Clinical Trials Directory

Trials / Approved For Marketing

Approved For MarketingNCT00989807

Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis

Expanded Access for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression

Status
Approved For Marketing
Phase
Study type
Expanded Access
Enrollment
Sponsor
Gilead Sciences · Industry
Sex
All
Age
6 Years
Healthy volunteers

Summary

This program is to provide expanded access to aztreonam lysine for inhalation (AZLI) 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

Interventions

TypeNameDescription
DRUGAztreonam lysineOpen-label, expanded access for Aztreonam lysine for inhalation 75 mg three times daily

Timeline

First posted
2009-10-06
Last updated
2012-12-13

Locations

4 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT00989807. Inclusion in this directory is not an endorsement.