Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection
NCT01055847 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2010-01-26
Summary
This is multicenter placebo-controlled study evaluating the safety and efficacy of AI at two dosage levels compared to placebo in CF patients with P. aeruginosa lung infection.
Conditions
- Cystic Fibrosis
- CF
- Lung Infection
- Pseudomonas Aeruginosa
Interventions
- DRUG
-
Aztreonam for Inhalation (AI)
Aztreonam for Inhalation
- DRUG
-
Saline Placebo
Sponsors & Collaborators
-
Salus Pharma, Inc.
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Ronald L Gibson, Jr., MD · Children's Hospital and Regional Medica Center, Seattle, WA
-
George Retsch-Bogart, MD · University of North Carolina Hospitals, Chapel Hill, NC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-06-30
- Primary Completion
- 2004-08-31
- Completion
- 2004-09-30
Countries
- United States
Study Locations
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