Study for Evaluating the Real Use of Inhaled Aztreonam Lysine in Patients With Cystic Fibrosis (REALIZA-FQ)

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Cystic Fibrosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03607396

AFP-AZT-2017-01

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 6 to 65 years old

Volunteers: No Healthy Volunteers

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