Outpatient care with long-acting bronchodilators: COPD Register in Germany (DACCORD)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  All consecutive patients with COPD should be considered for study enrolment in line with the inclusion criteria if they are receiving established antiobstructive drugs or glycopyrronium bromide after undergoing treatment modification or being started on treatment. In all events the treating doctor must make the therapeutic decision prior to the patient being documented in the Register. ; The resulting inclusion criteria are:; • Written consent of the patient to participation in the study; • Age: ≥ 40 years; • Diagnosis of COPD by a doctor; • Initiation or modification of pharmacological COPD treatment at the start of the study (visit 0); • Recruitment to the COPD DMP or fulfilment of the DMP inclusion criteria; ; Enrolled patients should be monitored for at least two years, hence foreseeable difficulties with following up on a patient entail an exclusion criterion.; The following additional exclusion criteria are to be noted:; • Recruitment to DMP Asthma bronchiale; • Ongoing participation in a randomised clinical trial
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Chronic obstructive pulmonary disease (COPD) patients
• Estimated number of subjects:
  16000

Study design details

• Main study objective:
  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.
• Outcomes:
  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, 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.
• Data analysis plan:
  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.