Efficacy of QAX576 in Asthma

NCT ID: NCT01130064

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma QAX576

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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QAX576

QAX576

Group Type EXPERIMENTAL

QAX576

Intervention Type BIOLOGICAL

every 3 weeks via intravenous infusion

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

every 3 weeks via intravenous infusion

Interventions

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QAX576

every 3 weeks via intravenous infusion

Intervention Type BIOLOGICAL

Placebo

every 3 weeks via intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Phoenix, Arizona, United States

Site Status

Novartis Investigative Site

Huntington Beach, California, United States

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Owensboro, Kentucky, United States

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Wheaton, Maryland, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Marion, Ohio, United States

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Charleston, South Carolina, United States

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Summerville, South Carolina, United States

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CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Mendoza, , Argentina

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Santa Fe, , Argentina

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Brussels, , Belgium

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Eupen, , Belgium

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Ghent, , Belgium

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Laken, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Rokycany, Czech Republic, Czechia

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Strakonice, Czech Republic, Czechia

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Teplice, CZE, Czechia

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Tábor, , Czechia

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Berlin, , Germany

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Berlin, , Germany

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Frankfurt, , Germany

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Großhansdorf, , Germany

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Kassel, , Germany

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Leipzig, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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Rüdersdorf, , Germany

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Bialystok, , Poland

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Gdansk, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Kazan', Tatarstan Republic, Russia

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Barnaul, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Ryazan, , Russia

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Samara, , Russia

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Novartis Investigative Site

Yaroslavl, , Russia

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Countries

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United States Argentina Belgium Czechia Germany Poland Russia

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=8063

Results for CQAX576A2207 from Novartis Clinical Trials website

Other Identifiers

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2009-011590-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQAX576A2207

Identifier Type: -

Identifier Source: org_study_id