Last updated: 05/01/2019 14:10:30
Burden of illness among patients with eosinophilic severe COPD
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Burden of illness among patients with eosinophilic severe COPD
Trial description: Two clinical trials are currently in progress to examine the effect of mepolizumab in reducing the number of acute exacerbations of chronic obstructive pulmonary disease (AECOPD), reducing health care utilization, and in improving COPD symptoms and health status. There is a need for real-world data on how many subjects may be eligible for treatment with mepolizumab and also to understand the burden of illness and healthcare resource utilization for these subjects. The current retrospective, non-interventional, observational cohort study is required to describe and compare subjects potentially eligible for treatment with mepolizumab with subjects who are not considered eligible for mepolizumab treatment and also to understand the burden of illness and healthcare resource utilization for these subjects. Approximately 1200 treatment-eligible COPD subjects and 42000 treatment-non-eligible subjects will be included in this study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Rate of acute exacerbations of COPD, as a measure of clinical burden of illness
Timeframe: Up to 6 years
Incidence of all-cause mortality, as a measure of clinical burden of illness
Timeframe: Up to 6 years
Annual rate of primary-care consultations as a measure of healthcare resource utilization
Timeframe: 12 months
Annual rate of non-COPD-related hospitalizations, as a measure of healthcare resource utilization
Timeframe: 12 months
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
43500
Primary completion date:
2017-16-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Müllerová H, Meeraus W, Galkin D, Albers F, Landis S. Clinical burden of illness among patients with severe eosinophilic COPD. Int J Chron Obstruct Pulmon Dis. 2019;(14):741-755
DOI: 10.2147/COPD.S194511
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
March 2017 to June 2017
Type
Observational
Phase
3
Participation criteria
Sex
Female & Male
Age
35+ years
Accepts healthy volunteers
Not applicable
- Diagnosis of COPD between 01-Jan-2004 and 31-Dec-2014 at age 35 or more years and confirmed with forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) <0.7 at any time in history.
- A qualifying (non-missing) eosinophil test recorded, on or after their COPD diagnosis and between 01-Jan-2010 and 31-Dec-2014.
- Less than 365 days up-to-standard (UTS) data available in Clinical Practice Research Database (CPRD)-GP Online Database prior to their earliest qualifying eosinophil test record.
- A diagnosis consistent with a COPD exclusion disease, defined as conditions that severely modify COPD natural disease history and/or where COPD is a secondary disease (interstitial fibrotic diseases, cystic fibrosis, lung transplantation or anatomic abnormalities of lungs) recorded prior to their first qualifying eosinophil test record.
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of COPD between 01-Jan-2004 and 31-Dec-2014 at age 35 or more years and confirmed with forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) <0.7 at any time in history.
- A qualifying (non-missing) eosinophil test recorded, on or after their COPD diagnosis and between 01-Jan-2010 and 31-Dec-2014.
Exclusion criteria:
- Less than 365 days up-to-standard (UTS) data available in Clinical Practice Research Database (CPRD)-GP Online Database prior to their earliest qualifying eosinophil test record.
- A diagnosis consistent with a COPD exclusion disease, defined as conditions that severely modify COPD natural disease history and/or where COPD is a secondary disease (interstitial fibrotic diseases, cystic fibrosis, lung transplantation or anatomic abnormalities of lungs) recorded prior to their first qualifying eosinophil test record.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
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
2017-16-06
Actual study completion date
2017-16-06
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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