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

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ClinicalTrials.gov Identifier: NCT00598104
Recruitment Status : Withdrawn (Due to the lack of enrolment and complexity of design, this study in asthma was terminated. No subjects have been dosed for this study.)
First Posted : January 18, 2008
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will evaluate the safety and efficacy of QAX576 against asthma attacks in adults with moderate persistent allergic asthma

Condition or disease Intervention/treatment Phase
Asthma Drug: QAX576 Drug: Placebo Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : January 2008
Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: QAX576
Placebo Comparator: 2 Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. - 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 :
  1. - Three doses of QAX576 on time to treatment failure, plasma IL-13 levels and immunogenicity in asthmatics - Sputum biomarkers [ Time Frame: Throughout the study ]

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598104


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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00598104     History of Changes
Other Study ID Numbers: CQAX576A2103
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016

Keywords provided by Novartis:
Asthma, interleukin-13

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases