Asthma
Conditions
Keywords
Severe Asthma, Anti-IL5, Asthma
Brief summary
Asthma affects 8% of the entire population. 4-5% of asthma sufferers have severe asthma, characterised by recurrent exacerbations (worsening of symptoms leading to the person having a bout of corticosteroids and/or antibiotics), significant symptoms and lack of response to the most widely used therapy, corticosteroids. There is now new types of treatments (antibody drugs) which are licensed to manage severe asthma such as Anti-IL5. There is evidence Anti-IL5 and other similar antibody drugs are effective at reducing asthma exacerbations and reduce the need for oral corticosteroids for those that have severe asthma. However, some patients respond poorly to Anti-IL5 and the investigators would like to find out why this happens. It is hoped that the investigators can identify the mechanism of poor treatment response to Anti-IL5. It is also hoped that the investigators can understand why symptoms worsen to the point of requiring antibiotics and/or steroids (also known as an exacerbation) for those prescribed Anti-IL5.
Interventions
DRUGAnti-IL5 Antibody
Asthma group: Anti-IL5 treatment Control group: No biologic.
PROCEDUREBronchoscopy
Optional for both arms
Sponsors
University of Nottingham
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
case participants: * Aged 18 - 80 years old * Able to give informed consent * All patients identified as being suitable for anti-IL5 therapy by the asthma MDT will be considered for study enrolment. This assessment by the MDT for participants to be eligible includes: * A measure of compliance with current asthma medication, * Confirmation of asthma diagnosis * Suitability for anti-IL5 therapy based on blood eosinophil counts, * Asthma exacerbation rates * Prednisolone dose. * Confirmation of treatment requires at least two asthma specialists to agree that this is the correct course of action * Patients must first demonstrate over 75% compliance with inhaled and/or oral corticosteroid therapy The asthma MDT and difficult asthma clinic normally assess patients between 18-80 years so only patients in this age range will be approached. All patients will be able to give informed consent for study participation.
Exclusion criteria
case participants: • Pregnancy Inclusion criteria: control participants: * Aged between 18-80 years old. * Able to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of mechanisms associated with poor response to anti-IL5 therapy | 12 months | Identification of mechanisms associated with poor response to anti-IL5 therapy. A poor response is defined as an inability to halve the pre-treatment annualised exacerbation rate; an asthma exacerbation is defined as a worsening of asthma symptoms necessitating a short burst of oral corticosteroids, or a doubling of maintenance oral corticosteroid treatment dose. |
| An improvement in FEV1 as assessed by spirometry | 12 months | Treatment response as assessed as a clinically meaningful improvement in asthma control (ACQ change of \>0.5). |
| A clinically meaningful improvement in asthma control as assessed by ACQ | 12 months | An improvement in FEV1 of \>100ml using spirometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The identification of exacerbation pathogenesis in patients receiving anti-IL5 therapy via cytokine analysis | 12 months | Blood cytokine analysis (analysed by Bio-plex 200 system) will be analysed at ad-hoc exacerbation visits to identify exacerbation pathogenesis. |
| The identification of exacerbation pathogenesis in patients receiving anti-IL5 therapy via viral throat swab analysis | 12 months | Viral throat swabs results (using Cepheid Rapid device) will be analysed at ad-hoc exacerbation visits to identify exacerbation pathogenesis. |
Countries
United Kingdom
Contacts
Primary ContactYik L Pang, BMedSci, MBBS, MRCP
Backup ContactMohammad R Ali, BSc, MRes
Outcome results
None listed