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

Disease, Pulmonary Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052298
• Other study ID #: 13013
• Secondary ID: 2008-006770-14
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2009
• Last updated: May 29, 2013
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: May 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Disease, Pulmonary
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital signs: evaluated by heart rate, blood pressure, clinical laboratory		Within 28 days after first treatment	Yes
Primary	Electrocardiogram: evaluated by shape and time intervals		Within 28 days after first treatment	Yes
Primary	Pulmonary function test evaluated by FEV1		Within 28 days after first treatment	Yes
Primary	Pulse oximetry by peripheral oxygen concentration		Within 12 days after first treatment	Yes
Secondary	Determination of ciprofloxacin concentration in blood		Within 14 days after first treatment	No
Secondary	Determination of ciprofloxacin concentration in urine		Within 14 days after first treatment	No
Secondary	Determination of ciprofloxacin concentration in sputum		Within 14 days after first treatment	No
Secondary	Determination of ciprofloxacin concentration in oral rinsing fluid		Within 7 days after first treatment	No

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