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NCT03607396 Clinical Trial

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

Cystic Fibrosis Clinical Trial

— REALIZA-FQ  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03607396
Other study ID # AFP-AZT-2017-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date July 1, 2019

Study information
Verified date July 2018
Source Hospital Universitari Vall d'Hebron Research Institute
Contact Olga SanchezMaroto
Phone 934893000
Email olga.sanchez-maroto@vhir.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 75
Est. completion date July 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group 6 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Spain Hospital Vall d'Hebron Barcelona Catalunya
Spain Hospital 12 de Octubre Madrid
Spain Hospital La Fe Valencia Comunidad Valenciana

Sponsors (2)
Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute Gilead Sciences

Country where clinical trial is conducted

Spain, 

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