- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00598104
Safety and Efficacy of QAX576 in Adults With Moderate Persistent Allergic Asthma
March 2, 2016 updated by: Novartis
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
This study will evaluate the safety and efficacy of QAX576 against asthma attacks in adults with moderate persistent allergic asthma
Study Overview
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
|
Placebo Comparator: 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- Forced expiratory volume in 1 second (FEV1)at baseline and until study completion - Levels of eosinophils in sputum
Time Frame: Throughout the study
|
Throughout the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- Three doses of QAX576 on time to treatment failure, plasma IL-13 levels and immunogenicity in asthmatics - Sputum biomarkers
Time Frame: Throughout the study
|
Throughout the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
January 9, 2008
First Submitted That Met QC Criteria
January 9, 2008
First Posted (Estimate)
January 18, 2008
Study Record Updates
Last Update Posted (Estimate)
March 4, 2016
Last Update Submitted That Met QC Criteria
March 2, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CQAX576A2103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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