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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01947946
• Other study ID #: D3250C00016
• 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

• Asthma

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