An exploratory study to assess the effect of benralizumab on small airway obstruction in patients with severe asthma using functional respiratory imaging

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Patients eligible for treatment with benralizumab will be aged 18 - 75 years and have a confirmed diagnosis of severe eosinophilic asthma according to ERS/ATS guidelines.
Pre-bronchodilator FEV1 of ? 80% predicted and history of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1.
All patients will show persistent blood eosinophilia of >0.3 x 10E9/L despite treatment with high doses of inhaled corticosteroids (>500 ug/day fluticasone equivalent), or >0.15 x 10E9/L despite chronic oral corticosteroid treatment at baseline.
At least 2 documented asthma exacerbations in the 12 months prior to the date informed consent.
Females of childbearing potential must have a negative pre-treatment urine pregnancy test.
Subjects are allowed to use their own inhalation therapy during this study.
Subjects who are steroid dependent and maintained on an equivalent of =10 mg oral prednisone per day for at least 3 months prior to Visit 1 are eligible, providing the dose of oral steroids remains stable during the run-in period.

Exclusion Criteria

Current smokers or former smokers with a smoking history of =15 pack years. A former smoker is defined as a subject who quit smoking at least 6 months prior to Visit 1
Chronic pulmonary disorders other than asthma
Current malignancy or previous malignancy in remission <12 months
Prior use of anti IL5 or anti IL5 Receptor monoclonal Antibodies. For patients treated with omalizumab there is a wash out period of 3 month.
Any other condition that, according to the investigator, may affect the outcome of the study

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to investigate the effect (and the onset of this effect) of benralizumab on specific Functional Respiratory Imaging parameters in patients with severe eosinophilic asthma after 4 and 12 weeks treatment.

Secondary Outcome Measures

Name	Time	Method
The secondary objectives are to investigate if there is an relationship between other FRI outcomes and also clinical parameters such as lung function, dyspnoea and exercise tolerance.