Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma

Study Overview
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Brief Summary
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This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Indacaterol maleate
* Drug: Indacaterol maleate
* Drug: Indacaterol maleate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Active Comparator 1 different salt formulation of Indacaterol. | Drug: Indacaterol maleate<br>* Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval<br>|
| Active Comparator: 2<br>Active Comparator 2 different salt formulation of Indacaterol. | Drug: Indacaterol maleate<br>* Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval<br>|
| Active Comparator: 3<br>Active Comparator 3 different salt formulation of Indacaterol. | Drug: Indacaterol maleate<br>* Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation) |  | throughout the study | 
| Severity of cough: to be judged independently by both the patient and the physician |  | throughout the study | 
| Occurrence of cough within 1 minute post dose |  | throughout the study | 
| Number of coughs |  | throughout the study | 
| Duration of coughing |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation) |  | throughout the study | 
| Severity of cough: to be judged independently by both the patient and the physician |  | throughout the study | 
| Occurrence of cough within 1 minute post dose |  | throughout the study | 
| Number of coughs |  | throughout the study | 
| Duration of coughing |  | throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, cough, spirometry, maleate, xinafoate, acetate, SDDPI (single dose dry powder inhaler)