This study is currently not recruiting participants.

A Phase 3 Randomized Double-Blind Placebo-Controlled Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas aeruginosa I

Study on Safety and Effectiveness of Investigational Medication for CF with Chronic PA Infection

Not Recruiting
6 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to see how safe and effective AZLI (the study drug) alternating with TIS compares to placebo alternating with TIS to treat CF patients with chronic PA infection.

Detailed description of study

The purpose of this study is to see how safe and effective AZLI (the study drug) alternating with TIS compares to placebo alternating with TIS to treat CF patients with chronic PA infection.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cystic Fibrosis
  • Age: 6 years - 100 years
  • Gender: All

This study investigates the safety and effectiveness of an investigational medication alternating with another treatment in comparison to a placebo for treating patients with cystic fibrosis (CF) who have a chronic Pseudomonas aeruginosa (PA) infection. Cystic fibrosis is a genetic condition that affects the lungs and digestive system, while Pseudomonas aeruginosa is a type of bacteria that can cause lung infections.

Participants will receive either the investigational medication or a placebo, both alternating with another treatment. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will monitor the safety and effectiveness of these treatments in managing CF with chronic PA infection.

  • Who can participate: Participants must meet specific age criteria and other key eligibility factors, which will be detailed during the screening process.
  • Study details: Participants will take the investigational medication or placebo in alternating cycles with another treatment.
Updated on 19 Feb 2024. Study ID: 1210009687

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