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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01947946
Other study ID # D3250C00016
Secondary ID
Status Terminated
Phase Phase 3
First received September 11, 2013
Last updated November 23, 2015
Start date November 2013
Est. completion date July 2014

Study information

Verified date October 2015
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaUnited States: Food and Drug AdministrationUnited States: Institutional Review BoardBrazil: Ministry of HealthMexico: Ministry of HealthPeru: Ministry of HealthJapan: Ministry of Health, Labor and WelfareBulgaria: Bulgarian Drug AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSouth Africa: Medicines Control CouncilTurkey: Ministry of HealthUkraine: Ministry of HealthGermany: Paul-Ehrlich-InstitutSweden: Lakemedelsverket Medical Products Agency
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 13
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
Placebo subcutaneously on study week 0 until study week 44 inclusive.

Locations

Country Name City State
Argentina Research Site Buenos Aires
Argentina Research Site Ciudad de Buenos Aire
Brazil Research Site São Paulo
Bulgaria Research Site Ruse
Bulgaria Research Site Sofia
Bulgaria Research Site Varna
Germany Research Site Hamburg
Germany Research Site Mainz
Poland Research Site Bydgoszcz
Poland Research Site Gizycko
Poland Research Site Lódz
Poland Research Site Lubin
Poland Research Site Ostrów Wielkopolski
Poland Research Site Warszawa
Poland Research Site Wroclaw
Poland Research Site Znin
Russian Federation Research Site Chelyabinsk
Russian Federation Research Site Ekaterinburg
Russian Federation Research Site Izhevsk
Russian Federation Research Site Kazan
Russian Federation Research Site Moscow
Russian Federation Research Site Novosibirsk
Russian Federation Research Site Pyatigorsk
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site St. Petersburg
Russian Federation Research Site Ulyanovsk
Russian Federation Research Site Vladikavkaz
United States Research Site Arlington Texas
United States Research Site Austin Texas
United States Research Site Bellevue Nebraska
United States Research Site Birmingham Alabama
United States Research Site Centennial Colorado
United States Research Site Dallas Texas
United States Research Site Glendale Arizona
United States Research Site Las Vegas Nevada
United States Research Site Lawrenceville Georgia
United States Research Site Miami Florida
United States Research Site Oklahoma City Oklahoma
United States Research Site Orlando Florida
United States Research Site Pembroke Pines Florida
United States Research Site Pittsburgh Pennsylvania
United States Research Site Rock Hill South Carolina
United States Research Site San Antonio Texas
United States Research Site San Jose California
United States Research Site Savannah Georgia
United States Research Site Sugarland Texas
United States Research Site Warwick Rhode Island
United States Research Site Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Germany,  Poland,  Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Asthma Exacerbations Over 48 Weeks Treatment The number of asthma exacerbations over 48 weeks treatment will be counted 48 weeks treatment No
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