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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: February 20, 2017
Last verified: February 2017
  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: Quadruple (Participant, Care Provider, 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

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Asthma Control Questionnaire [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Incidence rate of clinically significant asthma exacerbations [ Time Frame: 24 weeks ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Show 52 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01130064     History of Changes
Other Study ID Numbers: CQAX576A2207
2009-011590-32 ( EudraCT Number )
Study First Received: May 24, 2010
Last Updated: February 20, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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 18, 2017