Status:
COMPLETED
Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
Lead Sponsor:
Novartis
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.
Eligibility Criteria
Inclusion
- Male and female patients 18 to 65 years old (inclusive)
- Patients with mild to moderate persistent asthma
- BMI must be within the range of 18-32 kg/m2 inclusive
- Female subjects must:
- have been sterilized at least 6 months prior to screening
- be post-menopausal with no regular bleeding for at least a year prior to inclusion
Exclusion
- Patients with life-threatening arrhythmias
- Patients with COPD or diabetes mellitus
- History of immunocompromise, including a positive HIV
- A positive Hepatitis B surface antigen (HBsAg) of Hepatitis C test result
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00624702
Start Date
February 1 2008
End Date
September 1 2008
Last Update
December 19 2020
Active Locations (2)
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1
Novartis Investigator Site
Ottawa, Ontario, Canada
2
Novartis Investigator Site
Montreal, Quebec, Canada