Efficacy of QAX576 in Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Biological: 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

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-05-24
• Study First Posted: 2010-05-25
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2017-02
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-28
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-19

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