Study to Characterize Lung Deposition, Pharmacokinetics, Safety and Tolerability of Single Inhalations of Radiolabeled Ciprofloxacin Dry Powder in Healthy Subjects and Patients With Chronic Lung Diseases

NCT ID: NCT01538667

Last Updated: 2014-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-07-31

Brief Summary

The purpose of this study is to characterize variability and extent of the deposition of ciprofloxacin in the respiratory tract of healthy subjects in comparison to patients with chronic lung diseases after inhalation of a single 50 mg dry powder dose containing 32 mg active substance. In addition the safety and pharmacokinetics of ciprofloxacin will be evaluated. In this study the radiolabeled substance will be administered and scintigraphy imaging techniques will be used to demonstrate the lung deposition visually. In the healthy subjects an additional pharmacokinetic method is used to calculate lung deposition indirectly based on pharmacokinetic data derived from plasma. For this purpose they will inhale at a separate occasion another dose of ciprofloxacin after having ingested activated charcoal. The latter serves to bind ciprofloxacin which is swallowed down during the inhalation maneuver in the gastrointestinal (GI) tract, thus preventing its uptake into the blood (charcoal block). Safety investigations will focus on local tolerability in the lung.

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 show how the drug is distributed in the human lung.

Conditions

Respiratory System

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Ciprofloxacin (Cipro Inhale, BAYQ3939)

Intervention Type: DRUG

50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects

Arm 2

Group Type: EXPERIMENTAL

Ciprofloxacin (Cipro Inhale, BAYQ3939)

Intervention Type: DRUG

50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects under charcoal block

Arm 3

Group Type: EXPERIMENTAL

Ciprofloxacin (Cipro Inhale, BAYQ3939)

Intervention Type: DRUG

50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by COPD patients

Arm 4

Group Type: EXPERIMENTAL

Ciprofloxacin (Cipro Inhale, BAYQ3939)

Intervention Type: DRUG

50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by bronchiectasis patients

Interventions

Ciprofloxacin (Cipro Inhale, BAYQ3939)

50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects

Intervention Type: DRUG

Ciprofloxacin (Cipro Inhale, BAYQ3939)

50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects under charcoal block

Intervention Type: DRUG

Ciprofloxacin (Cipro Inhale, BAYQ3939)

50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by COPD patients

Intervention Type: DRUG

Ciprofloxacin (Cipro Inhale, BAYQ3939)

50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by bronchiectasis patients

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Understanding of the study and written informed consent prior to any study-related procedures

• Age: 18 to 65 years (inclusive) at screening visit
• Males
• Non- or ex-smokers who smoked < 5 pack-years and stopped smoking > 1 year prior to screening visit
• Results of laboratory tests within the normal ranges; minor deviations are acceptable provided that they are not judged clinically significant by the investigator

• Age: 40 to 70 years (inclusive) at screening visit
• Males and females
• All patients must have a diagnosis of COPD of Stage II or III according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) Classification (post-bronchodilator forced expiratory volume in 1 second (FEV1): 80% > FEV1 ≥ 30% of predicted values and a post-bronchodilator FEV1/FVC ≤ 70% (FVC = forced vital capacity)
• Minimum smoking history of 10 pack-years

• Age: 18 to 75 years (inclusive) at screening visit
• Males and females
• Diagnosis of bronchiectasis

Exclusion Criteria

• Known hypersensitivity, allergy or intolerance to study drug formulation ingredients
• Febrile illness within 1 week prior to screening visit
• Concomitant severe diseases (judged by the investigator) or diseases which are contraindications for the use of inhaled ciprofloxacin
• Use of ciprofloxacin within 30 days before screening visit
• Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them, e.g. systemic administration of antibiotics which are subject to renal excretion (e.g. beta-lactam antibiotics, levofloxacin, ofloxacin, etc.), furosemide and antacids
• Donation of more than 450 mL of blood within 4 weeks before screening visit
• Clinically relevant findings in the ECG
• Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation
• Participation in another clinical study less than 8 weeks prior to screening visit
• Pulmonary exacerbation within the 6 weeks prior to screening
• History of lung transplant or any lung surgery or on any thoracic surgery waiting list

• Lung function measurements outside normal limits (Normal values: FEV1/FVC > 70% and FEV1 and FVC > 80% of predicted)

• Regular use of daytime oxygen therapy
• Diagnosis of bronchial asthma
• Diagnosis of clinically evident bronchiectasis (COPD patients)
• Total blood eosinophil count >/= 600/mm3.
• Completion of a pulmonary rehabilitation program in the six weeks prior to screening visit or current participation in a pulmonary rehabilitation program
• Change in dose or type of any medications within 4 weeks prior to the screening visit

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Gauting, Bavaria, Germany

Countries

Germany

Other Identifiers

2011-000342-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11523

Identifier Type: -

Identifier Source: org_study_id