Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial (COPD-HELP)
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|ClinicalTrials.gov Identifier: NCT04075331|
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : November 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|COPD Eosinophilia||Drug: Mepolizumab Drug: Placebo||Phase 2 Phase 3|
Patients admitted to hospital with an exacerbation of COPD are at high risk of readmission, of which a proportion are driven by eosinophilic inflammation. Whilst oral corticosteroids are beneficial in exacerbations, a considerable proportion of patients experience treatment failure, with 50% of patients readmitted within 3 months (www.RCPLondon.ac.uk).
Therapy, such as mepolizumab, reduces eosinophil count and has been shown to reduce exacerbation frequency when given in the stable state in both eosinophilic asthma (Papi et al. 2018) and COPD (Yousef, in press).
The investigators hypothesise that starting mepolizumab at the time of a hospitalisation for an exacerbation of COPD in patients with significant eosinophilia will result in a reduction in readmission to hospital in a high risk population.
Therefore, 238 participants will be recruited over an 18-month period and will be randomised into a 48-week treatment period in which they will receive monthly subcutaneous injections of either 100 mg mepolizumab or placebo. Secondary outcomes will be measured at baseline (week 0), 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomised Controlled Trial of Mepolizumab Initiated Following Admission to Hospital for a Severe Exacerbation of Eosinophilic COPD|
|Actual Study Start Date :||September 7, 2020|
|Estimated Primary Completion Date :||January 30, 2023|
|Estimated Study Completion Date :||January 30, 2023|
Mepolizumab 100mg subcutaneous injection
Placebo Comparator: Placebo
Saline solution for subcutaneous injection
Other Name: Saline solution
- Time from randomisation to next hospital readmission or death (all cause) [ Time Frame: 48 weeks ]To evaluate the efficacy of mepolizumab initiated following hospitalisation on future hospital readmission or death (all cause) compared with placebo and standard medical therapy in severe exacerbations of eosinophilic COPD.
- Time from randomisation to first hospital readmission or death due to a respiratory cause [ Time Frame: 48 weeks ]
- Total number of hospital readmissions all cause over 48 weeks [ Time Frame: 48 weeks ](adjusted for time minimum 24 weeks of trial treatment)
- Total number of moderate exacerbations over 48 weeks [ Time Frame: 48 weeks ](adjusted for time minimum 24 weeks of trial treatment)
- Time from randomisation to treatment failure [ Time Frame: 48 weeks ](defined as readmission, need for further treatment or death)
- Time from randomisation to death (all cause) [ Time Frame: 48 weeks ]
- Time from randomisation to death (respiratory cause) [ Time Frame: 48 weeks ]
- Time from randomisation to first hospital readmission (all cause) [ Time Frame: 48 weeks ]
- Time from randomisation to first hospital readmission (respiratory cause) [ Time Frame: 48 weeks ]
- Length of index hospital admission [ Time Frame: 48 weeks ]Time from admission to discharge of first hospital admission
- Extended Medical Research Council dyspnoea score (eMRC) [ Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 ]This scale measures perceived respiratory disability. Participants rate their grades of breathlessness on a scale of 1 (least) to 5 (worst). The extension divides the grade 5 rating into 'a' (independent) and 'b' (dependent) to establish dependence on others for washing and dressing.
- St George's Respiratory Questionnaire (SGRQ) [ Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 ]This 50-item questionnaire measures health status (quality of life) in patients with diseases of airway obstruction. Scores are broken down into 'symptoms' (normal participant range 9-15), 'activity' (normal participant range 7-12), 'impacts' (normal participant range 1-3), and a total score (normal participant range 5-7). Higher scores indicate poorer health status.
- COPD Assessment Tool (CAT) [ Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 ]The COPD Assessment Test (CAT) is a questionnaire for people with Chronic Obstructive Pulmonary Disease (COPD). It is designed to measure the impact of COPD on a person's life, and how this changes over time. Scores range from 0-40, with higher scores indicating greater impact of COPD on a patient's life.
- Warwick-Edinburgh Mental wellbeing scale (WEMWBS) [ Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 ]This scale measures mental wellbeing using a 14-item scale. The scoring range for each item is from 1 - 5 and the total score is from 14-70, with higher scores indicating better mental wellbeing.
- London Chest Activities of Daily Living Questionnaire (LCADL) [ Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 ]This 15-item questionnaire measures dyspnoea during routine daily activities in patients with COPD. It consists of four components: 'Self-care', 'Domestic', 'Physical' and 'Leisure'. Patients score from 0: 'I wouldn't do anyway', to 5: 'Someone else does this for me (or helps)', with higher scores representing maximal disability.
- Post-bronchodilator lung function - Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 ]
- Post-bronchodilator lung function - Forced Vital Capacity (FVC) [ Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 ]
- Lung function - Oscillometry [ Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 ]
- Short physical performance battery (SPPB) [ Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 ]This assessment measures lower extremity functioning in older individuals. Lower scores indicate greater impairment.
- Physical activity using accelerometry [ Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 ]
- Handgrip Strength [ Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 ]
- Total Serum eosinophil count (inflammatory markers) [ Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 ]
- Percentage sputum eosinophil count (inflammatory markers) [ Time Frame: Weeks 0, 4, 8, 12, 24, 36, 48 ]
- Adverse Events (AEs) [ Time Frame: 48 weeks ]
- Serious Adverse Events (SAEs) [ Time Frame: 48 weeks ]
- Heart Rate (beats per minute) [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 ]
- Blood pressure (systolic/diastolic mmHg) [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 ]
- Temperature (degrees) [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 ]
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): NCT04075331
|Contact: Nafisa Boota - Senior Trial Manager||+44 (0)116 229 email@example.com|
|NIHR Biomedical Research Centre, Respiratory||Recruiting|
|Leicester, Leicestershire, United Kingdom, LE1 9QP|
|Contact: Neil Greening +44 (0)116 258 3474 firstname.lastname@example.org|
|Principal Investigator: Christopher Brightling|
|Principal Investigator: Neil Greening|
|Sub-Investigator: Wadah Ibrahim|
|Study Chair:||Christopher Brightling||University of Leicester|
|Principal Investigator:||Neil Greening||University of Leicester|