Study Completed

Disease, Pulmonary

Bayer Identifier:

13013

ClinicalTrials.gov Identifier:

NCT01052298

EudraCT Number:

2008-006770-14

EU CT Number:

Not Available

Study to evaluate the safety and pharmacokinetics of inhaled ciprofloxacin in patients with mild to moderate chronic obstructive pulmonary disease (COPD)

Trial purpose

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).

Key Participants Requirements

Sex

Both

Age

35 Years

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

Trial summary

Enrollment Goal

Trial Dates

April 2009 - September 2009

Phase

Phase 1

Could I Receive a placebo

Yes

Products

Ciprofloxacin DPI (BAYQ3939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	CRS Clinical-Research-Services Mannheim GmbH	Mannheim, 68167, Germany

Primary Outcome

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

Secondary Outcome

Determination of ciprofloxacin concentration in blood
Time Frame:
Within 14 days after first treatment
Safety Issue:
no
Determination of ciprofloxacin concentration in urine
Time Frame:
Within 14 days after first treatment
Safety Issue:
no
Determination of ciprofloxacin concentration in sputum
Time Frame:
Within 14 days after first treatment
Safety Issue:
no
Determination of ciprofloxacin concentration in oral rinsing fluid
Time Frame:
Within 7 days after first treatment
Safety Issue:
no

Trial design

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.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Single Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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