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

Bayer

Status and phase

Completed

Phase 1

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Placebo

Drug: Ciprofloxacin (PulmoSphere, BAYQ3939)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00961038

13014

2008-006771-79 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment

19 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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