Efficacy of QAX576 in Asthma
Phase 2
Completed
- Conditions
- Asthma
- Interventions
- Drug: PlaceboBiological: QAX576
- Registration Number
- NCT01130064
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 259
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo QAX576 QAX576 QAX576
- Primary Outcome Measures
Name Time Method Asthma Control Questionnaire 24 weeks
- Secondary Outcome Measures
Name Time Method Incidence rate of clinically significant asthma exacerbations 24 weeks
Trial Locations
- Locations (1)
Novartis Investigative Site
🇷🇺Yaroslavl, Russian Federation