An observational study in Severe Asthma, sponsored by Royal Devon and Exeter NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Royal Devon and Exeter NHS Foundation Trust · Observational
Severe asthma is a disease characterised by respiratory and non-respiratory symptoms. The respiratory symptoms can include breathlessness, wheeze and asthma attacks. The disease can come to dominate patients' lives, impacting their social, working and personal lives, leading to depression, anxiety and feelings of social isolation.
There are now 7 different biologic treatments available on the NHS in the UK for severe asthma. These treatments have dramatically changed how severe asthma can be treated. Research has typically focused on the benefits of these drugs from a clinical perspective, e.g., improvements in lung function, blood tests and reduction in frequency of asthma attacks and use of steroid tablets.
While these are important outcomes, they do not reflect the experiences of patients receiving these treatments, which can vary greatly. First, not all patients benefit to the same degree. Second for patients who do respond, some respond slower than others. Third while these treatments target respiratory symptoms, some patients report wider benefits, such as reductions in fatigue, depression, ability to engage in family life and other daily activities. Fourth, patients report different side effects when starting these treatments and sometimes for months afterwards, including headaches, fatigue, mental fog and joint pain. These experiences are reported by clinicians and patients, but the extent of these four variations is poorly understood, and potential reasons for them have not been explored.
To describe these differences between patients' experiences and begin understanding why they are present, we have co-designed a survey with people who have lived experience of severe asthma who are members of the European Lung Foundation's (ELF) Patient Advisory Group (PAG). This process has resulted in a survey that contains content important to patients and is worded in a way that avoids confusion regarding the meaning of the questions.
A multi-centre cross-sectional survey to retrospectively assess patients' perceptions of their responses to biologic treatments for their severe asthma.
Methods A total of 400 patients will be recruited from the severe asthma centres responsible for their clinical care.
Leads from each participating site will identify patient's eligible to take part in the study. Each lead for a site will be provided with unique 'Collector IDs' (that are linked with a unique survey web URL). After receiving verbal consent from each patient, the researcher at the site will allocate the patient a 'Collector ID' and unique web URL to a survey hosted on SurveyMonkey.
On visiting the survey URL, patients will be provided with study information, provide informed consent and complete the survey information.
Participants will complete the survey without any assistance from physicians or the study staff. All survey questions and responses will be provided in the participants' native languages. All processes will be monitored by a study coordinator to assess recruitment and the completion of the survey.
Variables
Variables from the patient survey will include:
Experience of starting a biologic treatment
o What changed, when did the change take place and to what degree was the change experienced.
Use of biologic treatment Data analysis
1. To describe the time course and nature of response in people with severe asthma who continue to be prescribed biologics for between 6 - 18 months.
To assess for the presence of recall differences between those who have been on a biologic for \<12 months vs those on a biologic for ≥12 months data from these participants will be stratified and compared.
2. To identify subgroups of response pattern to biologic treatments for severe asthma.
Analysis will be exploratory and descriptive, with relationships between survey responses identified through correlations. These correlations will provide insight into which experiences of biologic treatment (response) are related. For example, the literature anticipates that a fast response will be associated with a "better" response to biologic treatments. We will define "better" from a patient perspective, by investigating the relationship between Question 8 (Satisfaction with treatment), and time to first noticed treatment response (Question 6).
3. To describe the characteristics of the different subgroups of response pattern.
Participants demographic data will be reported as a function of the different response patterns we identify in analysis 2.
4. To identify a set of hypotheses driven characteristics which may predict response to biologics in future longitudinal studies for people with severe asthma, including the extra-pulmonary symptoms and side effects of treatment.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 400 is above the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →Royal Devon and Exeter NHS Foundation Trust is the lead sponsor of 63 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient has severe asthma as defined by :
GINA step 4 \& 5 Moderate to high dose ICS and a LABA or LTRI or LAMA (theophylline)
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.
Receiving a biologic treatment for at least 6 months.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A short 23-item survey concerning patients' experiences of their biologic treatments for their severe asthma.
Severe asthma biologic experience survey
A 23-item survey concerning the experiences of severe asthma patients who have received a biologic treatment. This survey covers many aspects of experience from: Degree of response Time to respond Benefits first noticed - pulmonary and extra-pulmonary Changes to other medications Side effects HRQoL improvement
Time frame: 6-18 month recall
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Royal Devon and Exeter NHS Foundation Trust