NCT01651455

Brief Summary

The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in 2 different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

6 months

First QC Date

July 25, 2012

Last Update Submit

July 30, 2013

Conditions

Cystic Fibrosis

Keywords

Cystic FibrosisPseudomonas Aeruginosa

Outcome Measures

Primary Outcomes (1)

  • To describe the difference in terms of FEV1 decline between two cohorts of cystic fibrosis patients

    5 years

Secondary Outcomes (3)

  • To identify clinical parameters or treatments correlated to FEV1 maintenance in two cohorts of cystic fibrosis patients

    5 years

  • To evaluate the number of patients with Pseudomonas Aeruginosa infection during observational period

    5 years

  • To describe length of time without Pseudomonas A. infection in non-colonized patients during observational period.

    5 years

Study Arms (2)

Cohort first decade

Patients born between 01/01/1979 and 12/31/1984

Cohort second decade

Patients born between 01/01/1991 and 12/31/1996

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients affected with Pseudomonas A. living in the N-E area of Italy.

You may qualify if:

  • Patients with Cystic Fibrosis diagnosed with neo-natal screening
  • Patients born between 01/01/1979 and 12/31/1984 (Cohort 1)and patients born between 01/01/1991 and 12/31/1996 (Cohort 2)
  • Patients with at least 2 FEV1 yearly measurements from the age of 10 to 15

You may not qualify if:

  • Patients with malignant tumor
  • Patients with meconium ileus
  • Patients with transplantation (pneumectomy or lobectomy)
  • Patients involved in any other clinical trial
  • Patients moved to another Clinical Center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.O. Azienda Ospedaliera

Verona, Veneto, 37126, Italy

Location

MeSH Terms

Conditions

Cystic FibrosisPseudomonas Infections

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Baroukh Maurice Assael, Professor

    U.O. Fibrosi Cistica Azienda Ospedaliera Verona

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 25, 2012

First Posted

July 27, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations

IT(1)