Efficacy and safety study of benralizumab added to high-dose inhaled corticosteroid plus LABA in patients with uncontrolled asthma
- Conditions
- AsthmaMedDRA version: 17.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-002345-11-PL
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1134
1. Written informed consent for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent[s]/guardian[s]) and according to international guidelines and/or applicable European Union guidelines.
2. Female and Male aged 12 to 75 years inclusively, at the time of visit 1. For those patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial.
3. History of physician diagnosed asthma requiring treatment with medium to high dose inhaled corticosteroids (greater than 250 microgrammes fluticasone dry powder formulation equivalents total daily dose) and a LABA for at least 12 months prior to visit 1
4. Documented treatment with ICS and LABA for at least 3 month prior to Visit 1 with or without oral corticosteroids and additional asthma controllers.
For subjects 18 years of age and older, the ICS dose must be greater than 500 mcg/day fluticasone propionate dry powder formulation or equivalent daily.
-For subjects ages 12-17, the ICS dose must be greater than or equal to 500 mcg /day fluticasone propionate dry powder formulation or equivalent daily
Are the trial subjects under 18? yes
Number of subjects for this age range: 75
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1002
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 57
1. 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, alpha 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, hypereosinophilic syndrome)
2. 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 study or their interpretations, or impede the patients ability to complete the entire duration of study.
3. 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.
4. 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
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of this study is to evaluate the effect of two dosing regimens of benralizumab on asthma exacerbations in patients on high-dose ICS-LABA with uncontrolled asthma;Secondary Objective: To assess the effect of two dosing regimens of benralizumab on: <br>Pulmonary function <br>Asthma symptoms and other asthma control metrics <br>Other parameters associated with asthma exacerbations<br>Emergency room visits and hospitalisations due to asthma <br>Pharmacokinetics and immunogenicity <br>Safety and tolerability<br>Asthma related and general health-related quality of life<br>Health care resource utilization and productivity loss due to asthma <br>;Primary end point(s): Annual asthma exacerbation rate;Timepoint(s) of evaluation of this end point: 48 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Pre bronchodilator FEV1 and post-bronchodilator FEV1 at the study centre <br>2. Asthma symptom score (total, daytime and night time), rescue medication use, home lung function (morning and evening PEF), nights with awakening due to asthma, ACQ-6, AQLQ(S)+12, EQ-5D-5L<br>3. Annual rate of exacerbations associated with an emergency room/urgent care visit or hospitalisation <br>4.Time to first asthma exacerbation and proportion of patients with =1 asthma exacerbation<br>5.WPAI+CIQ and Asthma specific resource utilization<br>6. PK parameters and anti-drug antibodies <br>7. AE/SAE, laboratory variables, ECG, physical examination;Timepoint(s) of evaluation of this end point: 48 weeks