Last updated: 02/04/2020 14:40:06
Health care resource use and costs associated with use of mepolizumab versus placebo in a clinical trial setting
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Health care resource use and costs associated with use of mepolizumab versus placebo in a clinical trial setting
Trial description: Estimating the economic impact of clinically significant exacerbations in patients with severe asthma can help payers make more informed decisions about the management of the severe eosinophilic asthma. The MEA115588 study (a Phase 3 clinical trial of mepolizumab + standard of care (SOC) versus placebo + SOC) provides an opportunity to assess, quantify, and evaluate health care resource use (HCRU) associated with a new therapy. The clinical trial data, combined with cost data from major United States (US) payers, will allow a comparison of cost estimates associated with exacerbations in patients with recurrent severe asthma with signs of eosinophilic inflammation based on randomized treatments. The primary objective of this study is to estimate the incremental asthma exacerbation-related medical costs (defined as costs associated with exacerbations requiring treatment with oral corticosteroids (OCS) or treatment in an emergency department (ED) or a hospitalization) for patients receiving mepolizumab+SOC compared to those receiving placebo+SOC based results from the MEA115588 study. The secondary objective is to estimate the asthma exacerbation-related ED visit/Hospitalization costs for patients receiving mepolizumab+SOC compared to those receiving placebo+SOC based on the MEA115588 study.The current study will be a post-hoc analysis of the MEA115588 trial data where patients with history of recurrent severe asthma exacerbations were randomized to receive mepolizumab versus placebo. However, this protocol finalization will be prior to SAC (statistical analyses complete) milestone for the MEA115588 study hence will represent an a priori analysis. The study is limited to an analysis of direct medical health care costs applied to the rates of HCRU associated with asthma-related exacerbations reported in the MEA115588 clinical trial. A unit-cost method (using standardized costs) will be used to calculate direct medical costs. Each HCRU will be assigned cost weights based on the unit costs estimates.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Asthma exacerbation-related medical costs
Timeframe: 8 months and 12 months
Secondary outcomes:
Hospitalization and emergency department (ED) costs for asthma exacerbations
Timeframe: 8 months and 12 months
Interventions:
Enrollment:
0
Primary completion date:
2014-03-12
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Basu A, Dalal A, Canonica GW, Forshag M, Yancey SW, Nagar S, Bell C. Economic Analysis of the Phase III MENSA Study Evaluating Mepolizumab for Severe Asthma with Eosinophilic Phenotype. Expert Rev Pharmacoecon Outcomes Res. 2017;17(2):121-131.
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
February 2014 to December 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
none
- Able to give written informed consent prior to participation in the study
- At least 12 years of age at visit 1 and a minimum weight of 45 kilogram (kg)
- Current smokers or former smokers with a smoking history of >=10 pack years
- Presence of a known pre-existing, clinically important lung condition other than asthma
Inclusion and exclusion criteria
Inclusion criteria:
- Able to give written informed consent prior to participation in the study
- At least 12 years of age at visit 1 and a minimum weight of 45 kilogram (kg)
- A well-documented requirement for regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS)
- Current treatment with an additional controller medication, besides ICS, for at least 3 months or a documented failure in the past 12 months of an additional controller medication for at least 3 successive months
- Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma
- At Visit 1, a pre-bronchodilator FEV1 <80% (for subjects >= 18 years of age), a pre-bronchodilator FEV1 <90% or FEV1:FVC ratio <0.8 (for subjects 12-17 years of age).
- Previously confirmed history of two or more exacerbations requiring treatment with systemic CS
- Male or Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control)
- French subjects will be included only if either affiliated to or a beneficiary of a social security category.
Exclusion criteria:
- Current smokers or former smokers with a smoking history of >=10 pack years
- Presence of a known pre-existing, clinically important lung condition other than asthma
- A current malignancy or previous history of malignancy in less than 12 months
- Known, pre-existing, unstable liver disease cirrhosis and known biliary abnormalities
- Known, pre-existing severe or clinically significant cardiovascular disease
- Known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment
- Subjects with any eosinophilic diseases
- QTc(F) ≥450msec or QTc(F) ≥480 msec
- A history of alcohol/substance abuse
- Subject with known immunodeficiency
- Subjects who have received omalizumab within 130 days of Visit 1 or any monoclonal antibody (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1
- Subjects who have received treatment with an investigational drug within the past 30 days or five terminal phase half-lives of the drug whichever is longer
- Subjects with allergy/intolerance to a monoclonal antibody or biologic.
- Subjects who are pregnant or breastfeeding
- Subjects who have known evidence of lack of adherence to controller medications and/or ability to follow physician’s recommendations
- Previously participated in any study with mepolizumab and received investigational product (including placebo)
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2014-03-12
Actual study completion date
2014-03-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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