NCT00598104

Brief Summary

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

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

January 9, 2008

Last Update Submit

March 2, 2016

Conditions

Asthma

Keywords

Asthma, interleukin-13

Outcome Measures

Primary Outcomes (1)

  • - Forced expiratory volume in 1 second (FEV1)at baseline and until study completion - Levels of eosinophils in sputum

    Throughout the study

Secondary Outcomes (1)

  • - Three doses of QAX576 on time to treatment failure, plasma IL-13 levels and immunogenicity in asthmatics - Sputum biomarkers

    Throughout the study

Study Arms (2)

1

EXPERIMENTAL
Drug: QAX576

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

QAX576DRUG
1
PlaceboDRUG
2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AsthmaRhinitis, Allergic

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic Diseases

Study Officials

  • NOVARTIS

    Novartis investigative site

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 18, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Last Updated

March 4, 2016

Record last verified: 2016-03