Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)

NCT01052298 | Completed Phase 1

• 2 other identifiers: 130132008-006770-14
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Disease, Pulmonary

Keywords

Ciprofloxacin; Inhalation; Pharmacokinetics; Safety; Tolerability; COPD

Outcome Measures

Primary Outcomes (4)

• Vital signs: evaluated by heart rate, blood pressure, clinical laboratory

  Within 28 days after first treatment

• Electrocardiogram: evaluated by shape and time intervals

  Within 28 days after first treatment

• Pulmonary function test evaluated by FEV1

  Within 28 days after first treatment

• Pulse oximetry by peripheral oxygen concentration

  Within 12 days after first treatment

Secondary Outcomes (4)

• Determination of ciprofloxacin concentration in blood

  Within 14 days after first treatment

• Determination of ciprofloxacin concentration in urine

  Within 14 days after first treatment

• Determination of ciprofloxacin concentration in sputum

  Within 14 days after first treatment

• Determination of ciprofloxacin concentration in oral rinsing fluid

  Within 7 days after first treatment

Study Arms (4)

Arm 1

EXPERIMENTAL

Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)

Arm 2

EXPERIMENTAL

Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)

Arm 3

EXPERIMENTAL

Drug: Ciprofloxacin (Cipro inhale, BAYQ3939)

Arm 4

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ciprofloxacin (Cipro inhale, BAYQ3939) DRUG

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.

Arm 1

Placebo DRUG

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.

Arm 4

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Novartis: collaborator

Study Sites (1)

Unknown Facility

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

MeSH Terms

Conditions

Lung Diseases; Respiratory Aspiration; Pulmonary Disease, Chronic Obstructive

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: January 20, 2010
• Study Start: April 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

DE (1)