Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Disease, Pulmonary
Intervention: Ciprofloxacin (Cipro inhale, BAYQ3939) (Drug); Ciprofloxacin (Cipro inhale, BAYQ3939) (Drug); Ciprofloxacin (Cipro inhale, BAYQ3939) (Drug); Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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).
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Vital signs: evaluated by heart rate, blood pressure, clinical laboratoryElectrocardiogram: evaluated by shape and time intervals Pulmonary function test evaluated by FEV1 Pulse oximetry by peripheral oxygen concentration
Secondary outcome: Determination of ciprofloxacin concentration in bloodDetermination of ciprofloxacin concentration in urine Determination of ciprofloxacin concentration in sputum Determination of ciprofloxacin concentration in oral rinsing fluid
Eligibility
Minimum age: 35 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Mannheim, Baden-Württemberg 68167, Germany
Additional Information
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Starting date: April 2009
Last updated: May 29, 2013
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