An observational study in Asthma (Diagnosis), sponsored by George Eliot Hospital. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by George Eliot Hospital · Observational
Among 558 studies in Asthma with a site in United Kingdom — 52 open to participants now, 72 under way, 11 of them phase 3. Asthma · United Kingdom.
Among the 558 studies in Asthma with a site in United Kingdom, this one is the 17th largest by planned enrollment of the 131 observational ones, is one of 17 that started in 2026, is one of 131 observational ones, reaches primary completion later than 54 of the 71 other live ones, and was the 555th registered.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 2,176 is above the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →52 of the 558 studies in Asthma with a site in United Kingdom are open now, in 12 countries. Each count lists the studies.
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.
This study: 16 Years and older · all sexes · healthy volunteers too.
The full table on the hub →558 studies; the count open now beside each. This study's row is marked.
First in 1991; this study’s year is marked. 17 started in 2026.
Median enrollment 69 across the 427 interventional studies, 149 across the 131 observational. Of the 444 that completed or were terminated, 155 (35%) have results posted.
320 of 558 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with George Eliot Hospital as lead sponsor.
George Eliot Hospital has 1 study filed under Asthma — fewer than ten, so there is no comparison to draw.
23 of the studies in Asthma with a site in United Kingdom that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05692180Phase 3AstraZenecaA Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma | 2026-12-23 |
| NCT07645248Phase 3GlaxoSmithKlineA Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a) | 2026-12-28 |
| NCT06473779Phase 3AstraZenecaOpen-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. | 2027-06-25 |
| NCT07833826University of NottinghamN-WATCH: Nottingham Wheeze Assessment in Tidal Children | 2026-12-31 |
| NCT07488897RIGImmune Inc.RIG 101 Trial in Healthy Adults and Adults With Asthma | 2027-02 |
Among the 558 studies in Asthma with a site in United Kingdom, from their registry updates:
Asthma is a common long-term condition that can be difficult to diagnose accurately. Symptoms such as breathlessness, wheeze and cough can vary over time and may be caused by other conditions. Some people with asthma have normal breathing test results when they are assessed, which can make diagnosis challenging and lead to delays in treatment.
This study aims to determine which commonly used tests, either alone or in combination, are most accurate for diagnosing asthma in adults with suspected disease. Participants referred to George Eliot Hospital for investigation of possible asthma will be invited to take part.
Following informed consent, participants will undergo a range of routine diagnostic tests during their first visit. These include spirometry with bronchodilator response testing in patient with both normal airway function and airflow obstruction, fractional exhaled nitric oxide (FeNO), which measures airway inflammation, and oscillometry, which assesses how air moves through the lungs. Participants will then attend a second visit for a bronchial provocation challange test, which helps determine whether the airways are unusually sensitive, a key feature of asthma.
The study will compare the results of these tests with the final diagnosis to assess how accurately each test identifies or excludes asthma. It will also investigate whether combining different tests improves diagnostic accuracy and whether factors such as obesity affect diagnostic measurements of increased asthma prevalence.
The findings will help improve understanding of the most effective ways to diagnose asthma in routine clinical practice. This may lead to faster and more accurate diagnoses, reduce the need for unnecessary investigations, and support better care for people with suspected asthma.
Potential participants will be identified from adults referred to the Physiological Sciences Department at George Eliot Hospital NHS Trust for objective investigation of suspected asthma through routine primary or secondary care referral pathways. Eligible participants will be assessed by the research team. Only patients who provide written informed consent will be enrolled into the study. Following consent, the lead researcher will access relevant electronic healthcare records to collect the clinical information required for the study, as described in the consent form. Study data will be assigned a unique pseudonymised study identification number and stored securely, password-protected, on the Trust's systems. Access to identifiable information will be restricted to authorised members of the research team in accordance with the UK GDPR, the Data Protection Act 2018 and NHS information governance policies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
•Adults aged 16years and older
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo standardised pre-bronchodilator spirometry using a calibrated spirometer operated by trained study personnel. Measurements will include forced expiratory volume in one second (FEV₁), forced vital capacity (FVC), slow vital capacity (SVC), peak expiratory flow (PEF) and the FEV₁/FVC ratio. Participants will perform at least three acceptable forced expiratory manoeuvres, with the highest reproducible values recorded. Spirometry will be conducted at the protocol-specified study visit(s) to assess pulmonary function as an outcome measure. Testing will follow current international quality control and acceptability standards.
Participants will undergo FeNO measurement using a calibrated nitric oxide analyser operated by trained study personnel. The test will be performed according to standardised international guidelines using a controlled exhalation at a constant flow rate. FeNO values, expressed in parts per billion (ppb), will be recorded to assess airway inflammation. Measurements will be obtained at protocol-specified study visit(s) under standardised testing conditions, with quality control procedures followed throughout testing.
Participants will undergo bronchodilator response testing to assess for airway responsiveness in both obstructive and normal patients. Spirometry will be performed before and after administration of a standardised dose of an inhaled short-acting bronchodilator delivered via a metered-dose inhaler with a spacer. Post-bronchodilator spirometry will be conducted after the protocol-specified waiting period. Changes in forced expiratory volume in one second (FEV₁), forced vital capacity (FVC), and other spirometric parameters will be recorded according to standardised international guidelines. Testing will be performed by trained study personnel using calibrated equipment.
Participants will undergo respiratory oscillometry using a calibrated oscillometry device operated by trained study personnel. Measurements will be obtained during quiet tidal breathing according to standardised international guidelines. Respiratory impedance parameters, including airway resistance (e.g., R5, R20), reactance (e.g., X5), resonant frequency (Fres), and area of reactance (AX), will be recorded. At least three acceptable measurements meeting quality control criteria will be obtained. Testing will be performed at protocol-specified study visit(s) under standardised conditions to assess respiratory mechanics.
Participants will undergo a standardised bronchial provocation challenge to assess airway hyperresponsiveness. Increasing doses of a bronchial provoking agent will be administered according to a standardised protocol under the supervision of trained study personnel. Spirometry will be performed after each dose to measure changes in forced expiratory volume in one second (FEV₁). The test will continue until a predefined decline in FEV₁ is achieved or the maximum protocol dose is reached. Testing will be performed using calibrated equipment with continuous monitoring and appropriate safety procedures, following current international guidelines.
Primary outcome measure- Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, and Area Under the ROC Curve of Combined First-Line Objective Testing for Asthma Diagnosis
Diagnostic performance of combined first-line objective investigations (fractional exhaled nitric oxide \[FeNO\], oscillometry, spirometry, and bronchodilator reversibility testing) compared with the composite reference standard incorporating bronchial provocation testing. Diagnostic performance will be assessed using sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve (AUC).
Time frame: 6 weeks
Secondary out come measure - Number and Proportion of Participants Requiring Bronchial Provocation Testing Following First-Line Assessment
Number and proportion of participants who require bronchial provocation testing to confirm or exclude a diagnosis of asthma following completion of the first-line objective investigations.
Time frame: 6 weeks
Diagnostic Concordance Between First-Line Objective Investigations and the Composite Reference Standard
Diagnostic concordance between FeNO, oscillometry, spirometry, and bronchodilator reversibility testing and the composite reference standard incorporating bronchial provocation testing for the diagnosis of asthma.
Time frame: 6 weeks
Diagnostic Performance of First-Line Objective Investigations According to Obesity Status
Diagnostic performance of FeNO, oscillometry, spirometry, and bronchodilator reversibility testing compared with the composite reference standard, stratified according to obesity status using BMI, using the following categories: \<18.5 18.5-24.9 25-29.9 30-34.9 35-39.9 \>40
Time frame: 6 weeks
Diagnostic Performance of First-Line Objective Investigations in Participants With Preserved Baseline Spirometry
Diagnostic performance of FeNO, oscillometry, and bronchodilator reversibility testing compared with the composite reference standard among participants with preserved baseline spirometry.
Time frame: 6 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Feb 2028, 18 months after the start.
Of 364 non-industry observational studies under Asthma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 97. This study's planned 18 months is below that.
Counting every sponsor, half of 454 studies reached it within 36 months; a quarter within 18 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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