Status:
COMPLETED
A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims t...
Eligibility Criteria
Inclusion
- Male and female patients with asthma
- Aged 18 or above
- Patients using inhaled corticosteroid (with or without long acting beta agonist)
- Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist
Exclusion
- Asthma exacerbations in previous 6 months
- COPD or other pulmonary disease
- Excessive use of short acting beta agonists
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01484197
Start Date
November 1 2011
End Date
May 1 2012
Last Update
April 1 2015
Active Locations (2)
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1
Novartis Investigative Site
Wiesbaden, Germany, Germany, 65187
2
Novartis Investigative Site
Machester, United Kingdom, M23 9QZ