An interventional study of FEV1 in Asthma, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-12-03.
Sponsored by Imperial College London · Not applicable, Interventional, and Diagnostic
The purpose of this study is to investigate exacerbations in severe asthma with regard to symptoms, lung function, aetiology and biomarkers.
Patients will be recruited from the Severe Asthma Clinics at Royal Brompton Hospital. At the first visit the investigators will enrol and characterise patients. This will involve asking patients to keep a diary record of PEFR(Peak Expiratory Flow Rate), spirometry, symptom scores, use of beta-agonist reliever and other treatments for 2 weeks. Bloods tests will be taken for markers of systemic inflammation. Markers of oxidative stress will be measured in blood, exhaled breath condensate (EBC) and urine: malondialdehyde (MDA) and 8-isoprostanes. Nitric oxide (NO) levels in exhaled breath will be measured measured twice daily for 2 weeks using a portable hand-held NO meter. If spontaneous sputum is not available, sputum will be induced using ultrasonic nebulization of isotonic saline. Profile of inflammatory cells, cytokines in supernatants, bacteriological culture and microbiome analysis will be measured in the sputum. Patients will be observed over 12 months during which time the number of exacerbations will be recorded on basis of objective measures with evaluation of ACQ (Asthma Control Questionnaire), daily morning and evening PEF (Peak Expiratory Flow). At the earliest onset of exacerbation, the patient will be requested to contact the Asthma Research Unit. Patients will then be asked to attend the laboratory where similar tests to the first visit will be performed. For other exacerbations not studied, the patient will be asked to keep a detailed diary record of symptoms with severity scoring and spirometric and PEF measurements (Exacerbation Diary) over a period of 2 weeks after onset of exacerbation.
As patients with severe asthma are usually very well experienced in what the symptoms of exacerbations are, they will therefore be asked to recognise their own exacerbations. Each patient has their own way of recognising an exacerbation and the investigators will discuss this with each patient and try and establish whether an earlier warning signal is possible. Patients will be asked to record their symptoms and lung function as soon as they feel the onset of an exacerbation, since exacerbations are recognised by the patient as events that are 'clinically identified by being outside the patient's usual range of day-to-day variation'. The patient will receive or administer treatments for the exacerbation as usual without interference from the Research Team except for starting any antibiotic therapies, which will be started (if prescribed) as soon as the visit studies have been completed. Those who have been hospitalized will not be studied, and only those who can attend the Clinical Research Unit will be studied.
3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 25 is below the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients must be able to give informed consent. The definition of severe asthma will be on the basis of
Uncontrolled asthma: three or more of the following features present in any week in the previous 4 weeks:
Exclusion Criteria:
Current smoker, or Ex-smoker with a >10 year pack history or having smoked within the past 6 months
Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
Diagnostic Test: FEV1
Participants have FEV1 test
Percent Predicted FEV1
From date of screening visit until date of first asthma exacerbation visit Percent predicted Forced Expiratory Volume in First Second
Time frame: Baseline Visit, 12 months
Exhaled Breath Condensate
pH and free Iron
Time frame: Baseline Visit, 12 months
Markers of Oxidative Stress in Urine
malondialdehyde (MDA)
Time frame: Baseline Visit, 12 months
Markers of Oxidative Stress in Urine
8-isoprostanes
Time frame: Baseline Visit, 12 months
Sputum Analysis
Eosinophils as percentage of total count
Time frame: From baseline visit and 12 months
PCR for Respiratory Viruses
nasopharyngeal swabs
Time frame: Baseline Visit, 12 months
Sputum Microbiome
Time frame: Baseline Visit, 12 months
Corticosteroid Insensitivity in Peripheral Blood Mononuclear Cells
Time frame: Baseline Visit, 12 months
Exhaled Nitric Oxide
Time frame: Baseline Visit, 12 months
Exhaled Hydrogen Sulphide
Time frame: Baseline Visit, 12 months
| Milestone | Severe Asthma |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
From date of screening visit until date of first asthma exacerbation visit Percent predicted Forced Expiratory Volume in First Second
| % of predicted value | Severe Asthma |
|---|---|
| baseline | 58.6 ± 20.4 |
| During exacerbation | 56.3 ± 22.2 |
pH and free Iron
No measurements were reported for this outcome.
malondialdehyde (MDA)
Results for this outcome have not been posted.
8-isoprostanes
Results for this outcome have not been posted.
Eosinophils as percentage of total count
| Percentage of total sputum counts | Severe Asthma |
|---|---|
| Baseline | 10.9 ± 30.6 |
| At exacerbation | 4.47 ± 9.47 |
nasopharyngeal swabs
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Severe Asthma | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Continuous(years) | Severe Asthma |
|---|---|
| Mean | 55.9 ± 11.5 |
| Sex: Female, Male(Participants) | Severe Asthma |
|---|---|
| Female | 17 |
| Male | 8 |
| Race and Ethnicity Not Collected(Participants) | Severe Asthma |
|---|
| Region of Enrollment(participants) | Severe Asthma |
|---|---|
| United Kingdom | 25 |
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Plan to share: No
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Imperial College London