Asthma, Exercise-InducedPhase 3NCT03327701
The Effect of Benralizumab on Exercise-induced Bronchoconstriction
A Phase 3 study testing Benralizumab in people with Asthma, Exercise-Induced, run by Louis-Philippe Boulet.
Trial summary
Severe asthma affects 5-10% of more than 300 million asthmatics. Ten to twenty percent of individuals suffering from asthma do not respond well to current treatment due to the complexity of the different mechanisms underlying asthma pathogenesis, and sometimes due to an insufficient effect of treatment on underlying… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Exercise-Induced
- What is being tested?
- Benralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Apr 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent for study participants must be obtained prior to any study related procedures being performed and according to local guidelines;
- Asthma diagnosis according to current guidelines;
- General good health as declared by the investigator;
- Respiratory symptoms such as wheeze, shortness of breath, chest tightness or cough during physical activity;
- Moderate to severe eosinophilic asthma (Inhaled corticosteroids, 250 mcg/day fluticasone equivalent or more and long acting beta2-agonists, stable for at least one month);
- Sufficient adherence to maintenance therapy (from questionnaire and pharmacy reports: adherence to at least 80% of medication prescribed on both);
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- Baseline blood eosinophil counts of at least 300 cells/ul and/or sputum eosinophil of at least 3%;
- Exercise less than 4 hours per week and remain stable through the study;
- Presence of EIB: A post-exercise fall in FEV1 of at least 10% from baseline;
- Pre-bronchodilator FEV1 at screening of at least 70% of the predicted value;
- Women of childbearing potential (WOCBP) must use an effective form of birth control (confirmed by the investigator). Effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device/levonorgestrel Intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch™ or Nuvaring™. WOCBP must agree to use effective method of birth control, as defined above, from enrolment, throughout the study duration and 20 weeks after last dose of study product, and have negative serum pregnancy test result on Visit 1;
- Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply:
- Women <50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment. They also need follicle stimulating hormone (FSH) levels in the postmenopausal range.
- Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
Who cannot join
- Respiratory tract infection within 6 weeks preceding enrolment;
- Asthma exacerbation in the last month;
- Use of prednisone in the last 30 days;
- Current lung disease other than moderate to severe eosinophilic asthma;
- History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or light headedness, as judged by the investigator;
- Any history or symptoms of uncontrolled cardiovascular disease, particularly coronary artery disease, arrhythmias, hypertension, or congestive heart failure;
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- Any history or symptoms of significant neurologic disease, including transient ischemic attack (TIA), stroke, seizure disorder, or behavioural disturbances;
- Any history or symptoms of clinically significant autoimmune disease;
- Any history of clinically significant haematologic abnormality, including coagulopathy or any history of chronic treatment with anti-coagulants (e.g. warfarin, etc.) or anti-platelet agent (e.g. aspirin, etc.);
- Clinically significant abnormalities in laboratory test results at enrolment and during the screening period (including complete blood count, coagulation, chemistry panel and urinalysis) unless judged not significant by the investigator;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥2.5 times the upper limit of normal (ULN) confirmed during screening period;
- Being pregnant or lactating or have positive serum pregnancy test at enrolment or positive urine pregnancy test during the study;
- Use of nonsteroidal anti-inflammatory drugs (NSAIDs) 72 hours before or aspirin prn within 7 days of enrolment (Visit 1), as judged by the investigator;
- Current smokers. Ex-smokers must not have smoked for a minimum of 12 months, and should not have a smoking history ≥10 pack years. Subjects who administer nicotine in other forms (patches, chew tobacco, etc.) will also be excluded from the study;
- Concomitant disease or condition which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study, including, but not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease;
- History of cancer in last 5 years:
- Alcohol or drug abuse (past or present);
- Subject who is scheduled to be admitted to hospital or undergo in-subject surgery during the study;
- History of anaphylaxis to any biologic therapy or vaccine;
- 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;
- Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol;
- A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test;
- Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, oral corticosteroid, or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent is obtained;
- Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained;
- Receipt of any marketed (e.g. omalizumab) or investigational biologic within 4 months or 5 half-lives prior to randomization is obtained, whichever is longer;
- Receipt of live attenuated vaccines 30 days prior to the date of randomization
- Receipt of inactive/killed vaccinations (e.g., inactive influenza) are allowed provided they are not administered within 1 week before/after any IP administration.
- Previously received benralizumab (MEDI-563);
- AstraZeneca staff involved in planning and/or conducting the study;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Benralizumab on Lung Physiology, Exercise-induced Bronchoconstriction and General Health Status: an Exploratory Mechanistic Study
Severe asthma affects 5-10% of more than 300 million asthmatics. Ten to twenty percent of individuals suffering from asthma do not respond well to current treatment due to the complexity of the different mechanisms underlying asthma pathogenesis, and sometimes due to an insufficient effect of treatment on underlying airway inflammation. Consequently, some asthmatics have poorer quality of life due to: frequent asthma symptoms, regular medical or emergency visits, limitation in their activities of daily living, including exercise. It is believed that the benralizumab can help to reduce airway inflammation and thus improve exercise tolerance in individuals with asthma. The main objective of this study is to determine the effect of benralizumab on exercise-induced bronchoconstriction (EIB) and exercise tolerance in moderate to severe eosinophilic asthmatics, in comparison with baseline values and a placebo treatment.
Read the detailed description
Subjects will receive benralizumab every 4 weeks for three doses followed by a fourth dose 8 weeks later. On baseline and after 4, 16 and 20 weeks, subjects will be assess for airway responsiveness to exercise and exercise tolerance.
- Conditions
- Asthma, Exercise-Induced
- Being tested
- Benralizumab
- Keywords
- Exercise-induced bronchoconstriction, Benralizumab, Antiinterleukin 5 receptor α monoclonal antibody
- Medical subject headings
- Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabDrug
Subjects will receive benralizumab 30 mg (subcutaneous) every 4 weeks for three doses followed by a fourth dose 8 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Active comparator | Subjects will receive benralizumab 30 mg (subcutaneous) every 4 weeks for three doses followed by a fourth dose 8 weeks later. Receives: Drug: Benralizumab |
| Placebo | Placebo comparator | Subjects will receive placebo 30 mg (subcutaneous) every 4 weeks for three doses followed by a fourth dose 8 weeks later. Receives: Drug: Benralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post-exercise fall in expiratory flows
Maximal fall in forced expiratory volume in one second (FEV1) post-exercise challenge
Measured: Baseline and after 4, 16 and 20 weeks
Secondary outcomes (1)
Change in exercise tolerance
Endurance time on a steady-state exercise
Measured: Baseline and after 4, 16 and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study startDec 2017 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, Exercise-InducedStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a parallel study, double-blind, placebo controlled randomized trial, with a ratio placebo-active drug 1:2.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louis-Philippe Boulet
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Louis-Philippe Boulet, Laval University
- Investigators
- Louis-Philippe Boulet, MD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327701
- Sponsor's protocol ID
- CER-21525
- Status last verified
- Oct 2017
- First submitted
- 19 Oct 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Benralizumab on Lung Physiology, Exercise-induced Bronchoconstriction and General Health Status: an Exploratory Mechanistic Study
- ClinicalTrials.gov ID
- NCT03327701
- Acronym / sponsor ID
- CER-21525
- Conditions
- Asthma, Exercise-Induced
- Keywords
- Exercise-induced bronchoconstriction, Benralizumab, Antiinterleukin 5 receptor α monoclonal antibody
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Louis-Philippe BouletUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Severe asthma affects 5-10% of more than 300 million asthmatics. Ten to twenty percent of individuals suffering from asthma do not respond well to current treatment due to the complexity of the different mechanisms underlying asthma pathogenesis, and sometimes due to an insufficient effect of treatment on underlying airway inflammation. Consequently, some asthmatics have poorer quality of life due to: frequent asthma symptoms, regular medical or emergency visits, limitation in their activities of daily living, including exercise. It is believed that the benralizumab can help to reduce airway inflammation and thus improve exercise tolerance in individuals with asthma. The main objective of this study is to determine the effect of benralizumab on exercise-induced bronchoconstriction (EIB) and exercise tolerance in moderate to severe eosinophilic asthmatics, in comparison with baseline values and a placebo treatment.
Detailed description
Subjects will receive benralizumab every 4 weeks for three doses followed by a fourth dose 8 weeks later. On baseline and after 4, 16 and 20 weeks, subjects will be assess for airway responsiveness to exercise and exercise tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study is a parallel study, double-blind, placebo controlled randomized trial, with a ratio placebo-active drug 1:2.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Active comparator | Drug: BenralizumabSubjects will receive benralizumab 30 mg (subcutaneous) every 4 weeks for three doses followed by a fourth dose 8 weeks later. |
| Placebo | Placebo comparator | Drug: BenralizumabSubjects will receive placebo 30 mg (subcutaneous) every 4 weeks for three doses followed by a fourth dose 8 weeks later. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent for study participants must be obtained prior to any study related procedures being performed and according to local guidelines;
- Asthma diagnosis according to current guidelines;
- General good health as declared by the investigator;
- Respiratory symptoms such as wheeze, shortness of breath, chest tightness or cough during physical activity;
- Moderate to severe eosinophilic asthma (Inhaled corticosteroids, 250 mcg/day fluticasone equivalent or more and long acting beta2-agonists, stable for at least one month);
Key exclusion criteria (30 listed)
- Respiratory tract infection within 6 weeks preceding enrolment;
- Asthma exacerbation in the last month;
- Use of prednisone in the last 30 days;
- Current lung disease other than moderate to severe eosinophilic asthma;
- History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or light headedness, as judged by the investigator;
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 |
|---|---|---|
| BenralizumabSubjects will receive benralizumab 30 mg (subcutaneous) every 4 weeks for three doses followed by a fourth dose 8 weeks later. | Drug | Experimental, Placebo |
Primary outcome
Change in post-exercise fall in expiratory flows
Time frame: Baseline and after 4, 16 and 20 weeks
Maximal fall in forced expiratory volume in one second (FEV1) post-exercise challenge
1 secondary outcome
Change in exercise tolerance
Time frame: Baseline and after 4, 16 and 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Louis-Philippe Boulet, MD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benralizumab in people with Asthma, Exercise-Induced, run by Louis-Philippe Boulet.
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 14 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louis-Philippe Boulet, MD (418-656-4747, lpboulet@med.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in post-exercise fall in expiratory flows (time frame: Baseline and after 4, 16 and 20 weeks). 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 31 Oct 2017.