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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00624702 |
This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Indacaterol maleate Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study |
Official Title: | A Multi-Center, Randomized, Single-Dose, Double-Blind, 4-Way Cross-Over Study to Evaluate Tolerability Following Treatment With Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma |
Estimated Enrollment: | 100 |
Study Start Date: | February 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Active Comparator 1 different salt formulation of Indacaterol.
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Drug: 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
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2: Active Comparator
Active Comparator 2 different salt formulation of Indacaterol.
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Drug: 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
Active Comparator 3 different salt formulation of Indacaterol.
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Drug: 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
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4: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Female subjects must:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Canada, Ontario | |
Novartis Investigator Site | |
Ottawa, Ontario, Canada | |
Canada, Quebec | |
Novartis Investigator Site | |
Montreal, Quebec, Canada |
Principal Investigator: | Novartis | Novartis investigator site |
Responsible Party: | Novartis ( Novartis ) |
Study ID Numbers: | CQAB149B2102 |
Study First Received: | February 15, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00624702 |
Health Authority: | Canada: Health Canada |
Asthma, cough, spirometry, maleate, xinafoate, acetate, SDDPI (single dose dry powder inhaler) |
Asthma Cough Naphazoline Oxymetazoline Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases |
Maleic acid Phenylephrine Guaifenesin Lung Diseases Hypersensitivity, Immediate Phenylpropanolamine Respiratory Hypersensitivity |
Molecular Mechanisms of Pharmacological Action Immune System Diseases Bronchial Diseases Enzyme Inhibitors Pharmacologic Actions |