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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Madrid, Spain
        • Recruiting
        • Hospital 12 de Octubre
        • Contact:
          • Carmen Luna, MD
        • Principal Investigator:
          • Carmen Luna, MD
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Recruiting
        • Hospital Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Aurora Fernandez
        • Principal Investigator:
          • Silvia Gartner, MD
        • Principal Investigator:
          • Antonio Alvárez, MD
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain
        • Not yet recruiting
        • Hospital la Fe
        • Contact:
          • Emilio Monte
        • Principal Investigator:
          • Emilio Monte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cystic fibrosis patients colonized by Pseudomonas aeruginosa

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

July 23, 2018

First Submitted That Met QC Criteria

July 23, 2018

First Posted (Actual)

July 31, 2018

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 23, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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