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This study will evaluate the pharmacokinetics, pharmacodynamics and safety of multiple doses of the NVA237 in mild and moderate COPD patients .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | NVA237 |
|
| 2 | Experimental | NVA237 |
|
| 3 | Experimental | NVA237 |
|
| 4 | Experimental | NVA237 |
|
| 5 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVA237 | Drug |
| ||
| NVA237 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of NVA237 following single and repeated once-daily inhaled NVA237 doses |
| Measure | Description | Time Frame |
|---|---|---|
| -Pharmacodynamics (PD) and PK/PD relationships of NVA237 following single and repeated once-daily inhaled NVA237 doses -Safety and tolerability of NVA237 following single and repeated once-daily inhaled NVA237 doses |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative site | Copenhagen | Denmark | ||||
| Novartis investigative site |
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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 |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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| NVA237 | Drug |
|
| NVA237 | Drug |
|
| Placebo | Drug |
|
| Berlin |
| Germany |
| Novartis investigative site | Mönchengladbach | Germany |
| Novartis Investigative Site | Munich | Germany |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011759 |
| Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |