Asthma-Dx: A platform for investigating novel diagnostic techniques to improve asthma diagnosis in primary care (pilot)
Asthma diagnosis in primary care
Current methodology as of 11/05/2026: 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. Primary analyses will assess each test individually against the reference standard. 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 pa
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
Current exclusion criteria as of 11/05/2026: 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 regular use of an inhaled steroid/long-acting bronchodilator or systemic immunosuppression (nasal steroids, or use of short-acting bronchodilators is allowed). Where possible, we will wait 6 weeks post-oral steroid course before diagnostic testing, as is recommended in clinical guidelines, unless there is a relevant clinical reason to do this sooner, as determined by the PI/usual GP. 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 Previous 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