Exploring Asthma Exacerbations in Mepolizumab Treated Patients
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|ClinicalTrials.gov Identifier: NCT03324230|
Recruitment Status : Completed
First Posted : October 27, 2017
Last Update Posted : July 10, 2019
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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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||146 participants|
|Official Title:||Exacerbation Profile in Patients on Mepolizumab for Severe Refractory Eosinophilic Asthma- an Exploratory Study.|
|Actual Study Start Date :||December 1, 2017|
|Actual Primary Completion Date :||June 29, 2019|
|Actual Study Completion Date :||June 29, 2019|
- 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.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324230
|Queen's University Belfast|
|Belfast, County Antrim, United Kingdom, BT7 1NN|
|Leicester Biomedical Research Centre|
|Leicester, Leicestershire, United Kingdom, LE3 9QP|
|Gartnavel General Hospital, Greater Glasgow and Clyde NHS Trust|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Oxford, United Kingdom|
|Principal Investigator:||Liam Heaney, MB Bch BaO||Queen's University, Belfast|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Liam Heaney, Professor, Queen's University, Belfast|
|Other Study ID Numbers:||
|First Posted:||October 27, 2017 Key Record Dates|
|Last Update Posted:||July 10, 2019|
|Last Verified:||July 2019|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases