NCT01055847

Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection

A Blinded, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam for Inhalation (AI) in Cystic Fibrosis Patient With Lung Disease Due to P. Aeruginosa Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is multicenter placebo-controlled study evaluating the safety and efficacy of a 14-day treatment of AI at two dosage levels as compared to placebo, given twice daily, in CF patients with P. aeruginosa lung infection, delivered by the eFlow investigational nebulizer.

Conditions

• Cystic Fibrosis
• CF
• Lung Infection
• Pseudomonas Aeruginosa

Interventions

Type	Name	Description
DRUG	Aztreonam for Inhalation (AI)	Aztreonam for Inhalation
DRUG	Placebo	Saline Placebo

Timeline

• Start date: 2003-06-01
• Primary completion: 2004-08-01
• Completion: 2004-09-01
• First posted: 2010-01-26
• Last updated: 2010-01-26

Locations

20 sites across 1 country: United States