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OpenTrials
Completed

NCT Number: NCT01130064

Efficacy of QAX576 in Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QAX576

Biological

every 3 weeks via intravenous infusion

Placebo

Drug

every 3 weeks via intravenous infusion

Primary outcomes

  1. Asthma Control Questionnaire

    Time frame: 24 weeks

Secondary outcomes

  1. Incidence rate of clinically significant asthma exacerbations

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 25, 2010
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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