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Active, not recruitingNCT07374172SCOOPUpdated Jan 28, 2026

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

An observational study in Asthma, COPD and Small Airway Disease, sponsored by General Practitioners Research Institute. Active, not recruiting at 1 site in Netherlands. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by General Practitioners Research Institute · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
108
Ages
35 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Asthma
  • COPD
  • Small Airway Disease

Keywords

  • SADT-c
  • Oscillometry
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In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 108 is below the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

General Practitioners Research Institute is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Cross-sectional
Enrollment
108 participants (actual)
Patient registry
No

Groups and cohorts

  • Participants with Small Airway Disease

    Diagnostic Test: Oscillometer ALDS

  • Participants without Small Airway Disease

    Diagnostic Test: Oscillometer ALDS

Interventions

  • Diagnostic testOscillometer ALDS

    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.

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What researchers measure

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.

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

Secondary outcomes

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

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

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

  2. Develop SADT-c.

    Agreement between SADT-c results and disease parameters.

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

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

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

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

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

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

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

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

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

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

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Study locations

1 site
  • Primary care sites across the Netherlands
    Groningen, Netherlands
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07374172
Lead sponsor
General Practitioners Research Institute
Responsible party
Sponsor
First posted
Jan 28, 2026
Start date
May 1, 2024
Primary completion
Aug 1, 2025
Completion
Jun 2026 (estimated)
Last update
Jan 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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