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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Ciprofloxacin (PulmoSphere, BAYQ3939)

Placebo

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Ciprofloxacin, Inhalation, Pharmacokinetics, Safety, Tolerability, COPD

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

Vital signs

Electrocardiogram (ECG)

Pulmonary function test

Pulse-oximetry

Secondary Outcome Measures

Ciprofloxacin concentrations in blood

Ciprofloxacin concentrations in urine

Ciprofloxacin concentrations in sputum

Ciprofloxacin concentrations in mouth fluid

Full Information

NCT ID

NCT00961038

First Posted

August 17, 2009

Last Updated

March 31, 2014

Sponsor

Bayer

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00961038

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

Collaborators

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. 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 moderate to severe COPD (stage II-III according to GOLD Criteria)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

Keywords

Ciprofloxacin, Inhalation, Pharmacokinetics, Safety, Tolerability, COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Experimental

Arm Title

Arm 3

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Ciprofloxacin (PulmoSphere, BAYQ3939)

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Ciprofloxacin (PulmoSphere, BAYQ3939)

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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)

Primary Outcome Measure Information:

Title

Vital signs

Time Frame

Within 28 days after first treatment

Title

Electrocardiogram (ECG)

Time Frame

Within 28 days after first treatment

Title

Pulmonary function test

Time Frame

Within 28 days after first treatment

Title

Pulse-oximetry

Time Frame

Within 12 days after first treatment

Secondary Outcome Measure Information:

Title

Ciprofloxacin concentrations in blood

Time Frame

Within 14 days after first treatment

Title

Ciprofloxacin concentrations in urine

Time Frame

Within 14 days after first treatment

Title

Ciprofloxacin concentrations in sputum

Time Frame

Within 14 days after first treatment

Title

Ciprofloxacin concentrations in mouth fluid

Time Frame

Within 7 days after first treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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 </=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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

12. IPD Sharing Statement

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

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