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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006770-14 | EudraCT Number |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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Objectives of the study are to investigate the safety, tolerability and levels of ciprofloxacin in the lung after single and multiple inhalative administration to patients with mild to moderate COPD (stage I-II according to GOLD Criteria).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
| |
| Arm 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin (Cipro inhale, BAYQ3939) | Drug | 32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d. |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs: evaluated by heart rate, blood pressure, clinical laboratory | Within 28 days after first treatment | |
| Electrocardiogram: evaluated by shape and time intervals | Within 28 days after first treatment | |
| Pulmonary function test evaluated by FEV1 | Within 28 days after first treatment | |
| Pulse oximetry by peripheral oxygen concentration | Within 12 days after first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of ciprofloxacin concentration in blood | Within 14 days after first treatment | |
| Determination of ciprofloxacin concentration in urine | Within 14 days after first treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mannheim | Baden-Wurttemberg | 68167 | Germany |
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| Ciprofloxacin (Cipro inhale, BAYQ3939) | Drug | 32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given three times daily (tid) with a concluding single dose on 11d. |
|
| Ciprofloxacin (Cipro inhale, BAYQ3939) | Drug | 48.75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d. |
|
| Placebo | Drug | Placebo inhalation powder will be given as an initial single dose inhalation on 00d.During the multiple dose phase placebo will be given twice/three-times daily with a concluding single dose on day 11d. |
|
| Determination of ciprofloxacin concentration in sputum |
| Within 14 days after first treatment |
| Determination of ciprofloxacin concentration in oral rinsing fluid | Within 7 days after first treatment |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D053120 | Respiratory Aspiration |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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