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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00598104
• Other study ID #: CQAX576A2103
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: January 9, 2008
• Last updated: March 2, 2016
• Start date: January 2008

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of QAX576 against asthma attacks in adults with moderate persistent allergic asthma

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• QAX576

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Forced expiratory volume in 1 second (FEV1)at baseline and until study completion - Levels of eosinophils in sputum		Throughout the study	No
Secondary	- Three doses of QAX576 on time to treatment failure, plasma IL-13 levels and immunogenicity in asthmatics - Sputum biomarkers		Throughout the study	No