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

Primary Purpose

Disease, Pulmonary

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Ciprofloxacin (Cipro inhale, BAYQ3939)

Placebo

About this trial

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

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

Outcomes

Primary Outcome Measures

Vital signs: evaluated by heart rate, blood pressure, clinical laboratory

Electrocardiogram: evaluated by shape and time intervals

Pulmonary function test evaluated by FEV1

Pulse oximetry by peripheral oxygen concentration

Secondary Outcome Measures

Determination of ciprofloxacin concentration in blood

Determination of ciprofloxacin concentration in urine

Determination of ciprofloxacin concentration in sputum

Determination of ciprofloxacin concentration in oral rinsing fluid

Full Information

NCT ID

NCT01052298

First Posted

October 15, 2009

Last Updated

May 29, 2013

Sponsor

Bayer

Collaborators

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT01052298

Brief Title

Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Mild to Moderate 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 Mild to Moderate Chronic Obstructive Pulmonary Disease (GOLD I - II), Following Inhalation of Ciprofloxacin PulmoSphere Inhalation Powder.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bayer

Collaborators

Novartis

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

6. Conditions and Keywords

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

Disease, Pulmonary

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

25 (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

Experimental

Arm Title

Arm 4

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Ciprofloxacin (Cipro inhale, BAYQ3939)

Intervention Description

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

Intervention Name(s)

Ciprofloxacin (Cipro inhale, BAYQ3939)

Intervention Description

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

Intervention Name(s)

Ciprofloxacin (Cipro inhale, BAYQ3939)

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Vital signs: evaluated by heart rate, blood pressure, clinical laboratory

Time Frame

Within 28 days after first treatment

Title

Electrocardiogram: evaluated by shape and time intervals

Time Frame

Within 28 days after first treatment

Title

Pulmonary function test evaluated by FEV1

Time Frame

Within 28 days after first treatment

Title

Pulse oximetry by peripheral oxygen concentration

Time Frame

Within 12 days after first treatment

Secondary Outcome Measure Information:

Title

Determination of ciprofloxacin concentration in blood

Time Frame

Within 14 days after first treatment

Title

Determination of ciprofloxacin concentration in urine

Time Frame

Within 14 days after first treatment

Title

Determination of ciprofloxacin concentration in sputum

Time Frame

Within 14 days after first treatment

Title

Determination of ciprofloxacin concentration in oral rinsing fluid

Time Frame

Within 7 days after first treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Mannheim

State/Province

Baden-Württemberg

ZIP/Postal Code

68167

Country

Germany

12. IPD Sharing Statement

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

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