Study type

Study topic

Medical procedure

Study type

Non-interventional study

Scope of the study

Method development or testing

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Case-only
Study drug and medical condition

Medical condition to be studied

Chronic obstructive pulmonary disease
Asthma
Asthma-chronic obstructive pulmonary disease overlap syndrome
Population studied

Short description of the study population

The study population for the SCOOP study will consist of patients referred by their General Practitioner (GP) to the Asthma/COPD service. Patients can be referred by their GP when they are suspected to have asthma, Chronic Obstructive Pulmonary Disease (COPD), asthma-COPD overlap (ACO) or when they present with pulmonary symptoms of unknown origin. After referral by the GP, patients will be invited by the Asthma/COPD service. Both patients invited for an initial diagnostic visit or a control visit can participate in the SCOOP study.

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

200
Study design details

Study design

Participants, attending for usual or diagnostic care, will undergo an spirometry and oscillometry test and complete a SADT-c questionnaire. The spirometry and oscillometry reports will be reviewed by a panel of experts (3-5 pulmonologists) for comparison of diagnostic effectiveness.

Main study objective

The primary objective is to determine whether SADT-c can be used in patients with COPD to detect SAD.

Setting

The SCOOP study will be integrated in the visits of the Asthma/COPD service for primary care at the study sites. General Practitioners (GPs) can refer individual patients (>18 years of age) who are suspected to have obstructive airway disease (OAD) such as asthma, Chronic Obstructive Pulmonary Disease (COPD), asthma-COPD overlap (ACO) or present with pulmonary symptoms of unknown origin. Visits can be for initial diagnosis of the OAD or for (yearly) follow-up of the disease.

In order to be eligible to participate in this study, a participant must meet all of the following criteria:
• >35 years or older
• Suspected of having COPD, asthma or ACO as indicated by the referring GP
OR a previous diagnosis of COPD

A potential participant who meets the following criterium will be excluded from participation in this study:
• Inability to understand and sign the written informed consent form.

Outcomes

Primary objective:
The predictive value of SADT-c for detecting SAD in patients with COPD.

Secondary objectives:
- Predictive value of SADT-a bronze model for SAD in COPD.
- Relative predictive value of SADT-a versus SADT-c for SAD in COPD defined as R5–R20 > ULN.
- Agreement between triage diagnoses from oscillometry and spirometry.
- Relative usability of spirometry and oscillometry.

Exploratory objective:
Diagnostic performance of AC/DC tool compared to expert panel diagnosis.

Data analysis plan

See protocol