Experience of Biologic Treatments for Severe Asthma: a Survey

NCT06903780 | Recruiting

• 2 other identifiers: 2502729CPMS ID: 60193
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Severe Asthma

Keywords

asthma; survey; patient perspectives; patient centred; co-development; multi-centre

Outcome Measures

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

  6-18 month recall

Interventions

Survey using a questionnaire. OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• Receiving a biologic treatment for at least 6 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• 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

Study Sites (1)

Royal Devon University Healthcare NHS Foundation Trust

Exeter, Devon, EX2 5DW, United Kingdom

RECRUITING

Related Links

• Website with information concerning this project and other projects conducted by this team

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Matthew Masoli, MD

  Royal Devon and Exeter NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Lanario, PhD

CONTACT

+44 01752 764403; joseph.lanario@plymouth.ac.uk

Alison Kerridge, PhD

CONTACT

+44 01392 403055; alison.kerridge@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: January 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 27, 2025

Record last verified: 2024-11

Locations

GB (1)