Characterization of Phenotypes of Occupational Asthma | NCT03568305

Studies
Characterization of Phenotypes of Occupational Asthma

NCT03568305

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jun 27, 2018Actual

Enrollment

52Estimated

Phase

Not provided

Conditions

Occupational Asthma

Interventions

Not provided

Countries

France

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

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Jun 2019Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Jun 14, 2018

First Submission Date that Met QC Criteria

Jun 14, 2018

First Posted Date

Jun 26, 2018Actual

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

Jun 25, 2018

Last Update Posted Date

Jun 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 general objective of this multicenter, international study is to perform a multivariate descriptive analysis of a large population of well-defined subjects with sensitizer-induced OA ascertained by a positive SIC result in order to provide more information on the characteristics of this condition.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

52Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective study to perform a multi-varied descriptive analysis of a cohort of patients with occupational asthma confirmed by a specific inhalation test		The period from from January 1st, 2006 to December 31st, 2015 will be examined

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult Patient
Patient who performed a specific inhalation test with a positive result between January 2006 and December 2015.- Subject giving their consent for their participation
Patient agreeing to use his data for research purposes

Exclusion Criteria:

Patient objecting to the use of his data for research purposes
Subjects under safeguard of justice
Subject under guardianship or curatorship

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient who performed a specific inhalation test with a positive result between january 2006 and december 2015.- Subject giving their consent for their participation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Frédéric De Blay, MD, PhD	Contact	33.3.69.55.06.39		frederic.deblay@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Frédéric De Blay, MD, PhD	University Hospital, Strasbourg, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de pneumologie, d'allergologie et de pathologie de l'environnement	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D059366	Asthma, Occupational
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate

Browse Leaves

Not provided

Browse Branches

Not provided