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Exploring Asthma Exacerbations in Mepolizumab Treated Patients

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ClinicalTrials.gov Identifier: NCT03324230
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : April 13, 2018
Sponsor:
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
Information provided by (Responsible Party):
Liam Heaney, Queen's University, Belfast

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 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
Asthma Brittle

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exacerbation Profile in Patients on Mepolizumab for Severe Refractory Eosinophilic Asthma- an Exploratory Study.
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Mepolizumab




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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
Whole blood, sputum, urine.


Information from the National Library of Medicine

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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
Study Population
Patients known to Difficult Asthma services within the NHS, who are eligible for Mepolizumab treatment as per NICE guidelines.
Criteria

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 80 years at Visit 1
  2. 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
  3. Severe asthma despite confirmed after assessment by an asthma specialist
  4. Diagnosed with asthma at least 12 months prior to screening

Exclusion Criteria:

  1. Acute exacerbation requiring oral corticosteroids in 4 weeks before screening.
  2. 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
  3. 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
  4. Treatment with an investigational agent within 30 days of visit 1 (or 5 half-lives of the investigational agent, whichever is longer)
  5. Female subjects who are pregnant or lactating (excluded as candidates for Mepolizumab in clinic prior to study)

Information from the National Library of Medicine

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


Contacts
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Contact: Pamela Jane McDowell, MBBS +7788320333 janemcdowell@doctors.org.uk
Contact: Liam Heaney, MB Bch BaO +442890976376 l.heaney@qub.ac.uk

Locations
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United Kingdom
Queen's University Belfast Recruiting
Belfast, County Antrim, United Kingdom, BT7 1NN
Contact: Pamela Jane McDowell, MBBS    +7788320333    janemcdowell@doctors.org.uk   
Contact: Liam Heaney, MB Bch BaO    +44290976376    l.heaney@qub.ac.uk   
Leicester Biomedical Research Centre Recruiting
Leicester, Leicestershire, United Kingdom, LE3 9QP
Contact: Sarah Diver       sed22@leicester.ac.uk   
Contact: Christopher Brightling       ceb17@leicester.ac.uk   
Gartnavel General Hospital, Greater Glasgow and Clyde NHS Trust Recruiting
Glasgow, Scotland, United Kingdom, G12 0YN
Contact: Jieqiong Yang       jieqiong.yang@nhs.net   
Contact: Rekha Chaudhur       Rekha.Chaudhuri@ggc.scot.nhs.uk   
Oxford University Not yet recruiting
Oxford, United Kingdom
Contact: Ian Pavord       ian.pavord@ndm.ox.ac.uk   
Sponsors and Collaborators
Queen's University, Belfast
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
Investigators
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Principal Investigator: Liam Heaney, MB Bch BaO Queen's University, Belfast

Publications:
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Responsible Party: Liam Heaney, Professor, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT03324230     History of Changes
Other Study ID Numbers: B17/30
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Liam Heaney, Queen's University, Belfast:
Monoclonal antibody
Mepolizumab
Eosinophil

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases