Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
This study has been completed.
Sponsor:
Bayer
Collaborator:
Novartis
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01052298
First received: October 15, 2009
Last updated: June 14, 2012
Last verified: June 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Disease, Pulmonary |
Drug: Ciprofloxacin (Cipro inhale, BAYQ3939) Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Vital signs: evaluated by heart rate, blood pressure, clinical laboratory [ Time Frame: Within 28 days after first treatment ] [ Designated as safety issue: Yes ]
- Electrocardiogram: evaluated by shape and time intervals [ Time Frame: Within 28 days after first treatment ] [ Designated as safety issue: Yes ]
- Pulmonary function test evaluated by FEV1 [ Time Frame: Within 28 days after first treatment ] [ Designated as safety issue: Yes ]
- Pulse oximetry by peripheral oxygen concentration [ Time Frame: Within 12 days after first treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Determination of ciprofloxacin concentration in blood [ Time Frame: Within 14 days after first treatment ] [ Designated as safety issue: No ]
- Determination of ciprofloxacin concentration in urine [ Time Frame: Within 14 days after first treatment ] [ Designated as safety issue: No ]
- Determination of ciprofloxacin concentration in sputum [ Time Frame: Within 14 days after first treatment ] [ Designated as safety issue: No ]
- Determination of ciprofloxacin concentration in oral rinsing fluid [ Time Frame: Within 7 days after first treatment ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | April 2009 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)
32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.
|
| Experimental: Arm 2 |
Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)
32.5 mg ciprofloxacin betaine corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given three times daily (tid) with a concluding single dose on 11d.
|
| Experimental: Arm 3 |
Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)
48.75 mg ciprofloxacin betaine corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as an initial single dose application on day 00d.During the multiple dose phase (day 02d to 10d) the same dose will be given twice daily (bid) with a concluding single dose on 11d.
|
| Placebo Comparator: Arm 4 |
Drug: Placebo
Placebo inhalation powder will be given as an initial single dose inhalation on 00d.During the multiple dose phase placebo will be given twice/three-times daily with a concluding single dose on day 11d.
|
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Head Clinical Pharmacology, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01052298 History of Changes |
| Other Study ID Numbers: | 13013, 2008-006770-14 |
| Study First Received: | October 15, 2009 |
| Last Updated: | June 14, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Bayer:
|
Ciprofloxacin Inhalation Pharmacokinetics |
Safety Tolerability COPD |
Additional relevant MeSH terms:
|
Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases 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 21, 2013