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
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2012-11-12
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)
No location data available.
Study documents
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
Finalized
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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