Status: Finalised
First registered on:
10/12/2018
Last updated on:
11/12/2018
1. Study identification
EU PAS Register NumberEUPAS26916
Official titleComparative study of COPD double therapy versus triple therapy: an EGB data analysis
Study title acronym
Study typeObservational study
Brief description of the studyThe primary objective of this study was to define the potential added value of triple therapy compared with double therapy (fixed or free combinations) in real use in COPD patients, in terms of exacerbations, healthcare consumption, related costs and persistence.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsPELyon
Department/Research groupPharmacoEpidemiology Unit
Organisation/affiliationClaude Bernard Lyon 1 University
Details of (Primary) lead investigator
Title Dr
Last name VAN GANSE
First name Eric
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/09/2016
Start date of data collection10/01/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report26/07/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesChiesi100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Dalon
First name Faustine
Address line 1Unité de Pharmacoépidémiologie
Address line 2Faculte d'Odontologie Universite Lyon 1
Address line 311 rue Guillaume Paradin
CityLyon
Postcode69008
CountryFrance
Phone number (incl. country code)33478771024
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Ms
Last name Dalon
First name Faustine
Address line 1Unité de Pharmacoépidémiologie
Address line 2Faculte d'Odontologie Universite Lyon 1
Address line 311 rue Guillaume Paradin
CityLyon
Postcode69008
CountryFrance
Phone number (incl. country code)33478771024
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Chronic obstructive pulmonary disease
8. Population under study
Age
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects3089
Additional information
3,089 patients hospitalized for COPD and aged 45 and over fulfilled the selection criteria.
Of the 3,089 COPD patients included in the study population, 1,538 patients (49.8%) received dual or triple therapy in the two months following inclusion, of whom 1 500 (48.6%) patients had at least 30 days of follow-up available.
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
To compare dual and triple therapies after COPD hospitalizations, on exacerbations, healthcare resource use, costs and persistence.
Are there primary outcomes?Yes
exacerbations
Are there secondary outcomes?Yes
Hospitalization
Medications
Visits to physicians
Medical acts
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Patients were studied from their index date to the end of follow-up, i.e. to the occurrence of a following event, whichever came first: treatment discontinuation, last patient’s health record, death of the patient, or end of the study period.
15. Data analysis plan
Please provide a brief summary of the analysis method
1:1 matching of the 2 cohorts
Matching variables were the following:
o Inclusion year
o Time between inclusion date and index date (+/- 5 days)
o Incidence or not at the combination of dual or triple therapies.
o Propensity score
Propensity score was calculated using a logistic regression model estimating the probability to be treated with a triple therapy, using the following confounding factors calculated in the 12 months before index date:
o Age at inclusion date
o Gender
o CMU-C
o Number of COPD treatments
o Number of exacerbations
o Number of visits to a general practitioner
o Number of visits to a respiratory physician
o Presence/absence of the following comorbidities: cardiovascular diseases, depression, cancer and diabetes
o Use or non-use of oxygen therapy
o Use or non-use of non-invasive ventilation
Comparison using a Wilcoxon test for matched data
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
