Experience of Biologic Treatments for Severe Asthma: a Survey

ConditionSevere Asthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Devon and Exeter NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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 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)

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Survey using a questionnaire.

    Other intervention

    A short 23-item survey concerning patients' experiences of their biologic treatments for their severe asthma.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royal Devon and Exeter NHS Foundation Trust

Lead sponsor

University of Plymouth

Collaborator

University Hospital Plymouth NHS Trust

Collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

Collaborator

University Hospital Birmingham

Collaborator

Barts Helth NHS Trust

Collaborator

Guy's and St Thomas' NHS Foundation Trust

Collaborator