Study for Evaluating the Real Use of Inhaled Aztreonam Lysine in Patients With Cystic Fibrosis

• Conditions: Cystic Fibrosis

• Registration Number: NCT03607396
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

The aim of this observational trial is to evaluate the pulmonary function in cystic fibrosis patients that have been treated with inhaled aztreonam lysine comparing the previous 12 months before the treatment and the forward 12 months after initiating the treatment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-07
• Study Start: 2018-07-01
• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-07-23
• Last Update Submitted: 2018-07-23
• Study First Posted: 2018-07-31
• Last Update Posted: 2018-07-31
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Patients above 6 years old that have been treated with Aztreonam Lysine (AZLI) at any time within 12 months before starting the treatment
• Diagnosis of Cystic Fibrosis confirmed
• Chronic infection by Pseudomonas aeruginosa
• Patients can be treated with any inhaled antibiotic before or after AZLI treatment
• Patients have to have the following FEV1 measures: 12 months before starting AZLI; at AZLI initiation; 12 months after starting AZLI
• For lung transplant patiens, only data before the transplant will be collected.

Exclusion Criteria

• Non applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FEV1	12 months	Forced expiratory volume in one second (FEV1) measured during pulmonary function test.

Trial Locations

Locations (3)

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Catalunya, Spain

Hospital La Fe; 🇪🇸 Valencia, Comunidad Valenciana, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain