Trials / Withdrawn
WithdrawnNCT01090908
Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. Aeruginosa
A Multi-Center, Open Label Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Ciprofloxacin For Inhalation (CFI) Given Daily For 14 Days To Stable Cystic Fibrosis Patients Ages 6 To 17 With Pseudomonas Aeruginosa
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Aradigm Corporation · Industry
- Sex
- All
- Age
- 6 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection.
Detailed description
This is a Phase 1/2a, multicenter study, designed to evaluate the pharmacokinetics, safety, and tolerability of once daily administration of 150 mg of Ciprofloxacin for Inhalation (CFI) in patients with Cystic Fibrosis who have a history of chronic P. aeruginosa lung infection. Patients will be enrolled and followed in this study for 1 month. This study will consist of a Screening Phase, a Treatment Phase consisting of a 14 days, and a Follow up Phase consisting of a 14 days Off-treatment Period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Antibiotic |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2011-03-01
- Completion
- 2011-06-01
- First posted
- 2010-03-23
- Last updated
- 2023-11-22
Source: ClinicalTrials.gov record NCT01090908. Inclusion in this directory is not an endorsement.