Severe AsthmaSHARP EoBNCT06903780
Experience of Biologic Treatments for Severe Asthma: a Survey
An observational study of Severe Asthma, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Asthma
- What is being tested?
- Survey using a questionnaire.
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient has severe asthma as defined by : GINA step 4 \& 5 Moderate to high dose ICS and a LABA or LTRI or LAMA (theophylline)
Who may be able to join
- Receiving a biologic treatment for at least 6 months.
- But has not been on the treatment for longer than 18 months. Note: In clinical practice, a 12-month trial of biologic treatments is needed before a decision to stop/switch treatment is made. Therefore, our inclusion criteria will capture people who are non-responders to biologic treatments.
Who cannot join
- Patients will be excluded if they are unwilling/unable to provide consent to use their data.
- Patients who have switched biologics will also be excluded.
- In the opinion of the physician responsible for the care of the patient, the patient has a condition, other than asthma which is significantly contributing to their respiratory symptoms, e.g. lung cancer, heart failure or severe COPD.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Devon University Healthcare NHS Foundation Trust
Exeter, Devon, EX2 5DW
Joseph Lanario, PhD, 01752 764403, joseph.lanario@plymoyth.ac.uk
About this study
Official title: A Retrospective Survey Of The Time Course And Nature Of The Experience Of Initiating Biologic Treatment For People With Severe Asthma.
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.
Read more
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.
Read the detailed description
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
- What changed, when did the change take place and to what degree was the change experienced.
- Side effects experienced after taking a biologic treatment. Demographics
- Gender
- Age Medication use
- Use of OCS
- Use of biologic treatment Data analysis
- 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.
- Demographics data and other survey responses will be reported as descriptive statistics including mean (SD).
- We will report a frequency distribution of responses for each survey item to describe the samples experience of biologic drugs for their severe asthma.
- 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.
- 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).
- 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.
- 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.
- Fatigue and other side effects from biologics may be predictors of fast response or high satisfaction with treatment.
- Correlations between the different response patterns identified in analysis 2, and questions concerning side effects and extra-pulmonary questions will be calculated. These include questions: 17, 18 and 19.
- We will also calculate correlations between the response patterns we identify in analysis 2, and the biologic the patient was prescribed.
- Conditions
- Severe Asthma
- Being tested
- Survey using a questionnaire.
- Keywords
- asthma, survey, patient perspectives, patient centred, co-development, multi-centre
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey using a questionnaire.Other
A short 23-item survey concerning patients' experiences of their biologic treatments for their severe asthma.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-18 month recall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Jan 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Plymouth, University Hospital Plymouth NHS Trust, Newcastle-upon-Tyne Hospitals NHS Trust, University Hospital Birmingham, Barts & The London NHS Trust, Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Matthew Masoli, MD, Principal investigator, Royal Devon and Exeter NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903780
- Sponsor's protocol ID
- 2502729
- Other IDs
- CPMS ID: 60193
- Acronym
- SHARP EoB
- Status last verified
- Nov 2024
- First submitted
- 25 Mar 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Survey Of The Time Course And Nature Of The Experience Of Initiating Biologic Treatment For People With Severe Asthma.
- ClinicalTrials.gov ID
- NCT06903780
- Acronym / sponsor ID
- SHARP EoB / 2502729
- Conditions
- Severe Asthma
- Keywords
- asthma, survey, patient perspectives, patient centred, co-development, multi-centre
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Plymouth, University Hospital Plymouth NHS Trust, Newcastle-upon-Tyne Hospitals NHS Trust, University Hospital Birmingham, Barts & The London NHS Trust, Guy's and St Thomas' NHS Foundation Trust
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- What changed, when did the change take place and to what degree was the change experienced.
- Side effects experienced after taking a biologic treatment. Demographics
- Gender
- Age Medication use
- Use of OCS
- Use of biologic treatment Data analysis
- 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.
- Demographics data and other survey responses will be reported as descriptive statistics including mean (SD).
- We will report a frequency distribution of responses for each survey item to describe the samples experience of biologic drugs for their severe asthma.
- 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.
- 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).
- 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.
- 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.
- Fatigue and other side effects from biologics may be predictors of fast response or high satisfaction with treatment.
- Correlations between the different response patterns identified in analysis 2, and questions concerning side effects and extra-pulmonary questions will be calculated. These include questions: 17, 18 and 19.
- We will also calculate correlations between the response patterns we identify in analysis 2, and the biologic the patient was prescribed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient has severe asthma as defined by : GINA step 4 \& 5 Moderate to high dose ICS and a LABA or LTRI or LAMA (theophylline)
Key inclusion criteria (2 listed)
- Receiving a biologic treatment for at least 6 months.
- But has not been on the treatment for longer than 18 months. Note: In clinical practice, a 12-month trial of biologic treatments is needed before a decision to stop/switch treatment is made. Therefore, our inclusion criteria will capture people who are non-responders to biologic treatments.
Key exclusion criteria (3 listed)
- Patients will be excluded if they are unwilling/unable to provide consent to use their data.
- Patients who have switched biologics will also be excluded.
- In the opinion of the physician responsible for the care of the patient, the patient has a condition, other than asthma which is significantly contributing to their respiratory symptoms, e.g. lung cancer, heart failure or severe COPD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey using a questionnaire.A short 23-item survey concerning patients' experiences of their biologic treatments for their severe asthma. | Other | – |
Primary outcome
Severe asthma biologic experience survey
Time frame: 6-18 month recall
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Website with information concerning this project and other projects conducted by this teamLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Masoli, MD principal investigator
Royal Devon and Exeter NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Lanario, PhD (+44 01752 764403, joseph.lanario@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe asthma biologic experience survey (time frame: 6-18 month recall). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.