Non-interventional, cross-sectional, multicenter study to describe the exacerbations profile of COPD patients Treated with ICS in a real-life primary care population in Spain. OPTI Study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39847
• EU PAS number:
  EUPAS22940
• Study ID:
  39847
• Official title and acronym:
  Non-interventional, cross-sectional, multicenter study to describe the exacerbations profile of COPD patients Treated with ICS in a real-life primary care population in Spain. OPTI Study
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  This study has been designed in order to describe the COPD patient profile of patients treated with or without ICS in primary care, in Spain. Primary objective: To describe the patient profile for patients treated with ICS at the time of study visit. Secondary objectives: a) To describe the patient profile for patients not treated with ICS at the time of study visit. b) To assess the proportion and the number (count) of patients with COPD treated with ICS at the time of study visit with or without moderate-to-severe exacerbations, both in the previous 1 year and previous 2 years before the study visit. c) To assess the proportion and the number (count) of patients with COPD not treated with ICS at the time of study visit with or without moderate-to-severe exacerbations, both in the previous 1 year and previous 2 years before the study visit. d) Use of rescue medication. e) Adherence to treatment recommendations according GesEPOC guidelines. f) To describe ICS-related adverse events. The design of the study impose an only visit to be performed that will coincide with one of those performed by the patients as part of routine follow-up of their disease, without interfering with usual clinical practice of the investigator. Approximately 1,000 patients with COPD are planned to be included in the study in 200 sites. To minimize selection bias at the patient level, the first 5 consecutive patients from each site who met all inclusion criteria and none of the exclusion criteria will be enrolled during one year. Data will be obtained from patient medical records and during the study visit. Most of data will be available in the charts but as a routine clinical practice, some data could be missing. Data will be collected through an eCRF which will include all the study variables. CAT – COPD Assessment Test will be filled in by the patient during the study visit and data will be entered electronically into the CRF system by the Investigator.
• Study status:
  Finalised

Research institutions and networks

Institutions

University Hospital Vall d’Hebron (HUVH)

Spain

Multiple centres: 200 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 09/02/2018

Actual: 09/02/2018

Study start date

Planned: 18/07/2018

Actual: 21/09/2018

Data analysis start date

Planned: 04/05/2020

Actual: 02/06/2020

Date of final study report

Planned: 18/01/2021

Actual: 09/02/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim España, S.A

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable