Asthma BrittleNCT03324230
Exploring Asthma Exacerbations in Mepolizumab Treated Patients
An observational study of Asthma Brittle, run by Queen's University, Belfast at 4 sites in United Kingdom.
Trial summary
This is a multicentre, observational study focusing on exacerbation events in patients with severe eosinophilic asthma on Mepolizumab. Mepolizumab is an anti-IL5 (Interleukin 5) monoclonal antibody which blocks the eosinophilic activation pathways associated with decreasing asthma control. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma Brittle
- How many people
- 146 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Dec 2017to 29 Jun 2019
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients known to Difficult Asthma services within the NHS, who are eligible for Mepolizumab treatment as per NICE guidelines.
Who may be able to join
- Age ≥ 18 and ≤ 80 years at Visit 1
- Able and willing to provide written informed consent and to comply with the study protocol including being able to contact the clinical center and to attend for assessment during a symptomatic deterioration
- Severe asthma despite confirmed after assessment by an asthma specialist
- Diagnosed with asthma at least 12 months prior to screening
Who cannot join
- Acute exacerbation requiring oral corticosteroids in 4 weeks before screening.
- Other clinically significant medical disease or uncontrolled concomitant disease despite treatment that is likely, in the opinion of the investigator, to require a change in therapy or impact the ability to participate in the study
- History of current alcohol, drug, or chemical abuse or past abuse that would impair or risk the subject's full participation in the study, in the opinion of the investigator
- Treatment with an investigational agent within 30 days of visit 1 (or 5 half-lives of the investigational agent, whichever is longer)
- Female subjects who are pregnant or lactating (excluded as candidates for Mepolizumab in clinic prior to study)
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Queen's University Belfast
Belfast, County Antrim, BT7 1NN
Gartnavel General Hospital, Greater Glasgow and Clyde NHS Trust
Glasgow, Scotland, G12 0YN
Leicester Biomedical Research Centre
Leicester, Leicestershire, LE3 9QP
Oxford University
Oxford
About this study
Official title: Exacerbation Profile in Patients on Mepolizumab for Severe Refractory Eosinophilic Asthma- an Exploratory Study.
This is a multicentre, observational study focusing on exacerbation events in patients with severe eosinophilic asthma on Mepolizumab.
Mepolizumab is an anti-IL5 (Interleukin 5) monoclonal antibody which blocks the eosinophilic activation pathways associated with decreasing asthma control. The pre-licensing studies have shown that Mepolizumab decreases asthma exacerbation events by approximately 50%, this study seeks to understand the underlying mechanisms of the remaining 50% of exacerbations.
Read more
The study will enrol patients within GINA classification 4 and 5 who are known to difficult asthma services across four UK sites. Some patients will recently have been commenced on Mepolizumab, whilst others will be commenced on the drug on entry to the study. The patients will have baseline measurements of biomarkers, lung function, sputum analysis and quality of life questionnaires on study entry, after which patients will be asked to contact the clinic at the first signs of worsening asthma symptoms to arrange a clinic visit prior to commencing rescue treatment. They will be clinically assessed with review of peak flow and symptom diaries, measurements taken at baseline will be repeated and a decision on the nature of the exacerbation and treatment required will be made.
This is an observational study, all outcomes will be exploratory.
Read the detailed description
Background:
Around 15% of the United Kingdom (UK) have asthma, of these, 10-20% have asthma which is difficult to control using current therapies and with high levels of morbidity resulting. These patients consume 50-60% of the UK healthcare costs of asthma and as such, there is much interest in developing novel treatments for this group.
The heterogeneity of inflammatory pathways underlying asthma are of great interest with development of biomarkers useful for phenotyping asthmatic patients and allowing more accurate assessment of their response to treatment. Traditionally, oral corticosteroids are used in eosinophilic 'T2-high' asthmatic patients with good therapeutic effect, however, there are a group of T2-high patients who have refractory type-2 cytokine driven inflammation and airway eosinophilia despite oral corticosteroids. As such, there are several novel biological agents being engineered to block type 2 cytokine pathways including antagonists to IL5, IL13 and IL4 (Interleukin 5, 13, 4).
Mepolizumab is a humanised monoclonal antibody against IL5. Through a selective inhibition of eosinophilic inflammation, the agent reduces the number of eosinophils in sputum and blood, with important clinical outcomes such as a reduction of asthma exacerbations and a need for systemic glucocorticoids. The pre-licencing clinical trials have shown that selective inhibition of IL5 and presumptive removal of eosinophils reduces exacerbations by 50%, but while this is a significant reduction, patients with severe asthma continue to have severe exacerbations requiring systemic corticosteroid administration.
Therefore, the point of interest is eliciting the inflammatory phenotype and physiological characteristics of the remaining 50% of exacerbations and ascertaining whether systemic corticosteroids have a role when the IL-5 pathway has been blocked by Mepolizumab.
Purpose/ Aim This is an observational study designed to phenotype exacerbations or worsening asthma control when participants are established on Mepolizumab. The study will look for changes in lung function, biomarkers and patient symptoms scores.
The hypothesis is as follows: In patients with severe refractory eosinophilic asthma, who have been established on mepolizumab:
- increased asthma symptoms (exacerbations) will have no evidence of airway eosinophilia and will be clinically mild events associated with small reductions in lung function which may not require rescue oral corticosteroids.
Outline plan of investigation This will be an open observational multi-centre, cohort study in participants with severe asthma (Global Initiative for Asthma (GINA) Steps 4 and 5 classification of asthma severity) who are initiated on Mepolizumab in line with the NICE/SMC (National institute foe Health and Care Excellence) Clinical Guidelines.
The study is exploratory and will assess deteriorations in asthma control to characterise the clinical severity of each exacerbation and the airway and systemic inflammatory phenotype associated with these events. Clinical assessment and management of each exacerbation will be in line with standard clinical guidelines (SIGN 153 (Scottish Intercollegiate Guidelines Network), British Guideline on the Management of Asthma, September 2016).
The study design incorporates a proportion of participants already established on Mepolizumab as well as participants who will be commenced on Mepolizumab on entry to the study. A baseline assessment of medical history, clinical examination, lung function and sputum/blood/urine for analysis will be undertaken along with quality of life questionnaires. Those newly started on Mepolizumab, will be assessed in a similar manner 3 months into the study.
Subjects will be given an electronic peak flow recorder, symptoms diary and action plan for change in baseline symptoms. Participants will be asked to contact the clinic when they feel there has been a decline in asthma control and before they take rescue treatment, a clinic visit will be arranged. At this visit, all participants will have full medical assessment and clinical management based on detailed medical history, clinical findings and lung function measurement. Blood will be taken as part of this clinical assessment as outlined in the schedule of study procedures including biobanking of samples for whole blood gene expression, serum, plasma, sputum and urine. These samples will be stored for validation of additional biomarkers, aligned with the RASP-UK (Refractory Asthma Stratification Programme-UK) biomarker corticosteroid optimisation study.
Number in study:
This is a study will take place across 4 NHS sites within the UK, namely Belfast, Glasgow, Oxford and Leicester.
The study design incorporates a proportion of participants already established on Mepolizumab and also participants starting on Mepolizumab, allowing recruitment of up to 150 participants in a 6 - 9 month window (all sites have large numbers of patients on the waiting list for the drug). Assuming a conservative 0.7 exacerbations per patient per year on mepolizumab (ca 160 events in an 18 month period) and a minimum rate of attendance of 65% this is 102 observed episodes. The study will be terminated when 100 clinical assessments at exacerbation in total have been completed across all sites for participants on Mepolizumab prior to initiation of rescue treatment. The expected duration of study per participant is 24 months.
- Conditions
- Asthma Brittle
- Keywords
- Monoclonal antibody, Mepolizumab, Eosinophil
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of asthma exacerbations requiring administration of corticosteroids
Mepolizumab is considered to be a steroid sparing drug resulting in a reduced number of asthma exacerbations. Patients will be reviewed when asthma symptoms worsen to assess the cause of loss of asthma control and ascertain if the exacerbations requires administration of corticosteroids.
Measured: Throughout study completion, an average of 2 years
Forced Expiratory Volume in 1 second
Spirometry to assess Forced Expiratory Volume in 1 (FEV1) second will be performed at baseline entry to the study and on worsening of asthma symptoms. Spirometry will performed in keeping with the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines.
Measured: Throughout study completion, an average of 2 years
Forced vital capacity
Spirometry to assess Forced Vital Capacity (FVC) will be undertaken at baseline and at worsening of asthma symptoms. Spirometry will performed in keeping with the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines.
Measured: Throughout study completion, an average of 2 years
Fractional expired nitric oxide (feno)
Feno will be measured at baseline and during unscheduled visits to assess airway inflammation.
Measured: Throughout study completion, an average of 2 years
Mini-AQLQ
The mini-Asthma Quality of Life Questionnaire (mini-AQLQ) will be used throughout the study to assess effect of asthma on the subject's quality of life.
Measured: Throughout study completion, an average of 2 years
Asthma control questionnaire (ACQ)
The Asthma control questionnaire (ACQ) will be used throughout the study to assess effect of asthma on the subject's quality of life.
Measured: Throughout study completion, an average of 2 years
Saint George's Respiratory Questionnaire (SGRQ).
The Saint George's Respiratory Questionnaire (SGRQ)will be used throughout the study to assess effect of asthma on the subject's quality of life.
Measured: Throughout study completion, an average of 2 years
Eosinophils
Complete blood count with breakdown of individual cell counts will be measured at baseline and worsening of asthma symptoms
Measured: Throughout study completion, an average of 2 years
C reactive protein
Serum C reactive protein will be measured at baseline and worsening of asthma symptoms.
Measured: Throughout study completion, an average of 2 years
Sputum analysis
The breakdown of the sputum white cell count will be analysed to assess for eosinophilia and neutrophilia.
Measured: Throughout study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Dec 2017
- Primary completion29 Jun 2019
- Study completion29 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Asthma BrittleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- RASP (Refractory Asthma Stratification Programme), Medical Research Council, University of Oxford, University of Leicester, NHS Greater Glasgow and Clyde, Belfast Health and Social Care Trust
- Responsible party
- Principal investigator, Liam Heaney, Queen's University, Belfast
- Investigators
- Liam Heaney, MB Bch BaO, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324230
- Sponsor's protocol ID
- B17/30
- Status last verified
- Jul 2019
- First submitted
- 26 Sep 2017
- Last updated
- 10 Jul 2019
- Results posted
- No
- FDA-regulated device
- No
Publications
Smith DH, Malone DC, Lawson KA, Okamoto LJ, Battista C, Saunders WB. A national estimate of the economic costs of asthma. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):787-93. doi: 10.1164/ajrccm.156.3.9611072.
PubMed 9309994Barnes PJ, Jonsson B, Klim JB. The costs of asthma. Eur Respir J. 1996 Apr;9(4):636-42. doi: 10.1183/09031936.96.09040636.
PubMed 8726924Sweeney J, Brightling CE, Menzies-Gow A, Niven R, Patterson CC, Heaney LG; British Thoracic Society Difficult Asthma Network. Clinical management and outcome of refractory asthma in the UK from the British Thoracic Society Difficult Asthma Registry. Thorax. 2012 Aug;67(8):754-6. doi: 10.1136/thoraxjnl-2012-201869. Epub 2012 May 11.
PubMed 22581823Ahmad F, Roman J. Treating refractory asthma with antibodies against IL-5: is it ready for prime time? Expert Rev Respir Med. 2009 Jun;3(3):227-30. doi: 10.1586/ers.09.22.
PubMed 20477317Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X.
PubMed 22901886Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.
PubMed 22743675McDowell PJ, Diver S, Yang F, Borg C, Busby J, Brown V, Shrimanker R, Cox C, Brightling CE, Chaudhuri R, Pavord ID, Heaney LG; Medical Research Council: Refractory Asthma Stratification Programme (RASP-UK Consortium). The inflammatory profile of exacerbations in patients with severe refractory eosinophilic asthma receiving mepolizumab (the MEX study): a prospective observational study. Lancet Respir Med. 2021 Oct;9(10):1174-1184. doi: 10.1016/S2213-2600(21)00004-7. Epub 2021 May 7.
PubMed 33971168
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exacerbation Profile in Patients on Mepolizumab for Severe Refractory Eosinophilic Asthma- an Exploratory Study.
- ClinicalTrials.gov ID
- NCT03324230
- Acronym / sponsor ID
- B17/30
- Conditions
- Asthma Brittle
- Keywords
- Monoclonal antibody, Mepolizumab, Eosinophil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- RASP (Refractory Asthma Stratification Programme), Medical Research Council, University of Oxford, University of Leicester, NHS Greater Glasgow and Clyde, Belfast Health and Social Care Trust
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 29 Jun 2019 (actual)
- Study completion
- 29 Jun 2019 (actual)
- First posted
- 27 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.
This is a multicentre, observational study focusing on exacerbation events in patients with severe eosinophilic asthma on Mepolizumab.
Mepolizumab is an anti-IL5 (Interleukin 5) monoclonal antibody which blocks the eosinophilic activation pathways associated with decreasing asthma control. The pre-licensing studies have shown that Mepolizumab decreases asthma exacerbation events by approximately 50%, this study seeks to understand the underlying mechanisms of the remaining 50% of exacerbations.
The study will enrol patients within GINA classification 4 and 5 who are known to difficult asthma services across four UK sites. Some patients will recently have been commenced on Mepolizumab, whilst others will be commenced on the drug on entry to the study. The patients will have baseline measurements of biomarkers, lung function, sputum analysis and quality of life questionnaires on study entry, after which patients will be asked to contact the clinic at the first signs of worsening asthma symptoms to arrange a clinic visit prior to commencing rescue treatment. They will be clinically assessed with review of peak flow and symptom diaries, measurements taken at baseline will be repeated and a decision on the nature of the exacerbation and treatment required will be made.
This is an observational study, all outcomes will be exploratory.
Detailed description
Background:
Around 15% of the United Kingdom (UK) have asthma, of these, 10-20% have asthma which is difficult to control using current therapies and with high levels of morbidity resulting. These patients consume 50-60% of the UK healthcare costs of asthma and as such, there is much interest in developing novel treatments for this group.
The heterogeneity of inflammatory pathways underlying asthma are of great interest with development of biomarkers useful for phenotyping asthmatic patients and allowing more accurate assessment of their response to treatment. Traditionally, oral corticosteroids are used in eosinophilic 'T2-high' asthmatic patients with good therapeutic effect, however, there are a group of T2-high patients who have refractory type-2 cytokine driven inflammation and airway eosinophilia despite oral corticosteroids. As such, there are several novel biological agents being engineered to block type 2 cytokine pathways including antagonists to IL5, IL13 and IL4 (Interleukin 5, 13, 4).
Mepolizumab is a humanised monoclonal antibody against IL5. Through a selective inhibition of eosinophilic inflammation, the agent reduces the number of eosinophils in sputum and blood, with important clinical outcomes such as a reduction of asthma exacerbations and a need for systemic glucocorticoids. The pre-licencing clinical trials have shown that selective inhibition of IL5 and presumptive removal of eosinophils reduces exacerbations by 50%, but while this is a significant reduction, patients with severe asthma continue to have severe exacerbations requiring systemic corticosteroid administration.
Therefore, the point of interest is eliciting the inflammatory phenotype and physiological characteristics of the remaining 50% of exacerbations and ascertaining whether systemic corticosteroids have a role when the IL-5 pathway has been blocked by Mepolizumab.
Purpose/ Aim This is an observational study designed to phenotype exacerbations or worsening asthma control when participants are established on Mepolizumab. The study will look for changes in lung function, biomarkers and patient symptoms scores.
The hypothesis is as follows: In patients with severe refractory eosinophilic asthma, who have been established on mepolizumab:
- increased asthma symptoms (exacerbations) will have no evidence of airway eosinophilia and will be clinically mild events associated with small reductions in lung function which may not require rescue oral corticosteroids.
Outline plan of investigation This will be an open observational multi-centre, cohort study in participants with severe asthma (Global Initiative for Asthma (GINA) Steps 4 and 5 classification of asthma severity) who are initiated on Mepolizumab in line with the NICE/SMC (National institute foe Health and Care Excellence) Clinical Guidelines.
The study is exploratory and will assess deteriorations in asthma control to characterise the clinical severity of each exacerbation and the airway and systemic inflammatory phenotype associated with these events. Clinical assessment and management of each exacerbation will be in line with standard clinical guidelines (SIGN 153 (Scottish Intercollegiate Guidelines Network), British Guideline on the Management of Asthma, September 2016).
The study design incorporates a proportion of participants already established on Mepolizumab as well as participants who will be commenced on Mepolizumab on entry to the study. A baseline assessment of medical history, clinical examination, lung function and sputum/blood/urine for analysis will be undertaken along with quality of life questionnaires. Those newly started on Mepolizumab, will be assessed in a similar manner 3 months into the study.
Subjects will be given an electronic peak flow recorder, symptoms diary and action plan for change in baseline symptoms. Participants will be asked to contact the clinic when they feel there has been a decline in asthma control and before they take rescue treatment, a clinic visit will be arranged. At this visit, all participants will have full medical assessment and clinical management based on detailed medical history, clinical findings and lung function measurement. Blood will be taken as part of this clinical assessment as outlined in the schedule of study procedures including biobanking of samples for whole blood gene expression, serum, plasma, sputum and urine. These samples will be stored for validation of additional biomarkers, aligned with the RASP-UK (Refractory Asthma Stratification Programme-UK) biomarker corticosteroid optimisation study.
Number in study:
This is a study will take place across 4 NHS sites within the UK, namely Belfast, Glasgow, Oxford and Leicester.
The study design incorporates a proportion of participants already established on Mepolizumab and also participants starting on Mepolizumab, allowing recruitment of up to 150 participants in a 6 - 9 month window (all sites have large numbers of patients on the waiting list for the drug). Assuming a conservative 0.7 exacerbations per patient per year on mepolizumab (ca 160 events in an 18 month period) and a minimum rate of attendance of 65% this is 102 observed episodes. The study will be terminated when 100 clinical assessments at exacerbation in total have been completed across all sites for participants on Mepolizumab prior to initiation of rescue treatment. The expected duration of study per participant is 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients known to Difficult Asthma services within the NHS, who are eligible for Mepolizumab treatment as per NICE guidelines.
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 80 years at Visit 1
- Able and willing to provide written informed consent and to comply with the study protocol including being able to contact the clinical center and to attend for assessment during a symptomatic deterioration
- Severe asthma despite confirmed after assessment by an asthma specialist
- Diagnosed with asthma at least 12 months prior to screening
Key exclusion criteria (5 listed)
- Acute exacerbation requiring oral corticosteroids in 4 weeks before screening.
- Other clinically significant medical disease or uncontrolled concomitant disease despite treatment that is likely, in the opinion of the investigator, to require a change in therapy or impact the ability to participate in the study
- History of current alcohol, drug, or chemical abuse or past abuse that would impair or risk the subject's full participation in the study, in the opinion of the investigator
- Treatment with an investigational agent within 30 days of visit 1 (or 5 half-lives of the investigational agent, whichever is longer)
- Female subjects who are pregnant or lactating (excluded as candidates for Mepolizumab in clinic prior to study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of asthma exacerbations requiring administration of corticosteroids
Time frame: Throughout study completion, an average of 2 years
Mepolizumab is considered to be a steroid sparing drug resulting in a reduced number of asthma exacerbations. Patients will be reviewed when asthma symptoms worsen to assess the cause of loss of asthma control and ascertain if the exacerbations requires administration of corticosteroids.
Forced Expiratory Volume in 1 second
Time frame: Throughout study completion, an average of 2 years
Spirometry to assess Forced Expiratory Volume in 1 (FEV1) second will be performed at baseline entry to the study and on worsening of asthma symptoms. Spirometry will performed in keeping with the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines.
Forced vital capacity
Time frame: Throughout study completion, an average of 2 years
Spirometry to assess Forced Vital Capacity (FVC) will be undertaken at baseline and at worsening of asthma symptoms. Spirometry will performed in keeping with the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines.
Fractional expired nitric oxide (feno)
Time frame: Throughout study completion, an average of 2 years
Feno will be measured at baseline and during unscheduled visits to assess airway inflammation.
Mini-AQLQ
Time frame: Throughout study completion, an average of 2 years
The mini-Asthma Quality of Life Questionnaire (mini-AQLQ) will be used throughout the study to assess effect of asthma on the subject's quality of life.
Asthma control questionnaire (ACQ)
Time frame: Throughout study completion, an average of 2 years
The Asthma control questionnaire (ACQ) will be used throughout the study to assess effect of asthma on the subject's quality of life.
Saint George's Respiratory Questionnaire (SGRQ).
Time frame: Throughout study completion, an average of 2 years
The Saint George's Respiratory Questionnaire (SGRQ)will be used throughout the study to assess effect of asthma on the subject's quality of life.
Eosinophils
Time frame: Throughout study completion, an average of 2 years
Complete blood count with breakdown of individual cell counts will be measured at baseline and worsening of asthma symptoms
C reactive protein
Time frame: Throughout study completion, an average of 2 years
Serum C reactive protein will be measured at baseline and worsening of asthma symptoms.
Sputum analysis
Time frame: Throughout study completion, an average of 2 years
The breakdown of the sputum white cell count will be analysed to assess for eosinophilia and neutrophilia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Background: PubMed 9309994Smith DH, Malone DC, Lawson KA, Okamoto LJ, Battista C, Saunders WB. A national estimate of the economic costs of asthma. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):787-93. doi: 10.1164/ajrccm.156.3.9611072.
- Background: PubMed 8726924Barnes PJ, Jonsson B, Klim JB. The costs of asthma. Eur Respir J. 1996 Apr;9(4):636-42. doi: 10.1183/09031936.96.09040636.
- Background: PubMed 22581823Sweeney J, Brightling CE, Menzies-Gow A, Niven R, Patterson CC, Heaney LG; British Thoracic Society Difficult Asthma Network. Clinical management and outcome of refractory asthma in the UK from the British Thoracic Society Difficult Asthma Registry. Thorax. 2012 Aug;67(8):754-6. doi: 10.1136/thoraxjnl-2012-201869. Epub 2012 May 11.
- Background: PubMed 20477317Ahmad F, Roman J. Treating refractory asthma with antibodies against IL-5: is it ready for prime time? Expert Rev Respir Med. 2009 Jun;3(3):227-30. doi: 10.1586/ers.09.22.
- Background: PubMed 22901886Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X.
- Background: PubMed 22743675Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.
- Derived from this study: PubMed 33971168McDowell PJ, Diver S, Yang F, Borg C, Busby J, Brown V, Shrimanker R, Cox C, Brightling CE, Chaudhuri R, Pavord ID, Heaney LG; Medical Research Council: Refractory Asthma Stratification Programme (RASP-UK Consortium). The inflammatory profile of exacerbations in patients with severe refractory eosinophilic asthma receiving mepolizumab (the MEX study): a prospective observational study. Lancet Respir Med. 2021 Oct;9(10):1174-1184. doi: 10.1016/S2213-2600(21)00004-7. Epub 2021 May 7.
- 2017 GINA Report, Global Strategy for Asthma Management and PreventionLink provided by the sponsor.
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.
Liam Heaney, MB Bch BaO principal investigator
Queen's University, Belfast
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Brittle, run by Queen's University, Belfast at 4 sites in United Kingdom.
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 4 inclusion and 5 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 asthma exacerbations requiring administration of corticosteroids (time frame: Throughout study completion, an average of 2 years). The study lists 10 primary outcomes in all. 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 NCT03324230, which also lists 7 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 10 Jul 2019.