Efficacy of QAX576 in Asthma
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
2 other identifiers
interventional
259
7 countries
52
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started May 2010
Typical duration for phase_2 asthma
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 24, 2010
CompletedFirst Posted
Study publicly available on registry
May 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedDecember 19, 2020
February 1, 2017
1.9 years
May 24, 2010
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Asthma Control Questionnaire
24 weeks
Secondary Outcomes (1)
Incidence rate of clinically significant asthma exacerbations
24 weeks
Study Arms (2)
QAX576
EXPERIMENTALQAX576
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Novartis Investigative Site
Phoenix, Arizona, 85006, United States
Novartis Investigative Site
Huntington Beach, California, 92647, United States
Novartis Investigative Site
Owensboro, Kentucky, 42301, United States
Novartis Investigative Site
Wheaton, Maryland, 20902, United States
Novartis Investigative Site
Minneapolis, Minnesota, 55402, United States
Novartis Investigative Site
St Louis, Missouri, 63141, United States
Novartis Investigative Site
Las Vegas, Nevada, 89119, United States
Novartis Investigative Site
Marion, Ohio, 43302, United States
Novartis Investigative Site
Charleston, South Carolina, 29407, United States
Novartis Investigative Site
Summerville, South Carolina, 29485, United States
Novartis Investigative Site
CABA, Buenos Aires, B8000XAV, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1122AAK, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1186ACB, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2000CXH, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DBS, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DSV, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2000JKR, Argentina
Novartis Investigative Site
Buenos Aires, C1125ABE, Argentina
Novartis Investigative Site
Mendoza, M5500FIK, Argentina
Novartis Investigative Site
Santa Fe, S3000FIL, Argentina
Novartis Investigative Site
Brussels, 1070, Belgium
Novartis Investigative Site
Eupen, 4700, Belgium
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Laken, 1020, Belgium
Novartis Investigative Site
Leuven, 3000, Belgium
Novartis Investigative Site
Liège, 4000, Belgium
Novartis Investigative Site
Rokycany, Czech Republic, 337 01, Czechia
Novartis Investigative Site
Strakonice, Czech Republic, 38601, Czechia
Novartis Investigative Site
Teplice, CZE, 415 01, Czechia
Novartis Investigative Site
Tábor, 390 01, Czechia
Novartis Investigative Site
Berlin, 10117, Germany
Novartis Investigative Site
Berlin, 14050, Germany
Novartis Investigative Site
Frankfurt, 60596, Germany
Novartis Investigative Site
Großhansdorf, 22947, Germany
Novartis Investigative Site
Kassel, 34121, Germany
Novartis Investigative Site
Leipzig, 04207, Germany
Novartis Investigative Site
Leipzig, 04357, Germany
Novartis Investigative Site
Mainz, 55131, Germany
Novartis Investigative Site
Rüdersdorf, 15562, Germany
Novartis Investigative Site
Bialystok, 15-010, Poland
Novartis Investigative Site
Gdansk, 80-211, Poland
Novartis Investigative Site
Lodz, 90-153, Poland
Novartis Investigative Site
Lublin, 20-89, Poland
Novartis Investigative Site
Poznan, 60-569, Poland
Novartis Investigative Site
Kazan', Tatarstan Republic, 420015, Russia
Novartis Investigative Site
Barnaul, 656045, Russia
Novartis Investigative Site
Moscow, 105077, Russia
Novartis Investigative Site
Moscow, 115280, Russia
Novartis Investigative Site
Nizhny Novgorod, 603018, Russia
Novartis Investigative Site
Ryazan, 390026, Russia
Novartis Investigative Site
Samara, 443079, Russia
Novartis Investigative Site
Yaroslavl, 150003, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2010
First Posted
May 25, 2010
Study Start
May 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
December 19, 2020
Record last verified: 2017-02