SADT in COPD and Oscillometry in obstructive airway disease in primary care (SCOOP-study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000183
• EU PAS number:
  EUPAS1000000183
• Study ID:
  1000000183
• Official title and acronym:
  SADT in COPD and Oscillometry in obstructive airway disease in primary care (SCOOP-study)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  The Small Airways are a major site of obstruction in many respiratory diseases, including COPD. More insight into a diagnosis of Small Airways Dysfunction (SAD) in patients with COPD is clinically valuable as it might enable tailored pharmacotherapy. Currently, methods to diagnose SAD in COPD are not standardized and are not available in routine clinical practice. The Small Airways Dysfunction Tool (SADT) was developed to identify patients with asthma and SAD. Initially, the SADT included a comprehensive 63-item questionnaire. The number of items has been reduced to a SADT-asthma (SADT-a) questionnaire and key patient and disease characteristics for it to be feasible and implementable in clinical practice. Although there are many similarities between asthma and COPD, there might be differences in clinical characteristics and responses to small airways dysfunction between the two diseases. ; The current study aims to adapt the original 63-item SADT questionnaire for dedicated use in COPD by reducing the number of items, and identifying COPD-SAD-specific items, to enhance its efficiency in identifying SAD when combined with key patient and disease characteristics in individuals with COPD (SADT-c). In addition, a comparison of diagnostic accuracy of spirometry and oscillometry will be made by interpretations by a panel of experts to provide a triage diagnosis. The previously developed machine learning AC/DC tool will be used to explore its diagnostic accuracy using oscillometry and spirometry results. This can contribute to standardizing oscillometry in clinical practice.
• Study status:
  Planned

Research institutions and networks

Institutions

General Practitioners Research Institute (GPRI)

Netherlands

Study timelines

Date when funding contract was signed

Planned: 01/02/2024

Actual: 01/02/2024

Study start date

Planned: 15/06/2024

Data analysis start date

Planned: 01/09/2024

Date of final study report

Planned: 31/12/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Chiesi Farmaceutici S.p.A.

Study protocol

Initial protocol

C1.Research_Protocol_Scoop_v1_19apr2024.pdf

Regulatory

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