Last updated: 10/20/2022 11:30:12
Epidemiological study Assessing the Burden of Illness Related to Severe Asthma in Quebec
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Epidemiological study Assessing the Burden of Illness Related to Severe Asthma in Quebec
Trial description: The current study is planned to obtain the information related to healthcare resource utilization and related direct healthcare cost of severe asthmatics in Canada in a Quebec real-life clinical setting through the characterization of resource use and costs associated with severe asthmatic subjects. This will be an observational retrospective cohort study that will utilize pharmaceutical and medical claims from the Quebec Provincial Health Insurance administrative databases. This study will utilize a cohort of severe asthmatic subjects identified from a database of asthma patients extracted from the Régie de l’Assurance Maladie du Québec (RAMQ) data. The subjects will be followed from the time of their first diagnosis with severe asthma to their last known follow-up between January 01, 2001 and March 31, 2011 or death.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Health care utilization (HCU)
Timeframe: The time point at which the participant entered into the cohort, to March 31, 2011, death, or withdrawal from the insurance plan whichever occurs first (assessed up to maximum duration of 10 years).
Direct healthcare cost
Timeframe: Direct health care costs related to asthma treatment will be will be ascertained for each patient from the index date, death, or withdrawal from the insurance plan, whichever occurs first (assessed up to maximum duration of 10 years).
Secondary outcomes:
Not applicable
Interventions:
Other: Not applicable
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2016-29-04
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
None
Study date(s)
June 2015 to April 2016
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
none
- Inclusion Criteria:
- To be at least 12 years old at the time of treatment initiation, defined as the first asthma prescription filled during the cohort inception period of the study (from January 01, 2001 to December 31, 2010).
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- To be at least 12 years old at the time of treatment initiation, defined as the first asthma prescription filled during the cohort inception period of the study (from January 01, 2001 to December 31, 2010).
- To have coverage in RAMQ and available data for a minimum of two years prior to the diagnosis of asthma in order to ensure accurate assessments of medical history during the study look-back period.
- One or more pharmacy claim(s) for the following asthma medication(s), as described in table below, within <= four weeks following medical claim including asthma: beclomethasone diproprionate, budesonide, ciclesonide, fenoterol, fluticasone propionate, formoterol (fumarate & fumarate dihydrate), formoterol/budesonide, mometasone furoate, montelukast, omalizumab, salmeterol, salmeterol/fluticasone, salbutamol-hydrofluoroalkane, theophylline, terbutaline, zafirlukast.
- To have severe asthma, a subject must qualify under Global Initiative for Asthma
Trial location(s)
No location data available.
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
Finalized
Actual primary completion date
2016-29-04
Actual study completion date
2016-29-04
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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