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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 laboratory

Electrocardiogram: 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 blood

Determination 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

Page last updated: August 23, 2015

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