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Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

This study has been terminated.
(Study terminated due to sponsor decision)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01947946
First received: September 11, 2013
Last updated: November 23, 2015
Last verified: October 2015
  Purpose
The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA.

Condition Intervention Phase
Asthma
Biological: Benralizumab
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to Medium-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Asthma Exacerbations Over 48 Weeks Treatment [ Time Frame: 48 weeks treatment ] [ Designated as safety issue: No ]
    The number of asthma exacerbations over 48 weeks treatment will be counted


Enrollment: 13
Study Start Date: November 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Benra 30 mg q.4 Weeks
Fixed 30 mg dose of benralizumab (every 4 weeks)
Biological: Benralizumab

Benra 30 mg q.4 Weeks is a fixed 30 mg dose of benralizumab subcutaneously on study week 0 until study week 44 inclusive.

Benra 30 mg - Placebo q.8 Weeks is a fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administrated at the 4 week interim visits to maintain blind). It is subcutaneously administered on study week 0 until study week 44 inclusive.

Experimental: Benra 30 mg - Placebo q.8 Weeks
Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
Biological: Benralizumab

Benra 30 mg q.4 Weeks is a fixed 30 mg dose of benralizumab subcutaneously on study week 0 until study week 44 inclusive.

Benra 30 mg - Placebo q.8 Weeks is a fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administrated at the 4 week interim visits to maintain blind). It is subcutaneously administered on study week 0 until study week 44 inclusive.

Placebo Comparator: Placebo
A (Dummy) injection
Biological: Placebo
Placebo subcutaneously on study week 0 until study week 44 inclusive.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion criteria:

  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 ciliary dyskinesia) 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 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. 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 patient's ability to complete entire duration of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947946

  Show 48 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: William W. Busse, MD Allergy, Pulmonary and Critical Care Medicine, Clinical Science Center 600 Highland Ave, Madison, WI USA
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01947946     History of Changes
Other Study ID Numbers: D3250C00016 
Study First Received: September 11, 2013
Results First Received: July 21, 2015
Last Updated: November 23, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
United States: Food and Drug Administration
United States: Institutional Review Board
Brazil: Ministry of Health
Mexico: Ministry of Health
Peru: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Bulgaria: Bulgarian Drug Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Turkey: Ministry of Health
Ukraine: Ministry of Health
Germany: Paul-Ehrlich-Institut
Sweden: Lakemedelsverket Medical Products Agency

Keywords provided by AstraZeneca:
Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on December 07, 2016