Poor Response to Monoclonal Therapy in Asthma

Asthma Clinical Trial

— PROCLAIM  

Official title:

Investigating Poor Response to Monoclonal Therapy in Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04114396
• Other study ID #: 18048
• Status: Recruiting
• Start date: December 31, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: November 2020
• Source: University of Nottingham
• Contact: Yik L Pang, BMedSci, MBBS, MRCP
• Phone: 01158231702
• Email: mszyp[@]exmail.nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Exclusion criteria: control participants:

• Pregnancy

• Underlying respiratory conditions

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Anti-IL5 Antibody
Asthma group: Anti-IL5 treatment Control group: No biologic.

Procedure:
• Bronchoscopy
Optional for both arms

Locations

Country	Name	City	State
United Kingdom	Nottingham Respiratory BRU	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	A clinically meaningful improvement in asthma control as assessed by ACQ	An improvement in FEV1 of >100ml using spirometry.	12 months
Secondary	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
Secondary	The identification of exacerbation pathogenesis in patients receiving anti-IL5 therapy via viral throat swab analysis	Viral throat swabs results (using Cepheid Rapid device) will be analysed at ad-hoc exacerbation visits to identify exacerbation pathogenesis.	12 months