Asthma AttackPhase 2NCT04617171
Benralizumab Initiated During Severe Asthma Attack
A Phase 2 study testing Benralizumab 30 MG/ML [Fasenra] in people with Asthma Attack and Asthma, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Approximately 300 million people have asthma worldwide and 400,000 people died from asthma globally in 2015 (GINA Asthma). Singapore's asthma mortality and hospitalisation rates are several times higher than OECD countries. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Asthma Attack, Asthma
- What is being tested?
- Benralizumab 30 MG/ML [Fasenra]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Jun 2021to Aug 2023
- Phase
- Phase 2
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with severe asthma exacerbation requiring hospital admission
- Subjects aged 21 to 65 years with a physician diagnosis of asthma for greater than or equal to 1 year
- Subjects with 2 or more exacerbations in the past 12 months
- On maintenance of medium to high dose ICS/LABA (GINA Step 4 and 5) for at least 6 months
- Blood Eosinophil count of ≥ 150 cells/microL at time of admission or ≥ 300 cells/microL documented over the past 52 weeks
- Informed consent obtained
Who cannot join
- Subjects with asthma exacerbations who are treated and then discharged from ED within 24 hours
- Subjects with a physician diagnosis of COPD, bronchiectasis
- Smokers > 20 pack years
- Anaphylactic/anaphylactoid reaction presenting with bronchospasm
- Other known causes of eosinophilia besides asthma (e.g. parasitic infection)
- Subjects who are deemed by investigators to have with life expectancy of < 12 months (any cause)
Show all 12Show fewer
- Subjects who are already on investigational drug or has been participating in another clinical study with an investigational product during the last 6 months
- Female subjects who are pregnant or planning pregnancy. All subjects should refrain from family planning during and 4 months following the last dose. Male subjects should refrain from fathering a child or donating sperm during the study and 4 months following the last dose
- Subjects with known history of allergy or reaction to any component of the investigational product formation
- Subjects with history of primary immunodeficiency
- Subjects who have received Xolair (anti-IgE mAb) within 4 months before randomization
- Subjects who receive immunoglobulin or blood products within 30 days before randomization
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, Foreign, 169856
Mariko Koh, MBBS, 63214700, mariko.koh.s.y@singhealth.com.sg
About this study
Official title: Randomized Double Blind Placebo Controlled Trial of Benralizumab, an Antiinterleukin 5 Receptor α Monoclonal Antibody, Initiated During Hospitalization for Severe Asthma Attack in Reducing Severe Exacerbations: Phase 2B Study
Approximately 300 million people have asthma worldwide and 400,000 people died from asthma globally in 2015 (GINA Asthma). Singapore's asthma mortality and hospitalisation rates are several times higher than OECD countries. Spot Blood eosinophil count (BEC) during an acute exacerbation of asthma was a predictor of more severe respiratory failure and was associated with future acute health care utilization (HR 1.8, 95% CI 1.1-2.9, p=0.02) in a previous study conducted across 4 ICUs in Singapore. Benralizumab, an anti-IL5 receptor α monoclonal antibody causes rapid depletion of blood eosinophils and reduces asthma exacerbations when given over 12-month duration in patient with Severe Eosinophilic Asthma. However, the efficacy of Benralizumab when given during an acute exacerbation of asthma in reducing future exacerbations or severity of asthma exacerbation is relatively unexplored. A Phase 2A randomized double-blind placebo-controlled trial involving the use of one dose of the intravenous formulation of Benralizumab (0.3 mg/kg or 1.0mg/kg) in patients presenting with acute asthma exacerbation did not demonstrate difference in the proportion of subjects with >/=1 asthma exacerbation at 12 weeks when compared to placebo (33.3% vs. 38.9%; P=0.67). However, compared with placebo, Benralizumab reduced asthma exacerbation rates by 49% (3.59 vs 1.82; P=0.01) and exacerbations resulting in hospitalization by 60% (1.62 vs 0.65; P=.02) in the combined groups at 12 weeks (secondary outcomes).
Benralizumab, an anti-IL5 receptor α monoclonal antibody causes rapid depletion of blood eosinophils and reduces asthma exacerbations when given over 12-month duration in patient with Severe Eosinophilic Asthma.
Read more
This study aims to look at whether subcutaneous administration of Benralizumab when initiated during an acute severe asthma exacerbation and then continued over 48 weeks period can increase time to first exacerbation compared to placebo as well as other key secondary outcome such as hospital readmission and health care utilization.
We hypothesise that administration of Benralizumab when initiated during an acute severe asthma exacerbation and then continued over 48 weeks period can increase time to first exacerbation compared to placebo as well as other key secondary outcome such as hospital readmission and health care utilization.
Read the detailed description
The efficacy of Benralizumab when given during an acute exacerbation of asthma in reducing future exacerbations or severity of asthma exacerbation is relatively unexplored. A Phase 2A randomized double-blind placebo-controlled trial involving the use of one dose of the intravenous formulation of Benralizumab (0.3 mg/kg or 1.0mg/kg) in patients presenting with acute asthma exacerbation did not demonstrate difference in the proportion of subjects with >/=1 asthma exacerbation at 12 weeks when compared to placebo (33.3% vs. 38.9%; P=0.67). However, compared with placebo, Benralizumab reduced asthma exacerbation rates by 49% (3.59 vs 1.82; P=0.01) and exacerbations resulting in hospitalization by 60% (1.62 vs 0.65; P=.02) in the combined groups at 12 weeks (secondary outcomes).
The purpose of this study is to look at whether Benralizumab, an anti-IL5 receptor α monoclonal antibody given subcutaneously compared to placebo given subcutaneously, can increase time to first exacerbation, reduce health care utilisation and improve other asthma outcomes in patients presenting with acute severe asthma exacerbation requiring hospitalisation. Randomized double-blind placebo-controlled trial design was chosen to reduce selection bias by randomisation and concealment of allocation, reduce analysis or interobserver ascertainment bias by blinding, and reduce bias introduced by exclusion after randomisation by using Intention- to-treat (ITT) analysis. In addition, biomarker stratified approach using spot BEC < or >/= 300 cells/microL during an acute exacerbation will be used to evaluate its role as a predictive biomarker for response to Benralizumab.
The study aims to recruit 128 patients over a 2-year period at Singapore General Hospital and Changi General Hospital.
- Conditions
- Asthma Attack, Asthma
- Being tested
- Benralizumab 30 MG/ML [Fasenra], Placebos
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benralizumab 30 MG/ML [Fasenra]Drug
Also called Fasenra
Benralizumab/placebo initiated at an acute severe asthma exacerbation, then continued over a period of 48 weeks
PlacebosDrug
Also called Placebo
Benralizumab/placebo initiated at an acute severe asthma exacerbation, then continued over a period of 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab | Experimental | Benralizumab 30 mg given in the form of subcutaneous injection every 4 weeks for the first three doses, then every 8 weeks subsequently up till Week 48. Receives: Drug: Benralizumab 30 MG/ML [Fasenra] |
| Placebo | Placebo comparator | Normal Saline given subcutaneously every 4 weeks for the first three doses, then every 8 weeks subsequently up till Week 48. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first exacerbation in patients with a severe asthma exacerbation with raised blood eosinophil count
Time to first exacerbation requiring either oral corticosteroid (OCS) use and/or an unscheduled visit to the Emergency Department or hospitalization
Measured: Change from baseline (Day 1) to 52 weeks
Secondary outcomes (12)
Time to hospital readmission due to asthma exacerbation (Key Secondary outcome)
Time to hospital readmission due to asthma exacerbation
Measured: Baseline (Day 1) to 52 weeks
Rate of severe exacerbation (i.e. requiring admission to hospital for asthma exacerbation)
NUmber of severe exacerbation (i.e. requiring admission to hospital for asthma exacerbation)
Measured: Baseline (Day 1) to 52 weeks
Hospital LOS (index admission and subsequent admissions)
Total hospital LOS
Measured: Change from baseline (Day 1) to 52 weeks
Need for Intensive Care Unit (ICU) admission with/without mechanical ventilation during the index admission
ICU admission during index admission
Measured: Baseline (Day 1) to index admission discharge date
Hospital survival post admission (index admission)
Hospital survival for index admission
Measured: Baseline (Day 1) to index admission discharge date
Total OCS burden
Cumulative OCS dose
Measured: Baseline (Day 1) to 52 weeks
Total number of exacerbations requiring emergency healthcare utilization (including ED, polyclinic visits, Specialist outpatient visits)
Total number of emergency healthcare utilization for exacerbations
Measured: Baseline (Day 1) to 52 weeks
Pre/post bronchodilator Forced Expiratory Volume 1s (FEV1), FVC, FEV1/FVC at baseline and at 52 weeks
Change in Pre/post bronchodilator Forced Expiratory Volume 1s (FEV1), FVC, FEV1/FVC
Measured: Change from baseline (Day 1) to 52 weeks
Blood eosinophil counts (serial measurement over 52 weeks)
Change in blood eosinophils
Measured: Change from baseline (Day 1) to 52 weeks
GINA assessment of symptom control
Change in GINA assessment of symptom control ( Well controlled, Partly controlled or Uncontrolled)
Measured: Change from baseline (Day 1) to 52 weeks
Asthma Control Questionnaire 7 (ACQ 7)
Change in Asthma Control Questionnaire 7 (ACQ 7) Scores range from 0-6( higher is worse). A score of 0.0-0.75 is classified as well-controlled asthma; 0.75-1.5 is a grey zone; and >1.5 is poorly controlled asthma. The minimum clinically important difference is 0.5
Measured: Change from baseline (Day 1) to 52 weeks
St George's Respiratory Questionnaire (SGRQ)
Change in St George's Respiratory Questionnaire (SGRQ) The SGRQ total score is made up of 2 parts : Part 1 addresses the frequency of respiratory symptoms and Part 2 addresses the patient's current state. Data is entered into the calculator and scores will be generated ( 0 to 100). The lower the score, the better.
Measured: Change from baseline (Day 1) to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start2 Jun 2021
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Asthma AttackStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariko Koh, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617171
- Sponsor's protocol ID
- FASTER
- Status last verified
- Jul 2021
- First submitted
- 26 Jun 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yii ACA, Tay TR, Puah SH, Lim HF, Li A, Lau P, Tan R, Neo LP, Chung KF, Koh MS. Blood eosinophil count correlates with severity of respiratory failure in life-threatening asthma and predicts risk of subsequent exacerbations. Clin Exp Allergy. 2019 Dec;49(12):1578-1586. doi: 10.1111/cea.13465. Epub 2019 Aug 6.
PubMed 31310686Nowak RM, Parker JM, Silverman RA, Rowe BH, Smithline H, Khan F, Fiening JP, Kim K, Molfino NA. A randomized trial of benralizumab, an antiinterleukin 5 receptor alpha monoclonal antibody, after acute asthma. Am J Emerg Med. 2015 Jan;33(1):14-20. doi: 10.1016/j.ajem.2014.09.036. Epub 2014 Oct 5.
PubMed 25445859Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, Sproule S, Gilmartin G, Aurivillius M, Werkstrom V, Goldman M; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-2127. doi: 10.1016/S0140-6736(16)31324-1. Epub 2016 Sep 5.
PubMed 27609408FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, Lommatzsch M, Ferguson GT, Busse WW, Barker P, Sproule S, Gilmartin G, Werkstrom V, Aurivillius M, Goldman M; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor alpha monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2128-2141. doi: 10.1016/S0140-6736(16)31322-8. Epub 2016 Sep 5.
PubMed 27609406
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Placebo Controlled Trial of Benralizumab, an Antiinterleukin 5 Receptor α Monoclonal Antibody, Initiated During Hospitalization for Severe Asthma Attack in Reducing Severe Exacerbations: Phase 2B Study
- ClinicalTrials.gov ID
- NCT04617171
- Acronym / sponsor ID
- FASTER
- Conditions
- Asthma Attack, Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 5 Nov 2020 (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.
Approximately 300 million people have asthma worldwide and 400,000 people died from asthma globally in 2015 (GINA Asthma). Singapore's asthma mortality and hospitalisation rates are several times higher than OECD countries. Spot Blood eosinophil count (BEC) during an acute exacerbation of asthma was a predictor of more severe respiratory failure and was associated with future acute health care utilization (HR 1.8, 95% CI 1.1-2.9, p=0.02) in a previous study conducted across 4 ICUs in Singapore. Benralizumab, an anti-IL5 receptor α monoclonal antibody causes rapid depletion of blood eosinophils and reduces asthma exacerbations when given over 12-month duration in patient with Severe Eosinophilic Asthma. However, the efficacy of Benralizumab when given during an acute exacerbation of asthma in reducing future exacerbations or severity of asthma exacerbation is relatively unexplored. A Phase 2A randomized double-blind placebo-controlled trial involving the use of one dose of the intravenous formulation of Benralizumab (0.3 mg/kg or 1.0mg/kg) in patients presenting with acute asthma exacerbation did not demonstrate difference in the proportion of subjects with >/=1 asthma exacerbation at 12 weeks when compared to placebo (33.3% vs. 38.9%; P=0.67). However, compared with placebo, Benralizumab reduced asthma exacerbation rates by 49% (3.59 vs 1.82; P=0.01) and exacerbations resulting in hospitalization by 60% (1.62 vs 0.65; P=.02) in the combined groups at 12 weeks (secondary outcomes).
Benralizumab, an anti-IL5 receptor α monoclonal antibody causes rapid depletion of blood eosinophils and reduces asthma exacerbations when given over 12-month duration in patient with Severe Eosinophilic Asthma.
This study aims to look at whether subcutaneous administration of Benralizumab when initiated during an acute severe asthma exacerbation and then continued over 48 weeks period can increase time to first exacerbation compared to placebo as well as other key secondary outcome such as hospital readmission and health care utilization.
We hypothesise that administration of Benralizumab when initiated during an acute severe asthma exacerbation and then continued over 48 weeks period can increase time to first exacerbation compared to placebo as well as other key secondary outcome such as hospital readmission and health care utilization.
Detailed description
The efficacy of Benralizumab when given during an acute exacerbation of asthma in reducing future exacerbations or severity of asthma exacerbation is relatively unexplored. A Phase 2A randomized double-blind placebo-controlled trial involving the use of one dose of the intravenous formulation of Benralizumab (0.3 mg/kg or 1.0mg/kg) in patients presenting with acute asthma exacerbation did not demonstrate difference in the proportion of subjects with >/=1 asthma exacerbation at 12 weeks when compared to placebo (33.3% vs. 38.9%; P=0.67). However, compared with placebo, Benralizumab reduced asthma exacerbation rates by 49% (3.59 vs 1.82; P=0.01) and exacerbations resulting in hospitalization by 60% (1.62 vs 0.65; P=.02) in the combined groups at 12 weeks (secondary outcomes).
The purpose of this study is to look at whether Benralizumab, an anti-IL5 receptor α monoclonal antibody given subcutaneously compared to placebo given subcutaneously, can increase time to first exacerbation, reduce health care utilisation and improve other asthma outcomes in patients presenting with acute severe asthma exacerbation requiring hospitalisation. Randomized double-blind placebo-controlled trial design was chosen to reduce selection bias by randomisation and concealment of allocation, reduce analysis or interobserver ascertainment bias by blinding, and reduce bias introduced by exclusion after randomisation by using Intention- to-treat (ITT) analysis. In addition, biomarker stratified approach using spot BEC < or >/= 300 cells/microL during an acute exacerbation will be used to evaluate its role as a predictive biomarker for response to Benralizumab.
The study aims to recruit 128 patients over a 2-year period at Singapore General Hospital and Changi General Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benralizumab | Experimental | Drug: Benralizumab 30 MG/ML [Fasenra]Benralizumab 30 mg given in the form of subcutaneous injection every 4 weeks for the first three doses, then every 8 weeks subsequently up till Week 48. |
| Placebo | Placebo comparator | Drug: PlacebosNormal Saline given subcutaneously every 4 weeks for the first three doses, then every 8 weeks subsequently up till Week 48. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with severe asthma exacerbation requiring hospital admission
- Subjects aged 21 to 65 years with a physician diagnosis of asthma for greater than or equal to 1 year
- Subjects with 2 or more exacerbations in the past 12 months
- On maintenance of medium to high dose ICS/LABA (GINA Step 4 and 5) for at least 6 months
- Blood Eosinophil count of ≥ 150 cells/microL at time of admission or ≥ 300 cells/microL documented over the past 52 weeks
Key exclusion criteria (12 listed)
- Subjects with asthma exacerbations who are treated and then discharged from ED within 24 hours
- Subjects with a physician diagnosis of COPD, bronchiectasis
- Smokers > 20 pack years
- Anaphylactic/anaphylactoid reaction presenting with bronchospasm
- Other known causes of eosinophilia besides asthma (e.g. parasitic infection)
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 |
|---|---|---|
| Benralizumab 30 MG/ML [Fasenra]Also: FasenraBenralizumab/placebo initiated at an acute severe asthma exacerbation, then continued over a period of 48 weeks | Drug | Benralizumab |
| PlacebosAlso: PlaceboBenralizumab/placebo initiated at an acute severe asthma exacerbation, then continued over a period of 48 weeks | Drug | Placebo |
Primary outcome
Time to first exacerbation in patients with a severe asthma exacerbation with raised blood eosinophil count
Time frame: Change from baseline (Day 1) to 52 weeks
Time to first exacerbation requiring either oral corticosteroid (OCS) use and/or an unscheduled visit to the Emergency Department or hospitalization
12 secondary outcomes
Time to hospital readmission due to asthma exacerbation (Key Secondary outcome)
Time frame: Baseline (Day 1) to 52 weeks
Rate of severe exacerbation (i.e. requiring admission to hospital for asthma exacerbation)
Time frame: Baseline (Day 1) to 52 weeks
Hospital LOS (index admission and subsequent admissions)
Time frame: Change from baseline (Day 1) to 52 weeks
Need for Intensive Care Unit (ICU) admission with/without mechanical ventilation during the index admission
Time frame: Baseline (Day 1) to index admission discharge date
Hospital survival post admission (index admission)
Time frame: Baseline (Day 1) to index admission discharge date
Total OCS burden
Time frame: Baseline (Day 1) to 52 weeks
Total number of exacerbations requiring emergency healthcare utilization (including ED, polyclinic visits, Specialist outpatient visits)
Time frame: Baseline (Day 1) to 52 weeks
Pre/post bronchodilator Forced Expiratory Volume 1s (FEV1), FVC, FEV1/FVC at baseline and at 52 weeks
Time frame: Change from baseline (Day 1) to 52 weeks
Blood eosinophil counts (serial measurement over 52 weeks)
Time frame: Change from baseline (Day 1) to 52 weeks
GINA assessment of symptom control
Time frame: Change from baseline (Day 1) to 52 weeks
Asthma Control Questionnaire 7 (ACQ 7)
Time frame: Change from baseline (Day 1) to 52 weeks
St George's Respiratory Questionnaire (SGRQ)
Time frame: Change from baseline (Day 1) to 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Results publication: PubMed 31310686Yii ACA, Tay TR, Puah SH, Lim HF, Li A, Lau P, Tan R, Neo LP, Chung KF, Koh MS. Blood eosinophil count correlates with severity of respiratory failure in life-threatening asthma and predicts risk of subsequent exacerbations. Clin Exp Allergy. 2019 Dec;49(12):1578-1586. doi: 10.1111/cea.13465. Epub 2019 Aug 6.
- Results publication: PubMed 25445859Nowak RM, Parker JM, Silverman RA, Rowe BH, Smithline H, Khan F, Fiening JP, Kim K, Molfino NA. A randomized trial of benralizumab, an antiinterleukin 5 receptor alpha monoclonal antibody, after acute asthma. Am J Emerg Med. 2015 Jan;33(1):14-20. doi: 10.1016/j.ajem.2014.09.036. Epub 2014 Oct 5.
- Results publication: PubMed 27609408Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, Sproule S, Gilmartin G, Aurivillius M, Werkstrom V, Goldman M; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-2127. doi: 10.1016/S0140-6736(16)31324-1. Epub 2016 Sep 5.
- Results publication: PubMed 27609406FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, Lommatzsch M, Ferguson GT, Busse WW, Barker P, Sproule S, Gilmartin G, Werkstrom V, Aurivillius M, Goldman M; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor alpha monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2128-2141. doi: 10.1016/S0140-6736(16)31322-8. Epub 2016 Sep 5.
- 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.
Mariko Koh principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Benralizumab 30 MG/ML [Fasenra] in people with Asthma Attack and Asthma, run by Singapore General Hospital at 1 site in Singapore.
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 6 inclusion and 12 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 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mariko Koh (62223322, mariko.koh.s.y@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first exacerbation in patients with a severe asthma exacerbation with raised blood eosinophil count (time frame: Change from baseline (Day 1) to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04617171, which also lists 4 linked publications.
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 23 Jul 2021.