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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961038
• Other study ID #: 13014
• Secondary ID: 2008-006771-79
• Status: Completed
• Phase: Phase 1
• First received: August 17, 2009
• Last updated: March 31, 2014
• Start date: August 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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-andrenergics, 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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)
• 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
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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital signs		Within 28 days after first treatment	Yes
Primary	Electrocardiogram (ECG)		Within 28 days after first treatment	Yes
Primary	Pulmonary function test		Within 28 days after first treatment	Yes
Primary	Pulse-oximetry		Within 12 days after first treatment	Yes
Secondary	Ciprofloxacin concentrations in blood		Within 14 days after first treatment	No
Secondary	Ciprofloxacin concentrations in urine		Within 14 days after first treatment	No
Secondary	Ciprofloxacin concentrations in sputum		Within 14 days after first treatment	No
Secondary	Ciprofloxacin concentrations in mouth fluid		Within 7 days after first treatment	No

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