Last updated: 10/20/2022 11:30:12

Epidemiological study Assessing the Burden of Illness Related to Severe Asthma in Quebec

GSK study ID
204485
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2016-29-04
    Observational study model:
    Cohort
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    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
    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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