Status:
COMPLETED
Exploring Asthma Exacerbations in Mepolizumab Treated Patients
Lead Sponsor:
Queen's University, Belfast
Collaborating Sponsors:
RASP (Refractory Asthma Stratification Programme)
Medical Research Council
Conditions:
Asthma Brittle
Eligibility:
All Genders
18-80 years
Brief 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 w...
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 pa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
December 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 29 2019
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT03324230
Start Date
December 1 2017
End Date
June 29 2019
Last Update
July 10 2019
Active Locations (4)
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1
Queen's University Belfast
Belfast, County Antrim, United Kingdom, BT7 1NN
2
Leicester Biomedical Research Centre
Leicester, Leicestershire, United Kingdom, LE3 9QP
3
Gartnavel General Hospital, Greater Glasgow and Clyde NHS Trust
Glasgow, Scotland, United Kingdom, G12 0YN
4
Oxford University
Oxford, United Kingdom