Benralizumab in Severe Asthma

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; Severe Eosinophilic Asthma; MedDRA version: 21.1Level: LLTClassification code 10068462Term: Eosinophilic asthmaSystem Organ Class: 100000004855

• Registration Number: EUCTR2019-003763-22-GB
• Lead Sponsor: Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-26
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

•Male or female patients aged 18 to 75 years with severe GINA defined asthma
•Taking a medium to high dose of ICS/LABA OR high dose ICS with another second line controller (BDP equivalent dose of =800µg) of step 4/5 GINA therapy.
•Established diagnosis of persistent asthma for at least 6 months according to GINA guidelines. Diagnosis should have been properly documented at the screening visit, based on medical documentation and medical history.
•Uncontrolled asthma as per ACQ6 = 1.5
•Forced Expiratory Volume in 1 second (FEV1) = 50% predicted.
•Mannitol PD10 = 635mg at screening and Visit 1
•Patients with or without nasal polyposis
•Eosinophilic asthma as evidenced by
oEos =300 cells/µl at screening visit or within 6 months prior to screening OR
oEos =150 cells/µl at screening visit or within 6 months prior to screening with nasal polyps OR
oEos = 150 cells/µl with late onset asthma or fixed airflow obstruction.
•Ability to give informed consent.
•Agreement for their GP to be made aware of study participation and to receive feedback as relevant to the participant’s well being.
•Able to understand the study procedures and the risks involved.
•Good physical and mental status, determined on the basis of the medical history and a general clinical examination at screening.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

•Previously been treated with benralizumab.
•Any other respiratory diseases such as COPD and moderate to severe bronchiectasis which in the opinion of the investigator are considered to be clinically significant and may have an impact on the study outcomes. Patients with Asthma COPD Overlap (ACO) may be included providing they meet all the other criteria.
•Active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases).
•Any known systemic (e.g., blood, liver, kidney, etc.) clinically significant medical condition, known significant laboratory abnormalities or communicable disease that may endanger the health or safety of the patient.
•Asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month prior to screening visit or 3 months if hospital admission was required.
•Any disorder that is not stable in the opinion of the Investigator.
•Patients who are participating in the clinical phase of another interventional trial or have done so within the last 30 days or within 5 half-lives of the previous administered product (whichever is longer) before screening. Individuals who are participating in the follow-up phase of another interventional trial, or who are enrolled in an observational study, will be co-enrolled where the Coordinating Investigator of each study agree that it is appropriate.
•Female patients who are pregnant or lactating.
•Patients unable or unwilling to consent.
•Patients taking non-permitted medications.
•Patients with a history of hypersensitivity to any of the study medications components or a history of other allergy that in the opinion of the investigator contraindicates the patient’s participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified