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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Disease, Pulmonary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Ciprofloxacin (Cipro inhale, BAYQ3939)

Intervention Type DRUG

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.

Arm 2

Group Type EXPERIMENTAL

Ciprofloxacin (Cipro inhale, BAYQ3939)

Intervention Type DRUG

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.

Arm 3

Group Type EXPERIMENTAL

Ciprofloxacin (Cipro inhale, BAYQ3939)

Intervention Type DRUG

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.

Arm 4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No