1. Study identification
EU PAS Register NumberEUPAS4207
Official titleOutpatient care with long-acting bronchodilators:
Study title acronymDACCORD
Study typeObservational study
Brief description of the studyThe DACCORD registry aims to close the apparent gap between populations in clinical trials and daily live by evaluating different treatment approaches in COPD with respect to their efficacy and tolerability and their impact on patient-related outcomes. DACCORD is a prospective observational German registry since November 2012, evaluating data of 16,000 COPD patients from approximately 700 sites distributed in three different cohorts.
To guarantee the best selection under the conditions of a non-interventional study, patients have to fulfill the criteria for recruitment to the German COPD DMP (Disease Management Program), implemented by the statutory health insurances. The primary objective is to evaluate diagnosis and therapy of outpatient-treated COPD patients under special consideration of individual treatment success, determined by therapy adherence, symptoms and patient-reported outcomes. Among the secondary objectives are the characteristics of exacerbations and COPD progression, measured by lung function and CAT (COPD Assessment Test) questionnaire
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 applicableCNVA237ADE01
2. Research centres and Investigator details
Coordinating study entity
Centre nameNovartis Pharmaceuticals
Centre locationBasel, Switzerland
Details of (Primary) lead investigator
Title Ms
Last name Clinical Disclosure Officer
First name Novartis
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?700
Countries in which this study is being conducted
National study
Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/06/2012
Start date of data collection05/11/2012
Start date of data analysis01/06/201514/03/2021
Date of interim report, if expected01/11/201525/01/2019
Date of final study report01/02/202227/10/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNovartis Pharmaceuticals100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Clinical Disclosure Officer
First name Novartis
Address line 1Novartis Pharmaceuticals
Address line 2CH-4002
Address line 3
CityBasel
Postcode
CountrySwitzerland
Phone number (incl. country code)416132-41111
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Ms
Last name Clinical Disclosure Officer
First name Novartis
Address line 1Novartis Pharmaceuticals
Address line 2CH-4002
Address line 3
CityBasel
Postcode
CountrySwitzerland
Phone number (incl. country code)41613241111
Alternative phone number
Fax number (incl. country code)41713248001
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 (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects16000
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Prospective patient-based data collection
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Drug utilisation study
Effectiveness evaluation
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
The DACCORD registry will be able to provide insights into the real world efficacy and safety of long-acting bronchodilators in the management of COPD.
Are there primary outcomes?Yes
The primary objective is to describe the diagnosis and treatment of patients with COPD while paying special attention to the individual treatment outcome, as measured by treatment
compliance, symptoms and patient-related endpoints. The following therapies will be observed: glycopyrronium bromide therapy versus an established Disease Management Program
(DMP) versus therapy with LABA/LA
Are there secondary outcomes?Yes
Among the secondary objectives are the characteristics of exacerbations (rate, severity and time to first) and COPD progression, measured by lung function and CAT (COPD Assessment Test) questionnaire.
13. Study design
What is the design of the study?
Non-interventional study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Up to 2 years
15. Data analysis plan
Please provide a brief summary of the analysis method
Systematic group differences with respect to prognostic factors must be anticipated in a non-randomized study, leading to distortion from confounding. In order to still permit comparisons between the two study arms, propensity score stratification will be performed. A detailed description will be provided in a separately written statistical analysis plan (SAP); the risk factors to be included therein are still to be defined. The all-documented patient group covers all patients with at least one entry in the eCRF. The analyses will be differentiated, modeled on randomized clinical trials using the ITT (intend-to-treat) and PP (per-protocol) population. All the parameters recorded will be analyzed descriptively. The qualitative data will be analyzed using absolute values and percentages, and the continuous variables presented in in a final statistical report using median and quartile values.