Severe Eosinophilic Asthma MedDRA version: 21.1 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Fasenra
Product Name: Fasenra
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Benralizumab
CAS Number: 1044511-01-4
Other descriptive name: Fasenra
Concentration unit: mg/
Sponsors
Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside
Eligibility
Sex/Gender
All
Inclusion criteria
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 o Eos =300 cells/µl at screening visit or within 6 months prior to screening OR o Eos =150 cells/µl at screening visit or within 6 months prior to screening with nasal polyps OR o Eos = 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of benralizumab on airway hyper-responsiveness (AHR), after 3 months of treatment, measured by mannitol challenge as the provocative dose causing a 10% fall in forced expratory volume in 1 second (FEV1) (PD10 Mannitol), from post-run-in baseline in severe eosinophilic asthma.;Secondary Objective: • To assess the effect of benralizumab on AHR, after 3 months of treatment, measured by Mannitol RDR, from post run-in baseline in severe eosinophilic asthma • To assess changes in type 2 biomarkers: FeNO, blood eosinophils, ECP and EDN after 3 months of treatment with benralizumab • To assess the effect of benralizumab on pulmonary function tests: spirometry and impulse oscillometry • To assess changes in patient reported outcomes: ACQ6; domiciliary PEF, symptoms and reliever use after 3 months of treatment with benralizumab • To assess what happens to AHR, type 2 biomarkers, pulmonary function tests and patient reported outcomes after stopping benralizumab for three months ;Primary end point(s): Change in mannitol PD10 from Visit 1 (post-run-in baseline) to Visit 5 ;Timepoint(s) of evaluation of this end point: From Visit 1 (post run-in baseline) to Visit 5, following 3 doses of benralizumab treatment (12 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in mannitol RDR FeNO Blood Eosinophils ECP EDN ACQ6 Diary cards for PEF, symptom (morning value only) and reliever use (number of puffs) Spirometry Impulse oscillometry (IOS) ;Timepoint(s) of evaluation of this end point: Above end points will be evaluated from Visit 1(post-run-in baseline) to Visit 5. Also evaluate the change in mannitol PD10 and RDR from Visit 5 (end of treatment) to Visit 6 (follow-up visit) The change in FeNO, blood eosinohpils, ECP, EDN, ACQ6, diary cards for PEF, symptom (morning value only) and reliever use (number of puffs), spirometry and IOS from Visit 5 (end of treatment) to Visit 6 (follow-up visit) will also be evaluated. | — |
Countries
United Kingdom
Outcome results
None listed