Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe asthma | 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 | Control group without respiratory condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-IL5 Antibody | Drug | Asthma group: Anti-IL5 treatment Control group: No biologic. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of mechanisms associated with poor response to anti-IL5 therapy | 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. | 12 months |
| An improvement in FEV1 as assessed by spirometry | Treatment response as assessed as a clinically meaningful improvement in asthma control (ACQ change of >0.5). | 12 months |
| A clinically meaningful improvement in asthma control as assessed by ACQ | An improvement in FEV1 of >100ml using spirometry. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The identification of exacerbation pathogenesis in patients receiving anti-IL5 therapy via cytokine analysis | Blood cytokine analysis (analysed by Bio-plex 200 system) will be analysed at ad-hoc exacerbation visits to identify exacerbation pathogenesis. | 12 months |
| The identification of exacerbation pathogenesis in patients receiving anti-IL5 therapy via viral throat swab analysis |
Not provided
Inclusion criteria: case participants:
This assessment by the MDT for participants to be eligible includes:
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:
Exclusion criteria: control participants:
Not provided
Not provided
Participants will be recruited from the severe asthma clinic. Once the multidisciplinary team (MDT) have decided that the patient will be prescribed anti-IL5 therapy a patient information sheet (PIS) will be posted out by the clinical team. If the appointment with the clinical team is within days of the MDT, potential participant will be approached by a member of the research team and the study will be discussed and a patient information sheet will be given to the patient.
Control participants will be recruited from our Respiratory Research Database and have agreed to be contacted for research. A poster will be created to be put up in Nottingham City Hospital, Queen's Medical Centre and at the University of Nottingham, UK.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yik L Pang, BMedSci, MBBS, MRCP | Contact | 01158231702 | mszyp@exmail.nottingham.ac.uk | |
| Mohammad R Ali, BSc, MRes | Contact | 07812268393 | mohammad.ali@nottingham.ac.uk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham Respiratory BRU | Recruiting | Nottingham | NG51PB | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
Not provided
Not provided
Not provided
Not provided
Not provided
| Bronchoscopy |
| Procedure |
Optional for both arms |
|
Viral throat swabs results (using Cepheid Rapid device) will be analysed at ad-hoc exacerbation visits to identify exacerbation pathogenesis. |
| 12 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |