NCT03607396

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

July 23, 2018

Last Update Submit

July 23, 2018

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • FEV1

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

    12 months

Eligibility Criteria

Age6 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cystic fibrosis patients colonized by Pseudomonas aeruginosa

You may qualify if:

  • 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.

You may not qualify if:

  • Non applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

RECRUITING

Hospital La Fe

Valencia, Valencia, Spain

NOT YET RECRUITING

Hospital 12 de Octubre

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Central Study Contacts

Olga SanchezMaroto

CONTACT

934893000olga.sanchez-maroto@vhir.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2018

First Posted

July 31, 2018

Study Start

July 1, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 31, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)