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Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder

Primary Purpose

Infection, Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Cipro Inhale (Ciprofloxacin, BAYQ3939)

About this trial

This is an interventional treatment trial for Infection focused on measuring 75 mg dose strength, Safety, Pharmacokinetics

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adult subjects with COPD, 40 - 75 years of age
All subjects must have a diagnosis of COPD and must have airway obstruction with a post-bronchodilator Forced Expiratory Volume in 1 sec (FEV1) of >/= 30% and <= 80% of predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of </= 70%
Subjects must be current or ex-smokers with a smoking history of more than 10 pack-years
Subjects must be able to perform technically acceptable pulmonary function tests during the study period as required in the protocol
Subjects must be able to produce an sufficient amount of sputum during sputum induction at screening

Exclusion Criteria:

Subjects with a significant respiratory disease other than COPD.
Exacerbation within 8 weeks prior to screening
Subjects with more than 1 COPD exacerbation within 12 months prior to screening
Subjects must have an FEV1 of at least one Liter
Subjects with a history or physician's diagnosis of asthma. If a patient has a total blood eosinophil count >/= 0.6 x 10^9/L source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition.
Subjects with hypersensitivity to the ciprofloxacin or to other quinolones and/or to inactive constituents of the inhalation powder
Subjects with known hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution
Subjects with a history of cystic fibrosis
Subjects with clinically evident bronchiectasis
Subjects taking any:
- Oral beta-adrenergic drugs or non cardioselective beta blockers,
- Oral glucocorticoids,
- Antihistamines or antileukotrienes prescribed for asthma,
- Oral cromolyn sodium or oral nedocromil sodium,
- Concomitant inhalative therapy with antibiotics and / or concomitant systemic therapy with fluoroquinolones

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Determination of ciprofloxacin pharmacokinetics derived from drug concentrations in blood, urine and sputum

Secondary Outcome Measures

Adverse events collection

Full Information

NCT ID

NCT01168895

First Posted

July 19, 2010

Last Updated

April 10, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01168895

Brief Title

Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder

Official Title

Randomized, Double-blind, Cross-over Study in COPD Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare the safety and pharmacokinetics of ciprofloxacin after inhalation of single 52.5 and 48.75 mg doses in COPD patients. In this study the 48.75 mg dose will be administered for the first time using a new high dose strength (i.e. one capsule containing 75 mg powder = 48.75 mg ciprofloxacin) formulation. Safety investigations will focus on local tolerability in the lung and evaluate whether the patient can inhale the higher amount of powder compared to the lower dose strength. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this study will be used to decide whether the new dose strength is suitable for larger clinical trials planned for the COPD patients population.

6. Conditions and Keywords

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

Infection, Pulmonary Disease, Chronic Obstructive

Keywords

75 mg dose strength, Safety, Pharmacokinetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Cipro Inhale (Ciprofloxacin, BAYQ3939)

Intervention Description

32.5 mg ciprofloxacin corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation

Intervention Type

Drug

Intervention Name(s)

Cipro Inhale (Ciprofloxacin, BAYQ3939)

Intervention Description

48.75 mg ciprofloxacin corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation

Primary Outcome Measure Information:

Title

Determination of ciprofloxacin pharmacokinetics derived from drug concentrations in blood, urine and sputum

Time Frame

Within 24 hours after treatment

Secondary Outcome Measure Information:

Title

Adverse events collection

Time Frame

Within 30 days

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 subjects with COPD, 40 - 75 years of age All subjects must have a diagnosis of COPD and must have airway obstruction with a post-bronchodilator Forced Expiratory Volume in 1 sec (FEV1) of >/= 30% and <= 80% of predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of </= 70% Subjects must be current or ex-smokers with a smoking history of more than 10 pack-years Subjects must be able to perform technically acceptable pulmonary function tests during the study period as required in the protocol Subjects must be able to produce an sufficient amount of sputum during sputum induction at screening Exclusion Criteria: Subjects with a significant respiratory disease other than COPD. Exacerbation within 8 weeks prior to screening Subjects with more than 1 COPD exacerbation within 12 months prior to screening Subjects must have an FEV1 of at least one Liter Subjects with a history or physician's diagnosis of asthma. If a patient has a total blood eosinophil count >/= 0.6 x 10^9/L source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition. Subjects with hypersensitivity to the ciprofloxacin or to other quinolones and/or to inactive constituents of the inhalation powder Subjects with known hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution Subjects with a history of cystic fibrosis Subjects with clinically evident bronchiectasis Subjects taking any: Oral beta-adrenergic drugs or non cardioselective beta blockers, Oral glucocorticoids, Antihistamines or antileukotrienes prescribed for asthma, Oral cromolyn sodium or oral nedocromil sodium, Concomitant inhalative therapy with antibiotics and / or concomitant systemic therapy with fluoroquinolones

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Großhansdorf

State/Province

Schleswig-Holstein

ZIP/Postal Code

22927

Country

Germany

12. IPD Sharing Statement

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