Clinical trial NCT01052298: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Disease, Pulmonary
Keywords: Ciprofloxacin
Inhalation
Pharmacokinetics
Safety
Tolerability
COPD
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2010-01-20
Enrollment: 25
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Vital signs: evaluated by heart rate, blood pressure, clinical laboratory
timeFrame: Within 28 days after first treatment
measure: Electrocardiogram: evaluated by shape and time intervals
timeFrame: Within 28 days after first treatment
measure: Pulmonary function test evaluated by FEV1
timeFrame: Within 28 days after first treatment
measure: Pulse oximetry by peripheral oxygen concentration
timeFrame: Within 12 days after first treatment
Secondary outcomes:
measure: Determination of ciprofloxacin concentration in blood
timeFrame: Within 14 days after first treatment
measure: Determination of ciprofloxacin concentration in urine
timeFrame: Within 14 days after first treatment
measure: Determination of ciprofloxacin concentration in sputum
timeFrame: Within 14 days after first treatment
measure: Determination of ciprofloxacin concentration in oral rinsing fluid
timeFrame: Within 7 days after first treatment
Other outcomes:
Locations:
city: Mannheim
country: Germany
state: Baden-Württemberg
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: