Poor Response to Monoclonal Therapy in Asthma
- Conditions
- Asthma
- Interventions
- Drug: Anti-IL5 AntibodyProcedure: Bronchoscopy
- Registration Number
- NCT04114396
- Lead Sponsor
- University of Nottingham
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Severe asthma Anti-IL5 Antibody Untreated by anti-IL5 treatment for severe asthma at point of recruitment. To be prescribed anti-IL5 as part of their treatment following consent. Note: Anti-IL5 treatment is prescribed as per agreed multidisciplinary team meeting, outside of the decision to enrol the patient on the study, and is administered by the clinical team as part of the patient's clinical care outside of the research study. Healthy control Bronchoscopy Control group without respiratory condition Severe asthma Bronchoscopy Untreated by anti-IL5 treatment for severe asthma at point of recruitment. To be prescribed anti-IL5 as part of their treatment following consent. Note: Anti-IL5 treatment is prescribed as per agreed multidisciplinary team meeting, outside of the decision to enrol the patient on the study, and is administered by the clinical team as part of the patient's clinical care outside of the research study.
- Primary Outcome Measures
Name Time Method A clinically meaningful improvement in asthma control as assessed by ACQ 12 months An improvement in FEV1 of \>100ml using spirometry.
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).
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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Nottingham Respiratory BRU
🇬🇧Nottingham, United Kingdom