Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder
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ClinicalTrials.gov Identifier: NCT01168895 |
Recruitment Status :
Completed
First Posted : July 23, 2010
Last Update Posted : April 14, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infection Pulmonary Disease, Chronic Obstructive | Drug: Cipro Inhale (Ciprofloxacin, BAYQ3939) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Double-blind, Cross-over Study in COPD Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 |
Drug: Cipro Inhale (Ciprofloxacin, BAYQ3939)
32.5 mg ciprofloxacin corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation |
Experimental: Arm 2 |
Drug: Cipro Inhale (Ciprofloxacin, BAYQ3939)
48.75 mg ciprofloxacin corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation |
- Determination of ciprofloxacin pharmacokinetics derived from drug concentrations in blood, urine and sputum [ Time Frame: Within 24 hours after treatment ]
- Adverse events collection [ Time Frame: Within 30 days ]

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Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Adult subjects with COPD, 40 - 75 years of age
- All subjects must have a diagnosis of COPD and must have airway obstruction with a post-bronchodilator Forced Expiratory Volume in 1 sec (FEV1) of >/= 30% and <= 80% of predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of </= 70%
- Subjects must be current or ex-smokers with a smoking history of more than 10 pack-years
- Subjects must be able to perform technically acceptable pulmonary function tests during the study period as required in the protocol
- Subjects must be able to produce an sufficient amount of sputum during sputum induction at screening
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
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Subjects taking any:
- Oral beta-adrenergic drugs or non cardioselective beta blockers,
- Oral glucocorticoids,
- Antihistamines or antileukotrienes prescribed for asthma,
- Oral cromolyn sodium or oral nedocromil sodium,
- Concomitant inhalative therapy with antibiotics and / or concomitant systemic therapy with fluoroquinolones

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168895
Germany | |
Großhansdorf, Schleswig-Holstein, Germany, 22927 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT01168895 |
Other Study ID Numbers: |
14972 2010-018521-19 ( EudraCT Number ) |
First Posted: | July 23, 2010 Key Record Dates |
Last Update Posted: | April 14, 2014 |
Last Verified: | April 2014 |
75 mg dose strength Safety Pharmacokinetics |
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