Profiling Inhalation Medication in COPD patients (PRIME)

Study identification

• EU PAS number:
  EUPAS32862
• Study ID:
  32863
• Official title and acronym:
  Profiling Inhalation Medication in COPD patients (PRIME)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  (Inter) national guidelines advise that the prescription of pharmacological treatment should be individualized. Several tools have been created to assist and guide physicians in the selection of the most suitable inhalation treatment for COPD patients. Nevertheless, it is unclear which patient characteristics guide pulmonologists in their decisions of the prescription of inhalation medication in COPD patients.Therefore, this study aims to describe the key patient characteristics that guided pulmonologists’ prescription of inhalation medication in primary care COPD patients, using decision tree modelling.In 2007, an asthma/COPD(AC)-service was implemented in the North of the Netherlands to support general practitioners (GPs). In this system, pulmonologists support GPs in the diagnosis of their patients through an internet-based diagnostic dialogue. Patients complete questionnaires at home including the Clinical COPD Questionnaire (CCQ), the Asthma Control Questionnaire (ACQ) and medical history including allergies, medication use and smoking history. Spirometry and BMI measurement is performed by a technician of a laboratory. Pulmonologists see the data online through a protected website and send the GP a working diagnosis and treatment advice.We will include all COPD patients from the Asthma/COPD-service (AC-service) of whom medication advice has been given by the AC services pulmonologist between 2007 and 2017. The Chi-squared Automatic Interaction Detection (CHAID) method will be used to build the decision tree. The patient characteristics that will be used to develop the decision tree can be divided into three different categories: patients characteristics (e.g. age, gender, GOLD category), patient-reported outcomes (e.g. CCQ, ACQ), and spirometry outcome measures (e.g. FEV1, FVC, reversibility)
• Study status:
  Ongoing

Research institutions and networks

Institutions

General Practitioners Research Institute (GPRI)

Netherlands

Study timelines

Date when funding contract was signed

Actual:22/11/2018

Study start date

Actual:03/12/2018

Date of final study report

Planned:31/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim bv

Regulatory

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