Treatable Traits in patients with Obstructive Lung Diseases in Dutch primary care

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105402
• EU PAS number:
  EUPAS105378
• Study ID:
  105402
• Official title and acronym:
  Treatable Traits in patients with Obstructive Lung Diseases in Dutch primary care
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  Clinical guidelines for the management of obstructive lung diseases recommend a stepwise approach for treatment of asthma and COPD, but there is increasing realisation that a more personalised approach targeting “treatable traits” may be effective in achieving better control of these heterogeneous diseases. The Dutch asthma/COPD service (AC-service) supports general practitioners by diagnosing and monitoring patients with obstructive lung disease in a standardised way. Data collected within this framework offer a unique opportunity to quantify the frequency and stability of treatable traits among patients with obstructive lung disease. ; ; Objectives: ; A. To estimate the prevalence of eight treatable traits and the amount of overlap between these traits in patients with obstructive lung disease in Dutch general practice ; B. To study the stability of treatable traits and the effect of management advice on changes in traits and health status in patients with obstructive lung disease who were assessed at a follow-up visit in Dutch general practice ; ; Study design: A database study will be performed using data collected for the Asthma/COPD (AC)-service from patients with obstructive lung disease between 2007 and 2022. The presence (or absence) of eight treatable traits will be assessed at the patient’s first attendance to the AC-service. The stability of treatable traits and the effect of management advice on this and on health status will be assessed in patients who were followed-up by the service. ; ; Study population: Patients attending the AC-service who were ≥18 years of age at the first AC-service attendance with a (working) diagnosis of asthma, COPD or Asthma-COPD overlap (ACO). ; ; Analyses will be performed in: ; 1. The total study population of patients with a (working) diagnosis of asthma, COPD or Asthma-COPD overlap (ACO). ; 2. (Mutual exclusive) subpopulations of patients with a (working) diagnosis of: a) Asthma b) COPD c) Asthma-COPD overlap (ACO)
• Study status:
  Finalised

Research institutions and networks

Institutions

General Practitioners Research Institute (GPRI)

Netherlands

Study timelines

Date when funding contract was signed

Planned: 27/01/2023

Actual: 27/01/2023

Study start date

Planned: 27/01/2023

Actual: 01/02/2023

Date of final study report

Planned: 14/01/2024

Actual: 31/10/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GSK

Regulatory

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