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

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: Ciprofloxacin (PulmoSphere, BAYQ3939) (Drug); Ciprofloxacin (PulmoSphere, BAYQ3939) (Drug); Placebo (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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).

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

Study design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety Study

Primary outcome:

Vital signs

Electrocardiogram (ECG)

Pulmonary function test

Pulse-oximetry

Secondary outcome:

Ciprofloxacin concentrations in blood

Ciprofloxacin concentrations in urine

Ciprofloxacin concentrations in sputum

Ciprofloxacin concentrations in mouth fluid

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.

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 - 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

investigator178s 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

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Hannover, Niedersachsen 30625, Germany; Recruiting

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Starting date: August 2009
Ending date: December 2009
Last updated: September 23, 2009