NCT02342951

Brief Summary

The purpose of this study is to determine the efficacy of a non invasive method of detecting the pulmonary disease in order to initiate treatment against cystic fibrosis as soon as possible. Moreover this screening procedure permits to note the improvement following the treatment and to choose the optimal treatment in term of efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

April 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

5 years

First QC Date

August 7, 2014

Last Update Submit

October 18, 2019

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis,lung clearance index,pulmonary function

Outcome Measures

Primary Outcomes (1)

  • measure of nitrogen washout and Brody 2 score

    Month 0

Secondary Outcomes (2)

  • measure of FEV (Correlation between the evolution of LCI and respiratory function endpoints and CT)

    2 years

  • measure of FEV (Evaluation of LCI predictive value for respiratory function in preschool children)

    2 years

Study Arms (1)

LCI

OTHER

Measure of lung clearance index

Other: Lung clearance index determination

Interventions

Lung clearance index determinationOTHER

Lung clearance index determination

LCI

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with typical cystic fibrosis (sweat chloride level \>60 mEq/l) followed in reference centre participating to the study
  • From 3 to 6 years old
  • Children with a planned annual assessment that required thoracic computed tomography and lung function test
  • Children with informed and non opposed parents

You may not qualify if:

  • Children with atypical cystic fibrosis
  • Children with bronchial exacerbation dating less than 2 weeks
  • Children with severe associated disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

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

Study Officials

  • Muriel Le Bourgeois, MD

    Service de pneumologie pédiatrique, Hôpital Necker-Enfants Malades Assistance Publique Hôpitaux de Paris 75015 Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2014

First Posted

January 21, 2015

Study Start

April 1, 2014

Primary Completion

April 1, 2019

Study Completion

July 1, 2019

Last Updated

October 21, 2019

Record last verified: 2019-10

Locations

FR(1)