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

This study is not yet open for participant recruitment.

Verified by Novartis, July 2008

First Received: January 9, 2008 Last Updated: July 14, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00598104

Purpose

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 I Phase II

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	60
Study Start Date:	January 2008
Estimated Study Completion Date:	November 2008

Arms	Assigned Interventions
1: Experimental	Drug: QAX576
2: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598104

Contacts

Contact: Novartis

862 778 8300

Locations

United States, Nebraska
Novartis Investigative Site
Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

NOVARTIS

Novartis investigative site

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CQAX576A2103
Study First Received:	January 9, 2008
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00598104 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Asthma, interleukin-13

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009