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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01052298

Collaborator

Novartis (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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 mild to moderate COPD (stage I-II according to GOLD Criteria).

Condition or Disease	Intervention/Treatment	Phase
Disease, Pulmonary	Drug: Ciprofloxacin (Cipro inhale, BAYQ3939) Drug: Ciprofloxacin (Cipro inhale, BAYQ3939) Drug: Ciprofloxacin (Cipro inhale, BAYQ3939) Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

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 Mild to Moderate Chronic Obstructive Pulmonary Disease (GOLD I - II), Following Inhalation of Ciprofloxacin PulmoSphere Inhalation Powder.

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Ciprofloxacin (Cipro inhale, BAYQ3939) 32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.
Experimental: Arm 2	Drug: Ciprofloxacin (Cipro inhale, BAYQ3939) 32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given three times daily (tid) with a concluding single dose on 11d.
Experimental: Arm 3	Drug: Ciprofloxacin (Cipro inhale, BAYQ3939) 48.75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.
Placebo Comparator: Arm 4	Drug: Placebo Placebo inhalation powder will be given as an initial single dose inhalation on 00d.During the multiple dose phase placebo will be given twice/three-times daily with a concluding single dose on day 11d.

Outcome Measures

Primary Outcome Measures

Vital signs: evaluated by heart rate, blood pressure, clinical laboratory [Within 28 days after first treatment]
Electrocardiogram: evaluated by shape and time intervals [Within 28 days after first treatment]
Pulmonary function test evaluated by FEV1 [Within 28 days after first treatment]
Pulse oximetry by peripheral oxygen concentration [Within 12 days after first treatment]

Secondary Outcome Measures

Determination of ciprofloxacin concentration in blood [Within 14 days after first treatment]
Determination of ciprofloxacin concentration in urine [Within 14 days after first treatment]
Determination of ciprofloxacin concentration in sputum [Within 14 days after first treatment]
Determination of ciprofloxacin concentration in oral rinsing fluid [Within 7 days after first treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients with COPD (Stage I or II according to the GOLD Classification), 35 years of age or older
Airway obstruction with a post-bronchodilator Forced Expiratory Volume (FEV1) > or equal 50% of predicted normal and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) < 70%.
Current or ex-smokers with a smoking history of more than 10 pack-years
Body mass index (BMI) between 18 and 33 kg/m2
Written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures

Exclusion Criteria:

Significant disease other than COPD as bronchial asthma, cystic fibrosis or clinically evident bronchiectasis
Total blood eosinophil count >/=600/mm3.
Thoracotomy with pulmonary resection
Regular use of daytime oxygen therapy
Completion of a pulmonary rehabilitation program in the six weeks prior to the pre-study examination or current participation in a rehabilitation program
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
Acute pulmonary exacerbation
Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with fluoroquinolones
Oral beta-adrenergics, beta blockers
Long acting anti-cholinergics within 2 weeks prior to pre-study examination
Inhaled or 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