Status:
COMPLETED
A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.
Eligibility Criteria
Inclusion
- Patients with atopic asthma \>1 year duration diagnosed according to the GINA guidelines.
- Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 39 kg/m2.
- Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of \> 1.5.
- FEV1 40 to 90% of predicted.
Exclusion
- Diagnosed with COPD as defined by the GOLD guidelines
- Subjects who have had a respiratory tract infection within 4 weeks prior to screening.
- Women of child-bearing potential must use highly effective methods of contraception during dosing and for at least 18 weeks after last study drug administration
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01479595
Start Date
February 1 2012
End Date
February 1 2015
Last Update
August 1 2016
Active Locations (20)
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1
Novartis Investigative Site
Anaheim, California, United States, 92801
2
Novartis Investigative Site
Riverside, California, United States, 92506
3
Novartis Investigative Site
Rolling Hills Estates, California, United States, 90274
4
Novartis Investigative Site
San Marino, California, United States, 91108