Last updated: 12/20/2019 09:00:10

Impact of early versus late co-administration of Advair in patients treated with tiotropium for the management of COPD in Quebec

GSK study ID
201673
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: Impact of early versus late co-administration of Advair in patients treated with tiotropium for the management of COPD in Quebec
Trial description: Long Acting bronchodilators such as long acting anticholinergics and long acting β2-agonists are recommended first line treatments for the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients with persistent symptoms. One of the goals of treatment in COPD is to prevent exacerbations that are known to deteriorate pulmonary function and quality of life and increase the risk of death.
For patients not responding to first line treatment, the use of combination therapy with an inhaled corticosteroid (ICS) and a long acting β2-agonist (LABA) is recommended. Optimal pharmacotherapies for COPD patients who remain symptomatic on a long acting bronchodilator and have a history of exacerbation include the addition of combination therapy to a long acting anticholinergic. ADVAIR is a combination of fluticasone propionate, an ICS and salmeterol a LABA that is approved for the maintenance treatment of COPD in patients.
To date, there are no population-based Canadian data on the rate and timing of the addition of ADVAIR to tiotropium, a long-acting anticholinergic, in the management of COPD patients. In addition, the effect of the delays in initiating combination therapy of tiotropium and ADVAIR on the risk of exacerbations and disease burden has not been addressed in a real-life setting within the Canadian health care system.
The current study will address these knowledge gaps by utilizing the administrative database of the Quebec Provincial Health Insurance (RAMQ) to conduct a retrospective cohort study of patients with COPD that are treated with tiotropium.
The ultimate aim of this study will be to assess the impact of early versus late co-administration of ADVAIR in patients treated with tiotropium for the management of COPD in Quebec. In addition, the study will assess the incremental benefits of ADVAIR co-administration with tiotropium in the management of patients with COPD in Quebec. The study will also provide insight on the medical decision making and the profile of COPD patients for whom ADVAIR is added to tiotropium.
ADVAIR is a trademark of the GlaxoSmithKline Group of Companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

COPD Exacerbations

Timeframe: n/a

Secondary outcomes:

Healthcare Resource Utilization

Timeframe: n/a

Interventions:
  • Other: n/a
    • Enrollment:
    1
    Primary completion date:
    2017-06-06
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Advair Product Monograph, GSK Canada, April 2, 2012
    Dala, Anand A., Laura Christensen, Fang Liu and Aylin A Riedel. “Direct costs of Chronic obstructive disease among managed care patients.” International Journal of Chronic Obstructive Pulmonary Disease. 2010:5, 341-349.
    Restrepo, Ruben D. “A Stepwise Approach to Management of Stable COPD With Inhaled Pharmacotherapy: A Review.” Respiratory Care. 2009; Vol. 54 No. 8, 1058-1080.
    Tamblyn R, Lavoie G, Petrella L, Monette J. The use of prescription claims databases in pharmacoepidemiological research: the accuracy and comprehensiveness of the prescription claims database in Québec. J Clin Epidemiol. 1995;48:999-1009.
    Schmier, Jordana K., Michael T. Halpern and Mechelle L. Jones. “Effects of Inhaled Corticosteroids on Mortality and Hospitalization in Elderly Asthma and Chronic Obstructive Pulmonary Disease Patients - Appraising the evidence.” Drugs Aging. 2005; 22 (9): 717-729.
    Neyt, Mattias, Stephane Devriese, Nancy Thiry and Ann Van den Bruel. “Tiotropium’s cost-effectiveness for the treatment of COPD: a cost-utility analysis under real-world conditions.” BMC Pulmonary Medicine. 2010, 10:47, 1-10.
    Maper DW, Hurley JS, Dalal AA, Blanchette CM. The role of combination inhaled corticosteroid/long-acting beta-agonist therapy in COPD management. Prim Care Respir J 2010;19:93-103.
    COPD Facts and Figures. From Life and Breath: Respiratory Disease in Canada. Report of the Public Health Agency of Canada, 2007.
    Douglas, Mapel W., Judith S Hurley, Anand A Dalal and Christopher M Blanchette. “The role of combination inhaled corticosteroid/long-acting Bagonist therapy in COPD management.” Primary Care Respiratory Journal. 2010; 19(2): 93-103.
    Health Indicators 2008. Canadian Institute of Health Information. Page 21. HYPERLINK "http://secure.cihi.ca/cihiweb/products/ Healthindicators2008_Engweb.pdf"http://secure.cihi.ca/cihiweb/product s/ Healthindicators2008_Engweb.pdf
    Centre for Chronic Disease Prevention and Control, Public Health Agency of Canada, using data from Canadian Community Health Survey, Statistics Canada, 2009-10.
    Gold Executive Committee& Gold Science Committee. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Global Initiative for Chronic Obstructive Lung Disease, 2010.
    Gold Executive Committee. Pocket Guide to COPD Diagnosis, Management, and Prevention: A Guide for Healthcare Professionals. Global Initiative for Chronic Obstructive Lung Disease, 2010.
    Dalal, Anand A., Melissa H Roberts, Hans V Peterson, Christopher M Blanchette and Douglas W Mapel. “Comparitive cost-effectiveness of a fluticasone-propionate/salmeterol combination versus anticholinergics as initial maintenance therapy for chronic obstructive pulmonary disease.” International Journal of COPD. 2011:6, 13-22.
    Bateman ED, Hurd SS, Barnes PJ et al. Global strategy for COPD management and prevention: GINA executive summary. Eur Respir J. 2008;31:143-78.
    Sharafkhaneh, Amir, Nancy J. Petersen, Hong-Jen Yu, Anand A. Dalal, Michael L Johnson and Nicola A. Hanania. “Burden of COPD in a government health care system: a retrospective observational study using data from the US Veterans Affair population.” International Journal of COPD. 2010:5 125-132.
    Chen, Andrea M., Suzanne G. Bollmeier and Patrick M Finnegan. “Long- Acting Bronchodilator Therapy for the Treatment of Chronic Obstructive Pulmonary Disease.” The annals of Pharmacotherapy. 2008; volume 42, 1832-1842.
    Blais, Lucie, Jean Bourbeau, Odile Sheehy and Jacques Lelorier. “Inhaled Corticosteroids in COPD: Determinants of use and trends in patient persistence with treatment.” Can Respir Journal. 2004; Vol. 11, No. 1, 27- 32.
    Medications for COPD.2010. Canadian Lung Association.24 Jan. 2011 <http://www.lung.ca/diseases-maladies/copd-mpoc/treatmenttraitement/ medications-medicaments_e.php>.
    Mittmann, N., L. Kuramoto, S.J. Seung, J.M. Haddon, C. Bradely-Kennedy and J.M. FitzGerald. “The cost of moderate and server COPD exacerbations to the Canadian healthcare system.” Respiratory Medicine. 2008; 102, 413-421.
    Chronic Obstructive Pulmonary Disease (COPD).2008. Public Health Agency of Canada.18 Feb. 2011 <http://www.phac.aspc.gc.ca/cd-mc/crdProtocol Version Date: November 12, 2014 Page 46 of 78 mrc/copd-mpoc-eng.php>.
    Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for Diagnosis, Management and Prevention of COPD. Updated on December 2010. Available from http://www.goldcopd.com/Guidelineitem.asp?l1=2&l2=1&intId=989. Accessed on February 16, 2011.
    Régie de l'Assurance Maladie du Québec, Québec Canada. Présentation de la Régie de l'assurance maladie du Québec. Updated on November 2010. Available from http://www.ramq.gouv.qc.ca/fr/publications/documents/depliantscitoye ns/presentation_regie.pdf. Accessed on February 14, 2011.
    Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40:373-83.
    Dalal, Anand A., Meaghan St. Charles, Hans V. Petersen, Melissa H. Roberts, Christopher M. Blanchette and Kathy Manavi-Zievernik. “Costeffectiveness of combination fluticasone propionate-salmeterol 250/50µg versus salmeterol in severe COPD patients.” International Journal of Chronic Obstructive Pulmonary Disease. 2010:5 179-187.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, fluticasone propionate/salmeterol/norflurane, norflurane, salbutamol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    March 2015 to June 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    None
    • 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 (from January 01, 2001 to December 31, 2010);
    • One or more pharmacy claims for tiotropium used for the management of COPD as the primary indication.
    • One or more medical claims with a diagnosis of asthma (ICD-9: 4963xx) between January 01, 2001 and March 31, 2011;
    • 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, pneumoconiosis, pulmonary fibrosis, pulmonary TB, sarcoidosis between January 01, 2001 and March 31, 2011.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 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 (from January 01, 2001 to December 31, 2010);
    • One or more pharmacy claims for tiotropium used for the management of COPD as the primary indication.
    • One or more medical claim with a diagnosis of COPD.
    Exclusion criteria:
    • One or more medical claims with a diagnosis of asthma (ICD-9: 4963xx) between January 01, 2001 and March 31, 2011;
    • 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, pneumoconiosis, pulmonary fibrosis, pulmonary TB, sarcoidosis between January 01, 2001 and March 31, 2011.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
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    Protocol
    Available language(s): English
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    Clinical study report
    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
    2017-06-06
    Actual study completion date
    2017-06-06

    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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