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Status unknownNCT03607396REALIZA-FQUpdated Jul 31, 2018

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

An observational study in Cystic Fibrosis, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Status unknown at 3 sites in Spain. Open to participants aged 6 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-07-31.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
75
Ages
6 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cystic Fibrosis
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's planned enrollment of 75 is below the median of 85 across 482 observational studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cystic fibrosis patients colonized by Pseudomonas aeruginosa

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

Exclusion Criteria:

  • Non applicable
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
75 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. FEV1

    Forced expiratory volume in one second (FEV1) measured during pulmonary function test.

    Time frame: 12 months

07

Study locations

2 of 3 sites recruiting
  • Hospital Vall d'Hebron
    Barcelona, Catalunya 08035, Spain
    • Aurora Fernandez · Contact · aufernan@vhebron.net · 934893000
    • Aurora Fernandez · Principal investigator
    • Silvia Gartner, MD · Principal investigator
    • Antonio Alvárez, MD · Principal investigator
    Recruiting
  • Hospital La Fe
    Valencia, Comunidad Valenciana, Spain
    • Emilio Monte · Contact
    • Emilio Monte · Principal investigator
    Not yet recruiting
  • Hospital 12 de Octubre
    Madrid, Spain
    • Carmen Luna, MD · Contact
    • Carmen Luna, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03607396
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Gilead Sciences
Responsible party
Sponsor
First posted
Jul 31, 2018
Start date
Jul 1, 2018
Primary completion
Jul 1, 2019 (estimated)
Completion
Jul 1, 2019 (estimated)
Last update
Jul 31, 2018

Study contacts

Olga SanchezMaroto
Contact
olga.sanchez-maroto@vhir.org
934893000

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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