- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03607396
Study for Evaluating the Real Use of Inhaled Aztreonam Lysine in Patients With Cystic Fibrosis (REALIZA-FQ)
July 23, 2018 updated by: Hospital Universitari Vall d'Hebron Research Institute
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
- Name: Olga SanchezMaroto
- Phone Number: 934893000
- Email: olga.sanchez-maroto@vhir.org
Study Locations
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-
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Madrid, Spain
- Recruiting
- Hospital 12 de Octubre
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Contact:
- Carmen Luna, MD
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Principal Investigator:
- Carmen Luna, MD
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Catalunya
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Barcelona, Catalunya, Spain, 08035
- Recruiting
- Hospital Vall d'Hebron
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Contact:
- Aurora Fernandez
- Phone Number: 934893000
- Email: aufernan@vhebron.net
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Principal Investigator:
- Aurora Fernandez
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Principal Investigator:
- Silvia Gartner, MD
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Principal Investigator:
- Antonio Alvárez, MD
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Comunidad Valenciana
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Valencia, Comunidad Valenciana, Spain
- Not yet recruiting
- Hospital la Fe
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Contact:
- Emilio Monte
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Principal Investigator:
- Emilio Monte
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-
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.
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFP-AZT-2017-01
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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-
Arrowhead PharmaceuticalsTerminatedCystic Fibrosis, PulmonaryAustralia, New Zealand
-
AzurRx SASCompletedCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of PancreasTurkey, Hungary
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University Hospital, BordeauxCompleted
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Mack Biotech, Corp.Completed