A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service

Asthma Clinical Trial

— REMISSION UK  

Official title:

A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06261567
• Other study ID #: D2287R00189
• Status: Recruiting
• Start date: February 27, 2024
• Est. completion date: September 27, 2024

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Asthma is a common lung condition that causes occasional breathing difficulties and affects around 5.4 million people in the UK of all ages. Common symptoms can include wheezing when breathing, breathlessness, a tight chest and coughing. However, these symptoms can get worse and lead to an asthma attack which can be fatal.

There is currently no cure for asthma but there are treatments that can help keep the symptoms under control. The main types of treatment include reliever inhalers used when needed quickly to reverse asthma symptoms for a short time, and preventer inhalers that are used everyday to prevent symptoms for starting. Unfortunately, not all patients are able to control their asthma on these treatments alone. Biologic treatments, also known as monoclonal antibodies, have been introduced to treat certain types of severe asthma over recent years. These specialist treatments use antibodies produced from cells in a laboratory to help reduce inflammation and might offer the possibility of higher levels of disease control including the reduction or absence of symptoms and normal lung function. This higher level of disease control is called remission.

This study aims to understand whether or not remission is possible in patients with severe asthmas treated with biologics in the NHS. This study will take place a 4 specialist asthma centres in the UK and seeks to include retrospective data from approximately 450 adult patients that were treated with biologics as part of routine care between 01 October 2021 and 30 September 2022. Data will be collected directly from medical records and entered into the study database in a pseudonymised format by members of the direct care team ready for analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 425
• Est. completion date: September 27, 2024
• Est. primary completion date: September 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• Initiated on a biologic treatment for SA between 1st October 2021 and 30th September 2022

• Patients who received =1 dose of biologic treatment

• Patients aged =18 years at index

Exclusion Criteria:

• Patients who were involved in any interventional clinical trial during the study period (+/- 12 months from index).

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Biologic treatment
Patients receiving treatment with any biologic treatment for severe asthma which is approved within the UK NHS. These include omalizumab, mepolizumab, reslizumab, benralizumab and/or dupilumab

Locations

Country	Name	City	State
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients in clinical remission	Proportion of patients with zero exacerbations, zero mOCS use and ACQ <1.5	12 months
Primary	Number and proportion achieving specific criteria for clinical remission	Number and proportion achieving the following criteria for clinical remission: any 1 criterion; any 2 criteria; any 3 criteria; exacerbation AND maintenance oral corticosteroids (mOCS) criteria; exacerbation, mOCS, AND asthma symptom control criteria	12 months
Primary	Number and proportion of super-responders		12 months
Primary	Number and proportion of responders		12 months
Primary	Number and proportion of non-responders		12 months
Secondary	Age at index		Index (first dose of biologic)
Secondary	Sex		Index (first dose of biologic)
Secondary	Ethnicity		Index (first dose of biologic)
Secondary	Smoking status		Index (first dose of biologic)
Secondary	BMI		Index (first dose of biologic)
Secondary	IMD quintile		Index (first dose of biologic)
Secondary	Comorbidities		Index (first dose of biologic)
Secondary	COVID-19 vaccination status		Index (first dose of biologic)
Secondary	Fractional Exhaled Nitric Oxide (FeNO)		Index (first dose of biologic)
Secondary	Blood eosinophil count (EOS)		Index (first dose of biologic)
Secondary	IgE		Index (first dose of biologic)
Secondary	ACQ-6		Index (first dose of biologic)
Secondary	AQLQ		Index (first dose of biologic)
Secondary	lung function (FEV1)		Index (first dose of biologic)
Secondary	Rate of exacerbation in prior 12 months		Index (first dose of biologic)
Secondary	Asthma treatments at 6 months		6 months
Secondary	Asthma treatments at 12 months		12 months
Secondary	Annualised exacerbation rate (AER)		6 months
Secondary	mOCS use (proportion with 0 mg/day)		6 months
Secondary	ACQ-6 score		6 months
Secondary	AQLQ score		6 months
Secondary	Lung function (FEV-1)		6 months
Secondary	Respiratory infections		6 months
Secondary	Annualised exacerbation rate (AER)		12 months
Secondary	mOCS use (proportion with 0 mg/day)		12 months
Secondary	ACQ-6 score		12 months
Secondary	AQLQ score		12 months
Secondary	Lung function (FEV-1)		12 months
Secondary	Respiratory infections		12 months