Efficacy of QAX576 in Asthma

December 11, 2020 updated by: Novartis Pharmaceuticals

A Multi-center, Randomized, Double Blind, Placebo-controlled, 'add-on' Study to Investigate the Efficacy and Safety of 24 Weeks Intravenous Treatment With QAX576 in Patients (≥18-75 Years) With Persistent Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting β2-agonists

The purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment with QAX576 in patients with persistent asthma not adequately controlled with inhaled corticosteroids and long acting beta2-agonists.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

259

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1125ABE
        • Novartis Investigative Site
      • Mendoza, Argentina, M5500FIK
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000FIL
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1122AAK
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, B8000XAV
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1186ACB
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CXH
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S2000DBS
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S2000DSV
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S2000JKR
        • Novartis Investigative Site
  • Belgium
      • Bruxelles, Belgium, 1070
        • Novartis Investigative Site
      • Eupen, Belgium, 4700
        • Novartis Investigative Site
      • Gent, Belgium, 9000
        • Novartis Investigative Site
      • Laeken, Belgium, 1020
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
      • Liège, Belgium, 4000
        • Novartis Investigative Site
  • Czechia
      • Tabor, Czechia, 390 01
        • Novartis Investigative Site
    • CZE
      • Teplice, CZE, Czechia, 415 01
        • Novartis Investigative Site
    • Czech Republic
      • Rokycany, Czech Republic, Czechia, 337 01
        • Novartis Investigative Site
      • Strakonice, Czech Republic, Czechia, 38601
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10117
        • Novartis Investigative Site
      • Berlin, Germany, 14050
        • Novartis Investigative Site
      • Frankfurt, Germany, 60596
        • Novartis Investigative Site
      • Grosshansdorf, Germany, 22947
        • Novartis Investigative Site
      • Kassel, Germany, 34121
        • Novartis Investigative Site
      • Leipzig, Germany, 04207
        • Novartis Investigative Site
      • Leipzig, Germany, 04357
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • Rüdersdorf, Germany, 15562
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15-010
        • Novartis Investigative Site
      • Gdansk, Poland, 80-211
        • Novartis Investigative Site
      • Lodz, Poland, 90-153
        • Novartis Investigative Site
      • Lublin, Poland, 20-89
        • Novartis Investigative Site
      • Poznan, Poland, 60-569
        • Novartis Investigative Site
  • Russian Federation
      • Barnaul, Russian Federation, 656045
        • Novartis Investigative Site
      • Moscow, Russian Federation, 115280
        • Novartis Investigative Site
      • Moscow, Russian Federation, 105077
        • Novartis Investigative Site
      • Nizhny Novgorod, Russian Federation, 603018
        • Novartis Investigative Site
      • Ryazan, Russian Federation, 390026
        • Novartis Investigative Site
      • Samara, Russian Federation, 443079
        • Novartis Investigative Site
      • Yaroslavl, Russian Federation, 150003
        • Novartis Investigative Site
    • Tatarstan Republic
      • Kazan, Tatarstan Republic, Russian Federation, 420015
        • Novartis Investigative Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Novartis Investigative Site
    • California
      • Huntington Beach, California, United States, 92647
        • Novartis Investigative Site
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Novartis Investigative Site
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Novartis Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Novartis Investigative Site
    • Ohio
      • Marion, Ohio, United States, 43302
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Novartis Investigative Site
      • Summerville, South Carolina, United States, 29485
        • Novartis Investigative Site

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients
  • Female patients must be surgically sterilized or postmenopausal
  • Male patients must use two forms of contraception
  • Body mass index must be between 18 and 39 kg/m2
  • Diagnosis of asthma for at least one year, which is not adequately controlled by inhaled corticosteroids and long acting beta-2 agonists

Exclusion Criteria:

  • Smoking history >10 pack-years
  • Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
  • Patients who have experienced a severe asthma attack/exacerbation requiring systemic corticosteroids or an increase in maintenance doses, within 6 weeks of screening
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening
  • History of schistosomiasis, within 6 months of screening, or traveling to a country endemic with schistosomiasis within 6 months of completing the study

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
every 3 weeks via intravenous infusion
Experimental: QAX576
Biological: QAX576
every 3 weeks via intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Asthma Control Questionnaire
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of clinically significant asthma exacerbations
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

May 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

May 24, 2010

First Posted (Estimate)

May 25, 2010

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAX576A2207
  • 2009-011590-32 (EudraCT Number)

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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