SADT in COPD and Oscillometry in Obstructive Airway Disease in Primary Care. The SCOOP-study

NCT07374172 | Active Not Recruiting

• 1 other identifier: GPRI-2024-002
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: 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.

Conditions

Small Airway Disease; Asthma; COPD

Keywords

SADT-c; Oscillometry

Outcome Measures

Primary Outcomes (1)

• The predictive value of SADT-c for detecting SAD in patients with COPD.

  To determine whether SADT-c can be used in patients with COPD to detect SAD.

  At baseline study visit, during pulmonary function testing

Secondary Outcomes (5)

• Predictive value of SADT-a bronze model for SAD in COPD.

  At baseline study visit, during pulmonary function testing

• Develop SADT-c.

  At baseline study visit, using data collected during pulmonary function testing and clinical assessment

• To evaluate how SADT-c compares to SADT-a.

  At baseline study visit, during pulmonary function testing

• To determine whether oscillometry and spirometry are equally effective for triage diagnosis in patients in primary care with respiratory symptoms.

  At baseline study visit, during initial diagnostic assessment in primary care

• Assess the diagnostic performance of the Asthma/COPD Differentiation Classification (AC/DC) Tool.

  At baseline study visit, with expert panel diagnosis based on data collected during the study assessment

Study Arms (2)

Participants with Small Airway Disease

Diagnostic Test: Oscillometer ALDS

Participants without Small Airway Disease

Diagnostic Test: Oscillometer ALDS

Interventions

Oscillometer ALDS DIAGNOSTIC_TEST

Oscillometry is a non-invasive technique for assessing lung function, as it requires only 45-60 seconds of tidal breathing to measure the mechanical properties of the respiratory system. This makes the measurement suitable for patients of all ages and with severe respiratory conditions. It also reduces the number of errors as compared to other methods (e.g., spirometry). Oscillometry can be used to evaluate airway resistance, reactance, and compliance, insights that are challenging to obtain with other methods. This quality makes oscillometry especially sensitive for obstructive diseases like asthma and COPD, and correlations with physiological small airways dysfunction have also been shown . The Ambulatory Lung Diagnosis System (ALDS), manufactured by Lothar MedTec, can be used to perform oscillometry and spirometry. The ALDS follows the European Respiratory Society (ERS) technical standards for measurement and reporting of oscillometry.

Participants with Small Airway Disease; Participants without Small Airway Disease

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Suspected of having COPD, asthma or ACO as indicated by the referring GP OR a previous diagnosis of COPD

You may not qualify if:

• Inability to understand and sign the written informed consent form.

Sponsors & Collaborators

• General Practitioners Research Institute: lead

Study Sites (1)

Primary care sites across the Netherlands

Groningen, Netherlands

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 28, 2026
• Study Start: May 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)