Study to investigate the Potential Effect of Benralizumab on the antibody response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients with Severe Asthma (ALIZE)
- Conditions
- AsthmaMedDRA version: 19.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-001717-24-Outside-EU/EEA
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active
- Sex
- All
- Target Recruitment
- 100
1. Written informed consent/assent as appropriate with local guidance for study
2. Female and male patients aged 12 to 21 years, inclusively
3. Documented history of current treatment with ICS and LABA. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 µg/day fluticasone propionate dry powder formulation or equivalent daily
4. Women of childbearing potential (WOCBP) must use an effective form of birth
control (confirmed by the Investigator)
5. All male patients who are sexually active must agree to use a double barrier method of
contraception (condom with spermicide) from the first dose of IP until 16 weeks after
their last dose
6. Weight of =40 kg
7. Evidence of asthma as documented by either:
– Airway reversibility (FEV1 =12% and 200 ml) demonstrated at Visit 1 or Visit 2
using the Maximum Post-bronchodilator Procedure OR
– Airway reversibility documented in the previous 12 months prior to Visit 1
8. Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) of >50%
predicted at Visit 1 or Visit 2
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Clinically important pulmonary disease other than asthma (eg, active lung infection,
bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome)
2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment 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 patient’s ability to complete the entire duration of study
3. Any clinically significant abnormal findings in physical examination, vital signs, baseline ECG, hematology, clinical chemistry, or urinalysis during screening 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 patient’s ability to complete entire duration of the study
4. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Patients with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll
5. Current smokers
6. History of cancer
7. Use of immunosuppressive medication (including but not limited to: oral corticosteroid [for reasons other than asthma], methotrexate, troleandomycin, cyclosporine, azathioprine, tacrolimus, mycofenolate mofetil, intramuscular longacting depot corticosteroid [for reasons other than asthma], or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent/assent
8. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent/assent is obtained
9. Receipt of any marketed (eg, omalizumab) or investigational biologic within 4 months or 5 half-lives prior to the date informed consent/assent is obtained, whichever is longer
10. Receipt of an influenza vaccine within 90 days prior to randomization
11. Previously received benralizumab (MEDI-563)
12. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level =2.5 times the upper limit of normal (ULN) confirmed during screening period
13. Life threatening asthma defined as episodes requiring intubation associated with
hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episodes
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method