Efficacy and safety study of benralizumab added to medium dose inhaled corticosteroid plus LABA in patients with uncontrolled asthma

• Conditions: Asthma; MedDRA version: 16.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-002352-32-DE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-30
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 846

Inclusion Criteria

Provision of informed consent prior to any study specific procedure
Female and male aged 18-75 years, inclusively
History of physician diagnosed asthma requiring medium dose ICS (greater than 250 microgrammes fluticasone dry powder formulation equivalents total daily dose and a LABA for at least 12 months prior to Visit 1
Documented treatment with medium dose ICS (> 250 microgrammes and = 500 microgrammes fluticasone dry powder formulation equivalents total daily dose) and a LABA for at least 3 months prior to Visit 1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alphs 1 anti trypsin deficiency and primary ciliarydyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophillic syndrome).
Any disorder including, but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric or major physical impairement that is not stable in the opinion of the investigator and could - affect the safety of the patient throughout the study-influence the findings of the studies or their interpretations-impede the patients ability to complete the entire duration of the study.
Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run in period.
Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry or urinalysis during screening/run in period, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patients ability to complete the entire duration of the study

Study & Design

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