Status:
TERMINATED
Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial asthma that is poorly controlled with the current standard of care.
Eligibility Criteria
Inclusion
- Adult patients with asthma \>1 year duration diagnosed according to the GINA guidelines (GINA 2010).
- Daily treatment with \> 1000μg beclomethasone dipropionate or equivalent, plus a long acting beta agonist for ≥ 3 months prior to Day 1, that has been stable for at least 4 weeks prior to screening.
- Asthma which is not adequately controlled on current treatment
- Peripheral blood eosinophil count \< 400/μl at screening
Exclusion
- Women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
- Use of other investigational drugs at the time of screening, or within 30 days of screening.
- Smokers
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01478360
Start Date
March 1 2012
End Date
November 1 2014
Last Update
November 20 2015
Active Locations (9)
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1
Novartis Investigative Site
Mainz, Germany, Germany, 55131
2
Novartis Investigative Site
Wiesbaden, Germany, Germany, 65187
3
Novartis Investigative Site
Berlin, Germany, 10117
4
Novartis Investigative Site
Frankfurt, Germany, 60596