Biomarkers of asthma remission after tezepelumab treatment

Not Applicable

• Conditions: Severe asthma; Respiratory; Asthma

• Registration Number: ISRCTN75982397
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-12
• Last Update Posted: 26 August 2024
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

1. Adult (=18 years old)
2. Clinical decision to initiate tezepelumab for severe asthma after meeting licensing, local and national guidelines
3. Be able to give valid written consent; compliant with study procedures and study visits

Exclusion Criteria

1. Known hypersensitivity to the active substance of tezepelumab or any of the excipients
2. Participation in an interventional clinical trial within 3 months of visit 1 or receipt of any investigational medicinal product within 3 months or 5 half-lives. Participation in other observational studies is acceptable if in the view of the investigator it will not impact the study outcomes
3. Other clinically significant medical disease or uncontrolled concomitant disease that is likely, in the opinion of the investigator, to require a change in therapy or impact the ability to participate in the study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Adequacy of asthma control and change in asthma control measured using the Asthma Control Questionnaire 5 Questions (ACQ5) <1.5, assessed at 1 year<br>2. Pulmonary function measured using post-bronchodilator (post BD) Forced Expiratory Volume in 1 Second (FEV1) percent predicted, at 1 year<br>3. Exacerbations history, assessed using medical history at 1 year<br>4. Oral corticosteroids use, assessed using medical history and current medications at 1 year