Site
Plano, Texas, 75093
Research Site
Riverside, California, 92506
Research Site
San Antonio, Texas, 78229
Research Site
St Louis, Missouri, 63141
Research Site
Westminster, California, 92683
Research Site
Winter Park, Florida, 32789-4681
Canada11 sites
Research Site
Ajax, Ontario, L1S 2J5
Research Site
Burlington, Ontario, L7N 3V2
Research Site
Kanata, Ontario, K2L 3C8
Research Site
Mississauga, Ontario, L5A 3V4
Research Site
Montreal, Quebec, H3G 1L5
Research Site
Montreal, Quebec, H4J 1C5
Research Site
Québec, Quebec, G1G 3Y8
Research Site
Québec, Quebec, G1V 4W2
Research Site
Sherbrooke, Quebec, J1H 5N4
Research Site
Sherwood Park, Alberta, T8L 0N2
Research Site
Trois-Rivières, Quebec, G8T 7A1
About this study
Official title: A Multicenter, Open-Label, Functionality, Reliability and Performance Study of a Single-Use Auto-Injector With Home-administered Subcutaneous Benralizumab in Adult Patients With Severe Asthma (GRECO)
The purpose of the study is to assess functionality, performance, and reliability of an single-use auto-injector (AI) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or caregiver, and to confirm the safety and clinical benefit of benralizumab administration in asthma patients with severe asthma
- Conditions
- Asthma
- Being tested
- Benralizumab
- Keywords
- Asthma,, Bronchial Diseases,, Respiratory Tract Diseases,, Lung Diseases,, Obstructive Lung Diseases,, Benralizumab
- Medical subject headings
- Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabBiological
Benralizumab administered subcutaneously every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm Benralizumab | Experimental | Benralizumab administered subcutaneously every 4 weeks Receives: Biological: Benralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an AI Device at Home
Patients who are still in the study is defined as patients who had been treated for the specified timepoint. A successful administration is defined as an injection completed, an answer of "Yes" to all 5 questions in the Questionnaire, and adequately passed the visual inspection and function tests.
Measured: Week 12, Week 16, Week 12 and 16
Number of Returned AI Devices Used to Administer Benralizumab at Home That Have Been Evaluated as Functional
AI evaluated as functional is defined as the device having adequately passed the visual inspection and function tests.
Measured: Week 12, Week 16
Number of AI Devices Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)
Number (%) of AI used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on AI dispensed for patients who were treated for the specific time point. This excludes AIs dispensed but never used for the treatment or the device not returned for evaluation.
Measured: Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16
Secondary outcomes (4)
Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score
The effect of benralizumab on asthma control metrics in terms of change from baseline in mean Asthma Control Questionnaire-6 (ACQ-6) score. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations, and rescue medication. Baseline is defined as the last non-missing observation prior to the first dose of study treatment. ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Smaller score indicates better controlled asthma.
Measured: Week 0 (baseline) and weeks 4, 8, 12, 16, 20
The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab
Mean PK Concentration at each visit
Measured: Baseline, Week 8, Week 20, and Week 28
The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels
Blood eosinophil counts by timepoint
Measured: Baseline, Week 20, and Week 28
The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA)
Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive
Measured: Baseline until Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start10 Nov 2016
- Primary completion21 Aug 2017
- Study completion21 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary T. Ferguson, MD, PC, Principal investigator, Pulmonary Research Institute of Southeast Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918071
- Sponsor's protocol ID
- D3250C00031
- Acronym
- GRECO
- Status last verified
- Oct 2018
- First submitted
- 27 Sep 2016
- Last updated
- 2 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Functionality, Reliability and Performance Study of a Single-Use Auto-Injector With Home-administered Subcutaneous Benralizumab in Adult Patients With Severe Asthma (GRECO)
- ClinicalTrials.gov ID
- NCT02918071
- Acronym / sponsor ID
- GRECO / D3250C00031
- Conditions
- Asthma
- Keywords
- Asthma,, Bronchial Diseases,, Respiratory Tract Diseases,, Lung Diseases,, Obstructive Lung Diseases,, Benralizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 21 Aug 2017 (actual)
- Study completion
- 21 Aug 2017 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Posted 2 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess functionality, performance, and reliability of an single-use auto-injector (AI) with benralizumab administered subcutaneously (SC) in an at-home setting reported by the patient or caregiver, and to confirm the safety and clinical benefit of benralizumab administration in asthma patients with severe asthma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm Benralizumab | Experimental | Biological: BenralizumabBenralizumab administered subcutaneously every 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union (EU) guidelines
- Male and female patients aged 18 to 75 years of age at the time of Visit 1
- Patient or caregiver must be willing and able to self-administer the Investigational product (IP). Caregiver must be age of consent or older at the time of Visit 1, if applicable
- Weight of ≥40 kg
- Evidence of asthma as documented by airway reversibility (FEV1 ≥12% and 200 ml) demonstrated at Visit 1 or 1A or Visit 2
Key exclusion criteria (8 listed)
- Clinically important pulmonary disease other than asthma (eg, active lung infection, COPD (Chronic obstructive pulmonary disease), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome)
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: Affect the safety of the patient throughout the study; Influence the findings of the studies or their interpretations; Impede the patient's ability to complete the entire duration of study
- Known history of allergy or reaction to the IP formulation
- History of anaphylaxis to any biologic therapy
- History of Guillain-Barré syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenralizumabBenralizumab administered subcutaneously every 4 weeks | Biological | Arm Benralizumab |
Primary outcome
Number of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an AI Device at Home
Time frame: Week 12, Week 16, Week 12 and 16
Patients who are still in the study is defined as patients who had been treated for the specified timepoint. A successful administration is defined as an injection completed, an answer of "Yes" to all 5 questions in the Questionnaire, and adequately passed the visual inspection and function tests.
Number of Returned AI Devices Used to Administer Benralizumab at Home That Have Been Evaluated as Functional
Time frame: Week 12, Week 16
AI evaluated as functional is defined as the device having adequately passed the visual inspection and function tests.
Number of AI Devices Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)
Time frame: Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16
Number (%) of AI used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on AI dispensed for patients who were treated for the specific time point. This excludes AIs dispensed but never used for the treatment or the device not returned for evaluation.
4 secondary outcomes
Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score
Time frame: Week 0 (baseline) and weeks 4, 8, 12, 16, 20
The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab
Time frame: Baseline, Week 8, Week 20, and Week 28
The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels
Time frame: Baseline, Week 20, and Week 28
The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA)
Time frame: Baseline until Week 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary T. Ferguson, MD, PC principal investigator
Pulmonary Research Institute of Southeast Michigan
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benralizumab in people with Asthma, run by AstraZeneca at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an AI Device at Home (time frame: Week 12, Week 16, Week 12 and 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.