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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03607396

Acronym

REALIZA-FQ

Enrollment

Registered

2018-07-31

Start date

2018-07-01

Completion date

2019-07-01

Last updated

2018-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
FEV1	12 months	Forced expiratory volume in one second (FEV1) measured during pulmonary function test.

Countries

Spain

Contacts

Primary ContactOlga SanchezMaroto

olga.sanchez-maroto@vhir.org934893000

Outcome results