Benralizumab and lung micro-organisms (BALM)

Phase 1

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

• Registration Number: EUCTR2017-003665-10-GB
• Lead Sponsor: Royal Brompton and Harefield NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-28
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Age 18-75 years
2.Weight =40kg
3.Severe asthma as defined in the 2014 ERS/ATS severe asthma guideline
4.Deemed eligible to commence benralizumab as NHS treatment according to NICE TA565
5.FEV1 = 60% predicted
6.ACQ-6 >1.5.

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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1.Significant cardiac disease, e.g. ischaemic heart disease, cardiac failure, permanent pacemaker
2.Pregnant and breastfeeding
3.Significant respiratory disease, other than the condition being studied, e.g. chronic obstructive pulmonary disease, interstitial lung disease, obstructive sleep apnoea requiring treatment.
4.Current malignancy
5.Current smokers (All subjects must be non-smokers or ex-smokers for at least 12 months with <10 pack-years smoking history.)
6.Obesity (BMI>35kg/m2)
7.Rheumatoid arthritis
8.Confounding drugs (anti-asthma immune modulators other than steroids)
9.Treatment with a monoclonal antibody in the last 6 months
10.Known history of allergy or reaction to the study drug formulation, or history of anaphylaxis to any biologic therapy.
11.Long-term systemic antibiotics/ antifungals, or any course(s) of systemic antibiotics/ antifungals within the past 2 weeks.
12.Acute exacerbations of asthma (defined as a clinical episode requiring treatment with systemic corticosteroids, or requiring an increase in the dosage of systemic corticosteroids if the patient is on long term corticosteroid treatment) within the past 2 weeks
13.History of an upper or lower respiratory infection (including common cold) within the past 2 weeks
14.Female subjects who are pregnant/ breastfeeding/ less than 6 weeks post-partum at the time of enrolment, or who fulfil any of these criteria at any point prior to the final investigation (bronchoscopy)
15.Previous bronchial thermoplasty in the last 48 months.
16.Unable to provide written informed consent.

Study & Design

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