Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics (NCT03953300) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
United States75 participantsStarted 2019-10-08
Plain-language summary
The purpose of the study is to evaluate effect of benralizumab on structural and lung function changes in severe eosinophilic asthmatics.
Changes will be assessed over 48 week treatment period in patients with persistent symptoms despite standard therapy of inhaled corticosteroids (ICS) plus long acting B2-agonist (LABA) with or without additional controller medication.
Patients who complete treatment will enter 4 weeks follow-up period.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female aged 18 through 70 years.
✓. Physician-diagnosed asthma requiring continuous treatment with medium- or high-dose ICS plus LABA with or without additional controller medication for at least 12 months prior to Visit 1, and current treatment with high-dose ICS plus LABA for at least 3 months prior to Visit 1 with or without additional asthma maintenance medication.
✓. Morning pre-BD FEV1 ≥50 to \<80% of predicted normal value (PNV) and ≥1 liter (L) or morning pre-BD FEV1 ≥ 50 to \< 90% of PNV, if historical pre-BD FEV1 value (within 12 months prior to screening visit) was \< 80% of PNV.
✓. A blood eosinophil count meeting any of 3 criteria: ≥300 cells/µL during screening or ≥ 220 to \< 300 cells/μL during screening and documented eosinophil count of ≥ 300 cells/μL in the past 12 months, or ≥150 to \<300 cells/µL during screening plus one of the following: presence of nasal polyps or pre-BD FVC \<65% predicted at Visit 2
✓. Negative pregnancy test.
✓. Asthma control questionnaire (ACQ-6) \>1.5.
✓. Fewer than 12 exacerbations within the 6 months prior to Visit 3.
Exclusion criteria
✕. Any disease or concomitant medication which could affect study results or safety of study participants, including:
✕. Use of chronic immunosuppressive medication or receipt of immunoglobulin (or blood products) within 30 days prior to the date informed consent is obtained.
✕
What they're measuring
1
The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
Timeframe: From baseline to Week 48 (Visit 10)
2
The change in airway wall area percentage as the overall median for airway generations 3 and 4 combined as measured by quantitative computed tomography (QCT) imaging