Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsor:	Bayer
Collaborator:	Novartis Pharmaceuticals
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00961038

Purpose

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 moderate to severe COPD (stage II-III according to GOLD Criteria)

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Ciprofloxacin (PulmoSphere, BAYQ3939) Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Randomized, Single-Blinded, Placebo-Controlled Study to Evaluate the Safety and Tolerability, the Pulmonary Deposition and Pharmacokinetics of Ciprofloxacin in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (GOLD II - III), Following Inhalation of Ciprofloxacin PulmoSphere® Inhalation Powder

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Vital signs [ Time Frame: Within 28 days after first treatment ] [ Designated as safety issue: Yes ]
Electrocardiogram (ECG) [ Time Frame: Within 28 days after first treatment ] [ Designated as safety issue: Yes ]
Pulmonary function test [ Time Frame: Within 28 days after first treatment ] [ Designated as safety issue: Yes ]
Pulse-oximetry [ Time Frame: Within 12 days after first treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Ciprofloxacin concentrations in blood [ Time Frame: Within 14 days after first treatment ] [ Designated as safety issue: No ]
Ciprofloxacin concentrations in urine [ Time Frame: Within 14 days after first treatment ] [ Designated as safety issue: No ]
Ciprofloxacin concentrations in sputum [ Time Frame: Within 14 days after first treatment ] [ Designated as safety issue: No ]
Ciprofloxacin concentrations in mouth fluid [ Time Frame: Within 7 days after first treatment ] [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	August 2009
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Ciprofloxacin (PulmoSphere, BAYQ3939) 32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin PulmoSphere inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), the same dose will be given twice daily, with a concluding single dose (on day 12)
Experimental: Arm 2	Drug: Ciprofloxacin (PulmoSphere, BAYQ3939) 48,75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin PulmoSphere inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), the same dose will be given twice daily, with a concluding single dose (on day 12)
Placebo Comparator: Arm 3	Drug: Placebo Placebo inhalation powder will be given as an initial single-dose inhalation (day 0).During the multiple-dose phase (day 2 to day 11), placebo will be given twice daily, with a concluding single dose (on day 12)

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients with COPD, 40 to 75 years of age
Diagnosis of COPD
Airway obstruction with a post-bronchodilator Forced Expiratory Volume (FEV1) of >/=30% and </=65% of predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of </=70%
Current or ex-smokers with a smoking history of more than 10 pack-years
Patients must be able to produce acceptable induced sputum samples (as defined in the Study Procedure Manual)
Normal body weight: Body Mass Index (BMI) between 19 and 35 kg/m2

Exclusion Criteria:

Significant respiratory disease other than COPD as bronchial asthma, Cystic fibrosis or clinically evident bronchiectasis
More than one COPD exacerbation within 12 months and within 8 weeks prior to screening
total blood eosinophil count >/=600/mm3
Thoracotomy with pulmonary resection
Regularly use of daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
Hypersensitivity to the investigational drug or to other quinolones and/or to inactive constituents of the inhalation powder
Hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution
Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
Concomitant use of medication which could interfere with the investigational drug. Before study drug administration a wash out period of more than 5 half lives has to be considered
Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with
- fluoroquinolones
- Oral beta-adrenergics, beta blockers
- oral steroids
- Methylxanthines: 24-hour washout of short-acting theophylline and 48-hour washout of long-acting theophylline prior to pre-study examination
- Antihistamines, antileukotrienes prescribed for asthma
- oral cromolyn sodium or oral nedocromil sodium

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961038

Locations

Germany

Hannover, Niedersachsen, Germany, 30625

Sponsors and Collaborators

Bayer

Novartis Pharmaceuticals

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Head Clinical Pharmacology, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier:	NCT00961038 History of Changes
Other Study ID Numbers:	13014, EudraCT: 2008-006771-79
Study First Received:	August 17, 2009
Last Updated:	December 27, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Ciprofloxacin
Inhalation
Pharmacokinetics

Safety
Tolerability
COPD

Additional relevant MeSH terms:

Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012