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This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Active Comparator 1 different salt formulation of Indacaterol. |
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| 2 | Active Comparator | Active Comparator 2 different salt formulation of Indacaterol. |
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| 3 | Active Comparator | Active Comparator 3 different salt formulation of Indacaterol. |
|
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol maleate | Drug | Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval |
|
| 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 |
| 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 |
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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:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Ottawa | Ontario | Canada | |||
| Novartis Investigator Site |
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| Label | URL |
|---|---|
| Results for QAB149B2102 can be found on the Novartis Clinical Trial Results Website | View source |
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| Indacaterol maleate | Drug | 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 | Drug | 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 | Drug |
|
| Occurrence of cough within 1 minute post dose | throughout the study |
| Number of coughs | throughout the study |
| Duration of coughing | throughout the study |
| Montreal |
| Quebec |
| Canada |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D003371 | Cough |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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