Real-World Effectiveness of Mepolizumab In Treating Chronic Obstructive Pulmonary Disease: A Multi-Country Prospective Study
Investigating the Effects of an Investigational Medication in Treating Chronic Obstructive Pulmonary Disease
Rajeev Mehta
Primary Investigator
Brief description of study
Evaluate the change in annualized rate of moderate/severe exacerbations in the 12-month period post-mepolizumab initiation compared to the 12-month pre-exposure period
Detailed description of study
This study is a global, real-world, prospective, non-interventional study in patients who have been newly prescribed mepolizumab for treating COPD per physicians’ discretion. This study will not interfere with the standard medical care or impact the patient’s treatment. No visits should be scheduled specifically for this non-interventional study; data will be collected at usual COPD healthcare visits as per SoC. The index date (i.e., Day 1) is defined as the mepolizumab initiation date. Data collection timepoints are at 3 months (PRO data only), 6 months (± 1 month), and at 12, 24, and 36 months (± 3 months) after mepolizumab initiation. Historical COPD disease characteristics and treatment history will be collected at enrollment from the patient’s medical records for the 12 months prior to enrollment (date of COPD diagnosis or start date of treatment can be more than 12 months prior to enrollment).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Chronic Obstructive Pulmonary Disease, COPD
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Age: 40 years - 100 years
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Gender: All
Inclusion criteria
To participate in this study patients must meet all of the following inclusion criteria at
enrollment:
1. Patient is ≥40 years of age at enrollment
2. Patient has had a documented diagnosis of COPD for at least 12 months, as per
physician’s judgment
3. Medical records availability for at least 12 months prior to inclusion in the study
4. Patient has newly initiated treatment with add-on mepolizumab for COPD with an
eosinophilic phenotype or characterized by raised blood eosinophils (as per the
country-specific label for COPD). Physician’s decision to treat the patient with add-
on mepolizumab was made independently of the patient’s participation in the study
(as per standard of care)
5. Patient has been on maintenance inhaled therapy for a minimum of 3 months prior to
enrollment
6. Patient is willing and able to complete study-related questionnaires
7. Patient provides voluntary signed informed consent to participate in the study before
inclusion in the study
Exclusion criteria
Patients who meet any of the following criteria at enrollment are not eligible to
participate in this study:
1. Patient has received mepolizumab for treating COPD more than 7 days prior to the
enrollment.
2. Patient has received mepolizumab for indications other than COPD anytime within 12
months prior to the enrollment.
3. Patient has a documented history of failure with an anti-IL-5/5r therapy, per physician
judgment, for any indication
4. Patient has any condition that—in the opinion of the investigator—may interfere with
the patient’s ability to participate in the study (such as short life expectancy,
substance abuse, severe cognitive impairment, or other comorbidities that can
predictably prevent the patient from completing visits and assessments as per SoC)
5. Patient currently participates in any interventional clinical trial
This study investigates how an investigational medication works for people with Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung disease that makes it hard to breathe and gets worse over time. This study looks at how often people with COPD have flare-ups, or worsening symptoms, after starting the investigational medication compared to before they started it.
Participants in this study will not have any changes to their regular medical care. The study will collect information during normal doctor visits for COPD. Data will be gathered at several points: 3 months, 6 months, and then every year for three years after the medication is started. This is a non-interventional study, meaning it does not change how doctors treat patients.
- Who can participate: Adults aged 40 and older with COPD can participate if they have a history of the disease for at least 12 months. Participants must have started the investigational medication recently and be on maintenance inhaled therapy for at least 3 months prior.
- Study details: Participants will continue their usual treatment for COPD while data is collected during regular healthcare visits. The study will not require any additional visits or changes in their current treatment plan.
