Asthma-Dx: A platform for investigating novel diagnostic techniques to improve asthma diagnosis in primary care
| ISRCTN | ISRCTN67658695 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67658695 |
| Integrated Research Application System (IRAS) | 358432 |
| Central Portfolio Management System (CPMS) | 71898 |
| Grant Code | NIHR SPCR-2021-2026 751 |
| Sponsor | University of Oxford |
| Funders | Asthma and Lung UK, NIHR School for Primary Care Research |
- Submission date
- 09/02/2026
- Registration date
- 30/04/2026
- Last edited
- 30/04/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Asthma is a lung condition where the airways can become narrowed and inflamed, causing coughing, breathlessness and wheezing, which vary over time. At the moment, there is no single test that can say whether someone has asthma or not, and the diagnosis is made on a combination of the patient’s symptoms and one or more breathing tests (e.g. spirometry), which look for airway narrowing. The problem is that, as asthma symptoms vary, the results may be normal by the time the tests are done. It is known from previous studies that patients find it very frustrating to have lots of tests, none of which provide a final answer, and that undiagnosed asthma can result in long-term lung damage.
This study will investigate how to detect asthma earlier, using new techniques and tests to see how they compare to current methods. It is important to identify asthma promptly so that treatment can be started, both to reduce symptoms and because, without treatment, patients can be at risk of serious asthma attacks.
Who can participate?
Patients aged 18 to 59 years who have symptoms that might be caused by asthma, including coughing, breathlessness, or wheezing and their GP would like further tests to look for potential asthma. Volunteer healthy controls will be invited to participate if they are aged 18 to 59 and do not have any current lung symptoms or suspicion of asthma or other chronic respiratory disease.
What does the study involve?
Patients who contact their GP with symptoms that suggest they might have undiagnosed asthma will be referred to the study. Patients will be included before they start any treatments, as this can affect the results. The study will include questionnaires about symptoms, a consultation with a research GP, in-person assessment including all the usual tests for asthma diagnosis, plus a panel of new tests, and a peak flow diary at home for two weeks, plus new home self-monitoring tests. Healthy volunteers (healthy cohort) with no symptoms will also complete the tests, as the comparison group.
The results in the suspected asthma cohort will be fed back to each participant’s own GP for further treatment as needed. An expert panel will go through results to determine the diagnosis of either likely, unlikely or uncertain asthma based on the ‘usual’ test results. The test results will be compared between likely asthma and healthy cohorts, and new tests vs. usual tests, to see how accurate they are at picking up asthma. A survey and interview will be conducted with a selection of participants and clinicians about how they found the diagnostic tests and study processes.
What are the possible benefits and risks of participating?
There are no necessarily immediate benefits from participation in this study. It is hoped that this study will lead to those who have suspected asthma in the future being able to receive a clearer diagnosis, with less delay.
To work out why participants are experiencing symptoms, they will need to go through some or all of the standard of care tests listed above (approximately 1.5 hours of tests, potentially across several appointments/locations; plus, two-week home monitoring of peak flow), but they are also asked to complete some more tests, which will take more time. The additional time burden linked to the study is about 1-1.5 hours (including the time for the symptom questionnaires and telephone/video consultation) and using an additional test as part of the two-week home monitoring. There is no change to the ongoing treatment, which will be managed in the usual way by their GP practice.
The disadvantage of taking part in research as a healthy volunteer is the time burden. These are tests that they would not normally need to take.
Where is the study run from?
This study is being run from the Nuffield Department of Primary Care Health Sciences, University of Oxford.
When is the study starting and how long is it expected to run for?
April 2026 to December 2026.
Who is funding the study?
1. Asthma Lung UK
2. National Institute for Health and Care Research (NIHR) School for Primary Care Research.
Who is the main contact?
Dr Helen Ashdown, asthma-dx@phc.ox.ac.uk
Contact information
Scientific, Principal investigator
Nuffield Department of Primary Care Health Sciences, Gibson Building, Radcliffe Observatory Quarter, Woodstock Road
Oxford
OX2 6GG
United Kingdom
 ORCID ID |
0000-0002-7758-7095 |
|---|---|
| helen.ashdown@phc.ox.ac.uk |
Public
Nuffield Department of Primary Care Health Sciences, Gibson Building, Radcliffe Observatory Quarter, Woodstock Road
Oxford
OX2 6GG
United Kingdom
| ORCID ID |
0000-0002-8750-8995 |
|---|---|
| Johanna.cook@phc.ox.ac.uk |
Public
Nuffield Department of Primary Care Health Sciences, Gibson Building, Radcliffe Observatory Quarter, Woodstock Road,
Oxford
OX2 6GG
United Kingdom
| ORCID ID |
0009-0008-4754-8619 |
|---|---|
| zhanna.oganesova@phc.ox.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Scientific title | Asthma-Dx: A platform for investigating novel diagnostic techniques to improve asthma diagnosis in primary care (pilot) |
| Study acronym | Asthma-Dx |
| Study objectives | Primary To conduct a mixed-methods evaluation (acceptability and feasibility) of the platform study design Secondary (1) – SA Cohort Only 1) To assess the diagnostic accuracy* of new tests for asthma against standard-of-care diagnosis, alongside novel physiological tests *Or diagnostic potential and informing further research, for earlier-stage tests 2) To assess the acceptability to patients of tests (both standard-of-care and novel tests) and the asthma diagnostic pathway Secondary (2) – SA cohort Only To assess the diagnostic accuracy of clinical history for asthma diagnosis |
| Ethics approval(s) |
Submitted 09/02/2026, London – Riverside Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; riverside.rec@hra.nhs.uk), ref: 26/LO/0110 |
| Health condition(s) or problem(s) studied | Asthma diagnosis in primary care |
| Intervention | Suspected asthma participants will present to their GP Surgery with symptoms suggestive of Asthma. If their GP thinks that they are potentially eligible to take part, they will be told about the study, given a PIS, and their HCP will seek consent to pass on details and health info to the research team by completing a referral form. Healthy volunteers will be identified through advertisements about the study. They will be given a link to the PIS. They can register their interest in taking part in the study through an expression of interest form. All participants will receive a telephone call from the trial team, who will take consent and confirm eligibility to take part and book them into their study visit appointment. They will also be sent a link to complete the baseline questionnaire. For those who have suspected asthma, they will also have a call with a research GP who will record a full consultation with them about their symptoms and medical history. All participants will then complete a face-to-face visit during which they will undergo all standard-of-care diagnostic tests for asthma and also any novel tests being looked at within the pilot, platform study. Details of these tests are listed as appendices to the protocol and PIS and if any are added or removed, an amendment will be submitted to update this. Each test will be analysed individually against the standard of care tests; they will not be assessed against each other. The results of the standard of care tests will be fed back to the GP of the suspected asthma cohort, so that their diagnosis may continue; we will not be involved in the clinical diagnosis of any participants. After this visit, the healthy volunteers involvement is complete. The suspect asthma participants will complete two weeks of home monitoring using a peak flow machine, they will have a GP notes review completed and they will complete a user experience survey. A small group will also take part in the qualitative sub-study. As part of the platform study evaluation, we will conduct qualitative interviews with HCPs who have been involved in recruiting at study sites, to understand their experiences and barriers/facilitators to recruitment, to inform potential continuation beyond a pilot. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 59 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | All: 1. Participant is willing and able to give informed consent for participation in the study 2. Aged 18 to 59 years Suspected Asthma (SA) cohort: 1. Presenting to primary care with symptoms suggestive of asthma e.g. breathlessness and/or wheeze and/or cough where the clinician would normally initiate further investigations for potential asthma |
| Key exclusion criteria | All: 1. Current or ex-smoker (including tobacco, cannabis and e-cigarettes). Having smoked less than 100 cigarettes in their lifetime can be included (as per CDC definition of a never-smoker), provided last smoking was at least a year ago. 2. Pre-existing or previously diagnosed chronic respiratory disease including asthma (resolved diagnoses or previous short-term treatments for asthma or other respiratory disease such as preschool wheeze labelled as asthma are eligible for inclusion) 3. Other current/recent medical condition which affects breathing or the immune system (hay fever/atopy can be included) 4. Current or recent (last 2 weeks) use of oral/long-acting inhaled bronchodilator or steroid or systemic immunosuppression (nasal steroids, or use of short-acting bronchodilators is allowed) 5. Currently pregnant (this is due to the contra-indication to spirometry testing when pregnant, due to physiological changes and forced exhalations resulting from the reduced lung capacity, therefore we will not require formal pregnancy testing before participation) 6. Unstable/severe symptoms and/or any safety concerns which would make diagnostic assessment in a non-clinical research setting inappropriate for them or the research staff. Healthy control cohort: As above for ‘All’ and: 1. Current respiratory symptoms or suspicion of asthma or other chronic respiratory disease diagnosis 2. Childhood diagnosis of asthma or other chronic respiratory problems in childhood, including preschool wheeze |
| Date of first enrolment | 01/04/2026 |
| Date of final enrolment | 30/09/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
-
-
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Helen Ashdown, helen.ashdown@phc.ox.ac.uk, anonymised IPD data will be shared following publication of the final paper and the companies we are working with receiving their relevant data, data will be shared for ethically approved (if applicable) research projects for systematic review or similar types of analysis, via secure electronic data transfer. |
Editorial Notes
09/02/2026: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
