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Active, Not Recruiting

NCT Number: NCT07374172

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Asthma Bronchial Diseases COPD Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Small Airway Disease

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Primary care sites across the Netherlands

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: At baseline study visit, during pulmonary function testing

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

Secondary outcomes

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

    Time frame: At baseline study visit, during pulmonary function testing

    To determine whether the bronze model SADT-a is predictive for SAD in COPD.

  2. Develop SADT-c.

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

    Agreement between SADT-c results and disease parameters.

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

    Time frame: At baseline study visit, during pulmonary function testing

    Relative predictive value of SADT-a versus SADT-c for SAD in COPD defined as R5-R20 > ULN1

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

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

    Agreement between triage diagnoses from oscillometry and spirometry. Relative usability of spirometry and oscillometry.

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

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

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

Sponsors and collaborators

Lead sponsor

General Practitioners Research Institute

Network

Registry information

Acronym: SCOOP

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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