Retrospective Observational Study to Compare Cystic Fibro... | NCT01651455

Studies
Retrospective Observational Study to Compare Cystic Fibrosis Patients in Two Decades Before and After 2000

NCT01651455

Sponsor

Chiesi Farmaceutici S.p.A.

Status

Completed

Last Update Posted

Jul 31, 2013Estimated

Enrollment

92Actual

Phase

Not provided

Conditions

Cystic Fibrosis

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jul 25, 2012

First Submission Date that Met QC Criteria

Jul 26, 2012

First Posted Date

Jul 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2013

Last Update Posted Date

Jul 31, 2013Estimated

Name	Class
Medidata Solutions	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in terms of FEV1 maintenance from the age of 10 to 15 before and after 2000.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To describe the difference in terms of FEV1 decline between two cohorts of cystic fibrosis patients		5 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Baroukh Maurice Assael, Professor	U.O. Fibrosi Cistica Azienda Ospedaliera Verona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
U.O. Azienda Ospedaliera		Verona	Veneto	37126	Italy

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis
D011552	Pseudomonas Infections

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided