Trial Condition(s):

Anthrax, Bacterial Infections, Cystic Fibrosis

BAYQ3939, PK in pediatric CF patients

Bayer Identifier:

12170

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2007-002912-24

EU CT Number:

Not Available

Study Completed

Trial Purpose

Primary objective:
To investigate the safety and tolerability of inhaled ciprofloxacin given as single inhalation dose to pediatric CF subjects.
Secondary objective:
To investigate the pharmacokinetics of ciprofloxacin in plasma, urine, and sputum after inhalative administration in order to show that an exposure needed for an assumed effective treatment of P. aeruginosa can be reached in the lung of pediatric CF subjects.

Inclusion Criteria

- Adolescents with CF aged 12 - 17 years (BMI between 15 and 30 kg/m2) with stable pulmonary status, i.e., forced expiratory volume in 1 s (FEV1) ≥50%

Exclusion Criteria

- Participation in another clinical trial with antibiotic treatment during the preceding 2 weeks
      - Patients with FEV1 < 50%

Trial Summary

Enrollment Goal

Trial Dates

November2007

April2008

Phase

Could I receive a placebo?

Products

Ciprofloxacin DPI (BAYQ3939)

Accepts Healthy Volunteers

Where to Participate

Locations

Locations

Anthrax, Bacterial Infections, Cystic Fibrosis

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

EU CT Number:

Trial Purpose

Key Participation Requirements

sex

age

12 Years

17 Years

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

For details, please refer to trial results

Additional Information