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This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indacaterol 150 µg | Experimental | Indacaterol 150 µg |
|
| Indacaterol 300 µg | Experimental | Indacaterol 300 µg |
|
| Indacaterol 600 µg | Experimental | Indacaterol 600 µg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Placebo/moxifloxacin | Active Comparator | Placebo/moxifloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol 150 µg | Drug | Once daily (QD) via single-dose dry powder inhaler (SDDPI) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QTc interval (Fridericia's) | Change from baseline (prior to the first dose) to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in uncorrected QT interval | Change from baseline (prior to the first dose) to Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis investigative site | Miami | Florida | 33126 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21615886 | Derived | Khindri S, Sabo R, Harris S, Woessner R, Jennings S, Drollmann AF. Cardiac safety of indacaterol in healthy subjects: a randomized, multidose, placebo- and positive-controlled, parallel-group thorough QT study. BMC Pulm Med. 2011 May 26;11:31. doi: 10.1186/1471-2466-11-31. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C510790 | indacaterol |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Indacaterol 300 µg |
| Drug |
QD via SDDPI |
|
| Indacaterol 600 µg | Drug | QD via SDDPI |
|
| Placebo | Drug | QD via SDDPI |
|
| Placebo/moxifloxacin | Drug | Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |