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This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of RO5024118 following repeated inhalation in patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). Patients will be randomized to receive multiple inhaled doses of R7103, as compared with placebo. The target sample size is approximately 30 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | R7103 (dose 1) followed by placebo or placebo followed by R7103 (dose 1) |
|
| 2 | Experimental | R7103 (dose 2) followed by placebo or placebo followed by R7103 (dose 2) |
|
| 3 | Experimental | R7103 (dose 3) followed by placebo or placebo followed by R7103 (dose 3) |
|
| 4 | Experimental | R7103 (dose 4) followed by placebo or placebo followed by R7103 (dose 4) |
|
| 5 | Experimental | R7103 (dose 5) followed by placebo or placebo followed by R7103 (dose 5) |
|
| 6 | Experimental | R7103 (dose 6) followed by placebo or placebo followed by R7103 (dose 6) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R7103 | Drug | escalating inhaled dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the safety and tolerability of multiple inhaled doses of R7103 as compared to placebo, and to define the Maximum Tolerated Dose (MTD) in target population | 18 days per arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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