AsthmaSCOOPNCT07374172
SADT in COPD and Oscillometry in Obstructive Airway Disease in Primary Care. The SCOOP-study
An observational study of Asthma and COPD, run by General Practitioners Research Institute at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Asthma, COPD, Small Airway Disease
- What is being tested?
- Oscillometer ALDS
- How many people
- 108 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2024to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Suspected of having COPD, asthma or ACO as indicated by the referring GP OR a previous diagnosis of COPD
Who cannot join
- Inability to understand and sign the written informed consent form.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Asthma, COPD, Small Airway Disease
- Being tested
- Oscillometer ALDS
- Keywords
- SADT-c, Oscillometry
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oscillometer ALDSDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Small Airway Disease | Not described Receives: Diagnostic Test: Oscillometer ALDS | |
| Participants without Small Airway Disease | Not described Receives: Diagnostic Test: Oscillometer ALDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline study visit, during pulmonary function testing
Secondary outcomes (5)
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.
Measured: At baseline study visit, during pulmonary function testing
Develop SADT-c.
Agreement between SADT-c results and disease parameters.
Measured: At baseline study visit, using data collected during pulmonary function testing and clinical assessment
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
Measured: 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.
Agreement between triage diagnoses from oscillometry and spirometry. Relative usability of spirometry and oscillometry.
Measured: At baseline study visit, during initial diagnostic assessment in primary care
Assess the diagnostic performance of the Asthma/COPD Differentiation Classification (AC/DC) Tool.
Diagnostic performance of AC/DC tool compared to expert panel diagnosis.
Measured: At baseline study visit, with expert panel diagnosis based on data collected during the study assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 May 2024
- Primary completion1 Aug 2025
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Practitioners Research Institute
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374172
- Sponsor's protocol ID
- GPRI-2024-002
- Acronym
- SCOOP
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SADT in COPD and Oscillometry in Obstructive Airway Disease in Primary Care. The SCOOP-study
- ClinicalTrials.gov ID
- NCT07374172
- Acronym / sponsor ID
- SCOOP / GPRI-2024-002
- Conditions
- Asthma, COPD, Small Airway Disease
- Keywords
- SADT-c, Oscillometry
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- General Practitioners Research InstituteResearch network
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Small Airway Disease | – | Diagnostic Test: Oscillometer ALDS |
| Participants without Small Airway Disease | – | Diagnostic Test: Oscillometer ALDS |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Suspected of having COPD, asthma or ACO as indicated by the referring GP OR a previous diagnosis of COPD
Key exclusion criteria (1 listed)
- Inability to understand and sign the written informed consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oscillometer ALDSOscillometry 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. | Diagnostic test | Participants with Small Airway Disease, Participants without Small Airway Disease |
Primary outcome
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.
5 secondary outcomes
Predictive value of SADT-a bronze model for SAD in COPD.
Time frame: At baseline study visit, during pulmonary function testing
Develop SADT-c.
Time frame: At baseline study visit, using data collected during pulmonary function testing and clinical assessment
To evaluate how SADT-c compares to SADT-a.
Time frame: 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.
Time frame: At baseline study visit, during initial diagnostic assessment in primary care
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and COPD, run by General Practitioners Research Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predictive value of SADT-c for detecting SAD in patients with COPD. (time frame: At baseline study visit, during pulmonary function testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.