Efficacy of QAX576 in Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01130064
First received: May 24, 2010
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment with QAX576 in patients with persistent asthma not adequately controlled with inhaled corticosteroids and long acting beta2-agonists.


Condition Intervention Phase
Asthma
Biological: QAX576
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double Blind, Placebo-controlled, 'add-on' Study to Investigate the Efficacy and Safety of 24 Weeks Intravenous Treatment With QAX576 in Patients (≥18-75 Years) With Persistent Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting β2-agonists

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Asthma Control Questionnaire [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence rate of clinically significant asthma exacerbations [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 259
Study Start Date: May 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QAX576
QAX576
Biological: QAX576
every 3 weeks via intravenous infusion
Placebo Comparator: Placebo
Placebo
Drug: Placebo
every 3 weeks via intravenous infusion

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients
  • Female patients must be surgically sterilized or postmenopausal
  • Male patients must use two forms of contraception
  • Body mass index must be between 18 and 39 kg/m2
  • Diagnosis of asthma for at least one year, which is not adequately controlled by inhaled corticosteroids and long acting beta-2 agonists

Exclusion Criteria:

  • Smoking history >10 pack-years
  • Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
  • Patients who have experienced a severe asthma attack/exacerbation requiring systemic corticosteroids or an increase in maintenance doses, within 6 weeks of screening
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening
  • History of schistosomiasis, within 6 months of screening, or traveling to a country endemic with schistosomiasis within 6 months of completing 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: NCT01130064

  Hide Study Locations
Locations
United States, Arizona
Novartis Investigative Site
Phoenix, Arizona, United States, 85006
United States, California
Novartis Investigative Site
Huntington Beach, California, United States, 92647
United States, Kentucky
Novartis Investigative Site
Owensboro, Kentucky, United States, 42301
United States, Maryland
Novartis Investigative Site
Wheaton, Maryland, United States, 20902
United States, Minnesota
Novartis Investigative Site
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Novartis Investigative Site
St. Louis, Missouri, United States, 63141
United States, Nevada
Novartis Investigative Site
Las Vegas, Nevada, United States, 89119
United States, Ohio
Novartis Investigative Site
Marion, Ohio, United States, 43302
United States, South Carolina
Novartis Investigative Site
Charleston, South Carolina, United States, 29407
Novartis Investigative Site
Summerville, South Carolina, United States, 29485
Argentina
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000DSV
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000DBS
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000JKR
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000CXH
Novartis Investigative Site
Buenos Aires, Argentina, C1122AAK
Novartis Investigative Site
Buenos Aires, Argentina, B8000XAV
Novartis Investigative Site
Buenos Aires, Argentina, C1186ACB
Novartis Investigative Site
Buenos Aires, Argentina, C1125ABE
Novartis Investigative Site
Mendoza, Argentina, M5500FIK
Novartis Investigative Site
Santa Fe, Argentina, S3000FIL
Belgium
Novartis Investigative Site
Bruxelles, Belgium, 1070
Novartis Investigative Site
Eupen, Belgium, 4700
Novartis Investigative Site
Gent, Belgium, 9000
Novartis Investigative Site
Laeken, Belgium, 1020
Novartis Investigative Site
Leuven, Belgium, 3000
Novartis Investigative Site
Liège, Belgium, 4000
Czech Republic
Novartis Investigative Site
Teplice, CZE, Czech Republic, 415 01
Novartis Investigative Site
Rokycany, Czech Republic, 337 01
Novartis Investigative Site
Strakonice, Czech Republic, 38601
Novartis Investigative Site
Tabor, Czech Republic, 390 01
Germany
Novartis Investigative Site
Berlin, Germany, 14050
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Frankfurt, Germany, 60596
Novartis Investigative Site
Grosshansdorf, Germany, 22947
Novartis Investigative Site
Kassel, Germany, 34121
Novartis Investigative Site
Leipzig, Germany, 04357
Novartis Investigative Site
Leipzig, Germany, 04207
Novartis Investigative Site
Mainz, Germany, D-55101
Novartis Investigative Site
Rüdersdorf, Germany, 15562
Poland
Novartis Investigative Site
Bialystok, Poland, 15-010
Novartis Investigative Site
Gdansk, Poland, 80-211
Novartis Investigative Site
Lodz, Poland, 90-153
Novartis Investigative Site
Lublin, Poland, 20-89
Novartis Investigative Site
Poznan, Poland, 60-569
Russian Federation
Novartis Investigative Site
Kazan, Tatarstan Republic, Russian Federation, 420015
Novartis Investigative Site
Barnaul, Russian Federation, 656045
Novartis Investigative Site
Moscow, Russian Federation, 105077
Novartis Investigative Site
Moscow, Russian Federation, 115280
Novartis Investigative Site
Nizhny Novgorod, Russian Federation, 603018
Novartis Investigative Site
Ryazan, Russian Federation, 390026
Novartis Investigative Site
Samara, Russian Federation, 443079
Novartis Investigative Site
Yaroslavl, Russian Federation, 150003
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01130064     History of Changes
Other Study ID Numbers: CQAX576A2207, 2009-011590-32
Study First Received: May 24, 2010
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: The Bavarian State Ministry of the Environment and Public Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation

Keywords provided by Novartis:
Asthma
QAX576

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 August 01, 2014