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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infection Chronic Disease Disease Attributes Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Großhansdorf, Schleswig-Holstein, 22927, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 </= 70%
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

Treatment and study plan

Cipro Inhale (Ciprofloxacin, BAYQ3939)

Drug

32.5 mg ciprofloxacin corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation

Primary outcomes

Determination of ciprofloxacin pharmacokinetics derived from drug concentrations in blood, urine and sputum

Time frame: Within 24 hours after treatment

Secondary outcomes

Adverse events collection

Time frame: Within 30 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jul 23, 2010
Registry last updated: Apr 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed