check_circleStudy Completed

Pulmonary Disease, Chronic Obstructive

Bayer Identifier:

13014

ClinicalTrials.gov Identifier:

NCT00961038

EudraCT Number:

2008-006771-79

EU CT Number:

Not Available
Study to evaluate the safety and pharmacokinetics of inhaled ciprofloxacin in patients with moderate to severe 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 moderate to severe COPD (stage II-III according to GOLD Criteria)

Key Participants Requirements

Sex

Both

Age

40 - 75 Years
  • - Adult patients with COPD, 40 to 75 years of age
    - Diagnosis of COPD
    - Airway obstruction with a post-bronchodilator Forced Expiratory Volume (FEV1) of >/=30% and - Current or ex-smokers with a smoking history of more than 10 pack-years
    - Patients must be able to produce acceptable induced sputum samples (as defined in the Study Procedure Manual)
    - Normal body weight: Body Mass Index (BMI) between 19 and 35 kg/m2
  • - Significant respiratory disease other than COPD as bronchial asthma, Cystic fibrosis or clinically evident bronchiectasis
    - More than one COPD exacerbation within 12 months and within 8 weeks prior to screening
    - total blood eosinophil count >/=600/mm3
    - Thoracotomy with pulmonary resection
    - Regularly use of daytime oxygen therapy for more than one hour per day and in the investigator’s opinion will be unable to abstain from the use of oxygen therapy during clinic visits
    - 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
    - Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
    - Concomitant use of medication which could interfere with the investigational drug. Before study drug administration a wash out period of more than 5 half lives has to be considered
    - Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with
     -- fluoroquinolones
     -- Oral beta-andrenergics, beta blockers
     -- 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
19
Trial Dates
August 2009 - March 2010
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hannover, 30625, Germany

Primary Outcome

  • Vital signs
    date_rangeTime Frame:
    Within 28 days after first treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Electrocardiogram (ECG)
    date_rangeTime Frame:
    Within 28 days after first treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Pulmonary function test
    date_rangeTime Frame:
    Within 28 days after first treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Pulse-oximetry
    date_rangeTime Frame:
    Within 12 days after first treatment
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Ciprofloxacin concentrations in blood
    date_rangeTime Frame:
    Within 14 days after first treatment
    enhanced_encryption
    Safety Issue:
    no
  • Ciprofloxacin concentrations in urine
    date_rangeTime Frame:
    Within 14 days after first treatment
    enhanced_encryption
    Safety Issue:
    no
  • Ciprofloxacin concentrations in sputum
    date_rangeTime Frame:
    Within 14 days after first treatment
    enhanced_encryption
    Safety Issue:
    no
  • Ciprofloxacin concentrations in mouth fluid
    date_rangeTime Frame:
    Within 7 days after first treatment
    enhanced_encryption
    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 Moderate to Severe Chronic Obstructive Pulmonary Disease (GOLD II - III), 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
3

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.