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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018521-19 | EudraCT Number |
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The purpose of this study is to compare the safety and pharmacokinetics of ciprofloxacin after inhalation of single 52.5 and 48.75 mg doses in COPD patients. In this study the 48.75 mg dose will be administered for the first time using a new high dose strength (i.e. one capsule containing 75 mg powder = 48.75 mg ciprofloxacin) formulation. Safety investigations will focus on local tolerability in the lung and evaluate whether the patient can inhale the higher amount of powder compared to the lower dose strength. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this study will be used to decide whether the new dose strength is suitable for larger clinical trials planned for the COPD patients population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cipro Inhale (Ciprofloxacin, BAYQ3939) | Drug | 32.5 mg ciprofloxacin corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of ciprofloxacin pharmacokinetics derived from drug concentrations in blood, urine and sputum | Within 24 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events collection | Within 30 days |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with a significant respiratory disease other than COPD.
Exacerbation within 8 weeks prior to screening
Subjects with more than 1 COPD exacerbation within 12 months prior to screening
Subjects must have an FEV1 of at least one Liter
Subjects with a history or physician's diagnosis of asthma. If a patient has a total blood eosinophil count >/= 0.6 x 10^9/L source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition.
Subjects with hypersensitivity to the ciprofloxacin or to other quinolones and/or to inactive constituents of the inhalation powder
Subjects with known hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution
Subjects with a history of cystic fibrosis
Subjects with clinically evident bronchiectasis
Subjects taking any:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Großhansdorf | Schleswig-Holstein | 22927 | Germany |
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| Cipro Inhale (Ciprofloxacin, BAYQ3939) | Drug | 48.75 mg ciprofloxacin corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation |
|
| ID | Term |
|---|---|
| D007239 | Infections |
| 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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| 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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