Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder
Information source: Bayer
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection; Pulmonary Disease, Chronic Obstructive
Intervention: Cipro Inhale (Ciprofloxacin, BAYQ3939) (Drug); Cipro Inhale (Ciprofloxacin, BAYQ3939) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Summary
The purpose of this study is to compare the safety and pharmacokinetics of ciprofloxacin
after inhalation of single 52. 5 and 48. 75 mg doses in COPD patients. In this study the 48. 75
mg dose will be administered for the first time using a new high dose strength (i. e. one
capsule containing 75 mg powder = 48. 75 mg ciprofloxacin) formulation. Safety investigations
will focus on local tolerability in the lung and evaluate whether the patient can inhale the
higher amount of powder compared to the lower dose strength. Pharmacokinetics is to see how
the body absorbs, distributes, breaks down and gets rid of the study drug. Results from this
study will be used to decide whether the new dose strength is suitable for larger clinical
trials planned for the COPD patients population.
Clinical Details
Official title: Randomized, Double-blind, Cross-over Study in COPD Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Determination of ciprofloxacin pharmacokinetics derived from drug concentrations in blood, urine and sputum
Secondary outcome: Adverse events collection
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult subjects with COPD, 40 - 75 years of age
- All subjects must have a diagnosis of COPD and must have airway obstruction with a
post-bronchodilator Forced Expiratory Volume in 1 sec (FEV1) of >/= 30% and <= 80% of
predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of - Subjects must be current or ex-smokers with a smoking history of more than 10
pack-years
- Subjects must be able to perform technically acceptable pulmonary function tests
during the study period as required in the protocol
- Subjects must be able to produce an sufficient amount of sputum during sputum
induction at screening
Exclusion Criteria:
- Subjects with a significant respiratory disease other than COPD.
- Exacerbation within 8 weeks prior to screening
- Subjects with more than 1 COPD exacerbation within 12 months prior to screening
- Subjects must have an FEV1 of at least one Liter
- Subjects with a history or physician's diagnosis of asthma. If a patient has a total
blood eosinophil count >/= 0. 6 x 10^9/L source documentation is required to verify
that the increased eosinophil count is related to a non-asthmatic condition.
- Subjects with hypersensitivity to the ciprofloxacin or to other quinolones and/or to
inactive constituents of the inhalation powder
- Subjects with known hypersensitivity of the bronchial system to inhalation of
nebulized drugs or saline solution
- Subjects with a history of cystic fibrosis
- Subjects with clinically evident bronchiectasis
- Subjects taking any:
- Oral beta-adrenergic drugs or non cardioselective beta blockers,
- Oral glucocorticoids,
- Antihistamines or antileukotrienes prescribed for asthma,
- Oral cromolyn sodium or oral nedocromil sodium,
- Concomitant inhalative therapy with antibiotics and / or concomitant systemic
therapy with fluoroquinolones
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Großhansdorf, Schleswig-Holstein 22927, Germany; Recruiting
Additional Information
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Starting date: July 2010
Last updated: September 20, 2010
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