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

This study has been completed.

Sponsor:

Collaborator:

Novartis

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT01052298

First received: October 15, 2009

Last updated: June 14, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 15, 2009

Last Updated Date

June 14, 2012

Start Date ^ICMJE

April 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Vital signs: evaluated by heart rate, blood pressure, clinical laboratory [ Time Frame: Within 28 days after first treatment ] [ Designated as safety issue: Yes ]
Electrocardiogram: evaluated by shape and time intervals [ Time Frame: Within 28 days after first treatment ] [ Designated as safety issue: Yes ]
Pulmonary function test evaluated by FEV1 [ Time Frame: Within 28 days after first treatment ] [ Designated as safety issue: Yes ]
Pulse oximetry by peripheral oxygen concentration [ Time Frame: Within 12 days after first treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01052298 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Determination of ciprofloxacin concentration in blood [ Time Frame: Within 14 days after first treatment ] [ Designated as safety issue: No ]
Determination of ciprofloxacin concentration in urine [ Time Frame: Within 14 days after first treatment ] [ Designated as safety issue: No ]
Determination of ciprofloxacin concentration in sputum [ Time Frame: Within 14 days after first treatment ] [ Designated as safety issue: No ]
Determination of ciprofloxacin concentration in oral rinsing fluid [ Time Frame: Within 7 days after first treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Disease, Pulmonary

Intervention ^ICMJE

Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)
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.
Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)
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.
Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)
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.
Drug: Placebo
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.

Study Arm (s)

Experimental: Arm 1
Intervention: Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)
Experimental: Arm 2
Intervention: Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)
Experimental: Arm 3
Intervention: Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)
Placebo Comparator: Arm 4
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

35 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01052298

Other Study ID Numbers ^ICMJE

13013, 2008-006770-14

Has Data Monitoring Committee

Responsible Party

Head Clinical Pharmacology, Bayer Healthcare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Novartis

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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