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
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01168895
First received: July 19, 2010
Last updated: March 21, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infection Pulmonary Disease, Chronic Obstructive |
Drug: Cipro Inhale (Ciprofloxacin, BAYQ3939) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Determination of ciprofloxacin pharmacokinetics derived from drug concentrations in blood, urine and sputum [ Time Frame: Within 24 hours after treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events collection [ Time Frame: Within 30 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 12 |
| Study Start Date: | July 2010 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Cipro Inhale (Ciprofloxacin, BAYQ3939)
32.5 mg ciprofloxacin corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation
|
| Experimental: Arm 2 |
Drug: Cipro Inhale (Ciprofloxacin, BAYQ3939)
48.75 mg ciprofloxacin corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation
|
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 </= 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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Head Clinical Pharmacology, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT01168895 History of Changes |
| Other Study ID Numbers: | 14972, 2010-018521-19 |
| Study First Received: | July 19, 2010 |
| Last Updated: | March 21, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Bayer:
|
75 mg dose strength Safety Pharmacokinetics |
Additional relevant MeSH terms:
|
Respiratory Aspiration Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Disease Attributes Pathologic Processes Ciprofloxacin Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013