Last updated: 02/03/2020 18:30:10

Administrative Database Study on the Impact of Adherence to Drug Therapy in COPD Patients Treated with Tiotropium as Monotherapy or Co-Administered with ADVAIR in Quebec

GSK study ID
116968
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: Administrative Database Study on the Impact of Adherence to Drug Therapy in COPD Patients Treated with Tiotropium as Monotherapy or Co-Administered with ADVAIR in Quebec
Trial description: This will be an observational study that will utilize pharmaceutical and medical claims from the Quebec Provincial Health Insurance administrative databases. Patients diagnosed with chronic obstructive pulmonary diseases (COPD) between January 01, 2001 and March 31, 2011 and have been treated with an anticholinergic (tiotropium or ipratropium bromide) alone or in combination with salbutamol will be selected in the COPD cohort. Patients will be followed from their entry in the cohort through March 31, 2011, death or withdrawal from the insurance plan whichever occurs first. The study assesses the association between adherence and COPD related health care utilization in COPD patients treated with tiotropium alone or co-administered with fluticasone propionate/salmeterol combination in a single inhaler (FSC).Adherence to treatment will be determined on the basis of the Medication Possession Ratio and Persistence. Exacerbations will be defined as use of oral corticosteroids and antibiotics, emergency room visits and hospitalizations related to COPD. Health care utilization will include medication use, visits to physicians and clinics and hospitalizations.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

COPD-related healthcare resource utilization

Timeframe: January 01, 2001 and March 31, 2011

COPD-related exacerbations

Timeframe: January 01, 2001 to March 31, 2011

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Tiotropium plus fluticasone/salmeterol
  • Drug: Tiotropium
    • Enrollment:
    0
    Primary completion date:
    2012-11-12
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Afisi Ismaila; Diane Corriveau; Julie Vaillancourt; Daria Parsons; Anand Dalal; Zhen Su; John Sampalis. Impact of adherence to treatment with tiotropium and fluticasone propionate/salmeterol in chronic obstructive pulmonary diseases patients. Curr Med Res Opin. 2014;30(7):1427-36.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol/norflurane, norflurane, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    November 2012 to December 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    none
    • i. One or more medical claims with a diagnosis of Chronic Bronchitis (ICD-9: 490.xx, 491.xx) COPD (ICD-9: 496.xx) or Emphysema (ICD-9: 492.xx) between January 01, 2001 and March 31, 2011;
    • ii. To be at least 40 years old at the time of treatment initiation, defined as the first COPD prescription filled during the cohort inception period of the study;
    • i. One or more medical claims with a diagnosis of asthma (ICD-9: 493.xx) between January 01, 2001 and March 31, 2011;
    • ii. One or more medical claims with a diagnosis of respiratory tract cancer (ICD-9: 160.xx – 164.xx or 231.xx), cystic fibrosis, fibrosis due to tuberculosis [TB], and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, sarcoidosis between January 01, 2001 and March 31, 2011;
    Inclusion and exclusion criteria
    Inclusion criteria:
    • i. One or more medical claims with a diagnosis of Chronic Bronchitis (ICD-9: 490.xx, 491.xx) COPD (ICD-9: 496.xx) or Emphysema (ICD-9: 492.xx) between January 01, 2001 and March 31, 2011; ii. To be at least 40 years old at the time of treatment initiation, defined as the first COPD prescription filled during the cohort inception period of the study; iii. Two or more pharmacy claims for tiotropium as monotherapy or coadministered with FSC used for the management of COPD as the primary indication.
    Exclusion criteria:
    • i. One or more medical claims with a diagnosis of asthma (ICD-9: 493.xx) between January 01, 2001 and March 31, 2011; ii. One or more medical claims with a diagnosis of respiratory tract cancer (ICD-9: 160.xx – 164.xx or 231.xx), cystic fibrosis, fibrosis due to tuberculosis [TB], and bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary TB, sarcoidosis between January 01, 2001 and March 31, 2011; iii. Any prescriptions for methylxanthine or theophylline between January 01, 2001 and March 31, 2011 including but not limited to the formulations listed in

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    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
    2012-11-12
    Actual study completion date
    2012-11-12

    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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