Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection
NCT00499720 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2011-08-02
Summary
The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa airway infection who have limited treatment options and are at risk for disease progression.
Conditions
- Cystic Fibrosis
- Pseudomonas Aeruginosa Airway Infection
Interventions
- DRUG
-
Aztreonam Lysine for Inhalation
75 mg three times a day via inhalation for 28 days followed by 28 days off drug.
Sponsors & Collaborators
- lead INDUSTRY
Eligibility
- Min Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
- Puerto Rico
Study Locations
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