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Safety and Efficacy of QAX576 in Adults With Moderate Persistent Allergic Asthma

This study has been withdrawn prior to enrollment.
(Due to the lack of enrolment and complexity of design, this study in asthma was terminated. No subjects have been dosed for this study.)
Information provided by (Responsible Party):
Novartis Identifier:
First received: January 9, 2008
Last updated: March 2, 2016
Last verified: March 2016
This study will evaluate the safety and efficacy of QAX576 against asthma attacks in adults with moderate persistent allergic asthma

Condition Intervention Phase
Asthma Drug: QAX576 Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Placebo Controlled, Parallel Group, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Doses of QAX576 in Moderate Persistent Allergic Asthmatics Following Inhaled Corticosteroid Withdrawal

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • - Forced expiratory volume in 1 second (FEV1)at baseline and until study completion - Levels of eosinophils in sputum [ Time Frame: Throughout the study ]

Secondary Outcome Measures:
  • - Three doses of QAX576 on time to treatment failure, plasma IL-13 levels and immunogenicity in asthmatics - Sputum biomarkers [ Time Frame: Throughout the study ]

Enrollment: 0
Study Start Date: January 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: QAX576
Placebo Comparator: 2 Drug: Placebo


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • History of asthma attacks
  • Taking inhaled corticosteroids
  • Non-smoking

Exclusion Criteria:

  • Women of child-bearing potential
  • History of respiratory disease other than asthma
  • History of severe allergy to food or drugs
  • Previous use of monoclonal antibodies
  • Very low or high body weight

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00598104

Sponsors and Collaborators
Principal Investigator: NOVARTIS Novartis investigative site
  More Information

Responsible Party: Novartis Identifier: NCT00598104     History of Changes
Other Study ID Numbers: CQAX576A2103
Study First Received: January 9, 2008
Last Updated: March 2, 2016

Keywords provided by Novartis:
Asthma, interleukin-13

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on July 21, 2017