Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
NCT ID: NCT00624702
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
98 participants
INTERVENTIONAL
2008-02-29
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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1
Active Comparator 1 different salt formulation of Indacaterol.
Indacaterol maleate
Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
2
Active Comparator 2 different salt formulation of Indacaterol.
Indacaterol maleate
Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
3
Active Comparator 3 different salt formulation of Indacaterol.
Indacaterol maleate
Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
4
Placebo
Interventions
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Indacaterol maleate
Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
Indacaterol maleate
Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
Indacaterol maleate
Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
Placebo
Eligibility Criteria
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Inclusion Criteria
* Patients with mild to moderate persistent asthma
* BMI must be within the range of 18-32 kg/m2 inclusive
* Female subjects must:
1. have been sterilized at least 6 months prior to screening
2. be post-menopausal with no regular bleeding for at least a year prior to inclusion
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis
Role: PRINCIPAL_INVESTIGATOR
Novartis investigator site
Locations
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Novartis Investigator Site
Ottawa, Ontario, Canada
Novartis Investigator Site
Montreal, Quebec, Canada
Countries
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Related Links
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Results for QAB149B2102 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CQAB149B2102
Identifier Type: -
Identifier Source: org_study_id