Inflammation Following Mepolizumab and Oral Corticosteroids in Asthma (MAPLE)
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|ClinicalTrials.gov Identifier: NCT03610685|
Recruitment Status : Completed
First Posted : August 1, 2018
Last Update Posted : March 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Prednisolone Drug: Placebo oral capsule||Phase 4|
Mepolizumab, a humanized monoclonal antibody (mAb) antagonizes IL-5 and through a selective inhibition of eosinophilic inflammation, reduces the number of eosinophils in sputum and blood, leading to a reduction in asthma exacerbations and a need for systemic glucocorticoids. Once this therapy has been initiated for severe eosinophilic asthma, the additional role of oral corticosteroids is questionable as their main target is reduction of eosinophils and hence responsiveness to oral corticosteroids in patients in a stable state of asthma may reduce.
Using two weeks of high dose prednisolone versus placebo in a crossover design after 12 weeks of mepolizumab therapy will allow an understanding of the pathways that remain steroid responsive following IL-5 suppression.
This is an exploratory study with no single primary end point. The objective of the study is to assess the change in airway inflammation following oral corticosteroids versus placebo and the airway inflammation while on mepolizumab in stable state of asthma.
Note: Mepolizumab is not an intervention in this study; it is initiated as part of usual NHS care.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Persistence of Inflammation and Study of T2 Pathways Following Inhibition of InterLeukin-5 With Mepolizumab in Severe Eosinophilic Asthma|
|Actual Study Start Date :||October 19, 2018|
|Actual Primary Completion Date :||January 7, 2020|
|Actual Study Completion Date :||January 7, 2020|
Placebo Comparator: Placebo
Participants will be given 2 weeks of placebo treatment. The placebo capsules will be taken once a day orally. The daily dose of placebo treatment will match the Prednisone dose for each participant.
Drug: Placebo oral capsule
Given daily for 2 weeks
Other Name: Placebo
Active Comparator: Prednisolone
Participants will be given 2 weeks of prednisolone treatment. This is administered orally once a day. The daily dose is calculated according to 0.5mg/kg with a maximum dose of 40mg per day.
Given daily for 2 weeks
- Change in exhaled nitric oxide measured in parts per billion [ Time Frame: Through study completion, an average 20 weeks. ]Measured at study visits using a Niox machine.
- Change in sputum differential cell counts measured in absolute cell count. [ Time Frame: Through study completion, an average 20 weeks ]Induced sputum
- Change in asthma control and quality of life questionnaires [ Time Frame: Through study completion, an average 20 weeks. ]
Asthma control questionnaire includes 5 questions related to asthma control. Each question is scored from 0 to 6 with the highest number representing poorer outcome / asthma control.
Asthma quality of life questionnaire includes 32 questions related to quality of life. Each question is scored from 1 to 7 with the highest number representing better outcome / quality of life.
- Change in visual asthma symptom scores [ Time Frame: Through study completion, an average 20 weeks ]Symptoms visual analogue scale asks 3 questions related to asthma control. A
- Oscillometry [ Time Frame: Through study completion, an average 20 weeks ]For small airway function to correlate with inflammation
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): NCT03610685
|Asthma and copd research centre|
|Glasgow, United Kingdom, G12 0YN|
|Principal Investigator:||Rekha Chaudhuri, MD||NHS Greater Glasgow and Clyde|