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

Phase 1

Completed

• Conditions: Disease, Pulmonary
• Interventions: Drug: Ciprofloxacin (Cipro inhale, BAYQ3939); Drug: Placebo

• Registration Number: NCT01052298
• Lead Sponsor: Bayer

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	Ciprofloxacin (Cipro inhale, BAYQ3939)	-
Arm 1	Ciprofloxacin (Cipro inhale, BAYQ3939)	-
Arm 2	Ciprofloxacin (Cipro inhale, BAYQ3939)	-
Arm 4	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Determination of ciprofloxacin concentration in blood	Within 14 days after first treatment
Determination of ciprofloxacin concentration in urine	Within 14 days after first treatment
Determination of ciprofloxacin concentration in sputum	Within 14 days after first treatment
Determination of ciprofloxacin concentration in oral rinsing fluid	Within 7 days after first treatment