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The purpose of this study is to determine the safety and tolerability of single doses of QAB149 up to 3000 µg delivered via a single-dose, dry powder inhaler in patients with mild to moderate COPD.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QAB149 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (laboratory tests, ECG, adverse events) |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function tests | ||
| Pharmacokinetics |
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Inclusion Criteria:
Male and/or female patients with mild to moderate stable COPD, diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines; 40-75 years of age
Prebronchodilator baseline forced expiratory volume in 1 second (FEV1) 30-80% of the Quanjer predicted normal value (Quanjer et al. 1993) and at least 0.75 L with FEV1/forced vital capacity (FVC) < 70% of predicted [GOLD guidelines].
Previous smokers (>10 pack-years). Ten pack years are defined as: 20 cigarettes a day for 10 years; 10 cigarettes a day for 20 years; or 40 cigarettes a day for 5 years. Current smokers, with >10 pack year history, can be included under certain conditions.
Vital signs (after 3 minutes resting measured in the supine position) which are within the following ranges:
Patients must weigh a minimum of 50 kg to participate in this study.
Able to provide written informed consent prior to study participation.
Able to communicate well with the investigator and comply with the requirements of the study.
Exclusion Criteria:
Other exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Encinitas | California | 92024 | United States | ||
| Radiant Research |
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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 |
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| Boise |
| Idaho |
| 83704 |
| United States |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |