NCT02883920

Brief Summary

Work related asthma and rhinitis are frequent diseases with a significant morbidity and a social and economic impact. Farmers are highly exposed to various inhaled agents such as organic or inorganic dust, endotoxin, micro-organisms, pollen, mites, moulds, animal danders and pesticides, inducing rhinitis, asthma, chronic bronchitis, hypersensitivity pneumonitis and organic dust toxic syndrome. Work related respiratory symptoms are frequent in crop farmers. Allergic rhinitis and respiratory symptoms in fruit farmers are mainly related to pollen allergy, especially gramineae pollen. They can also be related to the use of pesticides or exposure to mites .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 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

Study Start

First participant enrolled

January 1, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

3.9 years

First QC Date

August 25, 2016

Last Update Submit

August 29, 2016

Conditions

Respiratory Symptoms

Outcome Measures

Primary Outcomes (1)

  • Sensitization

    A positive skin prick test was defined as the presence of a mean wheal diameter of 3 mm or more than the negative control. Sensitization was defined by a positive skin reaction to one or more allergens

    Day 0

Study Arms (1)

workers of Champagne vineyard

Other: Allergy and respiratory functional tests

Interventions

Allergy and respiratory functional testsOTHER
workers of Champagne vineyard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

workers of Champagne vineyard.

You may qualify if:

  • workers of Champagne vineyard
  • aged \> 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, France, 51092, France

Location

Related Publications (1)

  • Perotin JM, Barbe C, Nguyen KL, Fontaine JF, Gabignon Y, Nardi J, Launois C, Lebargy F, Lavaud F, Deslee G. Work-related respiratory symptoms in Champagne vineyard workers. Eur Ann Allergy Clin Immunol. 2015 Sep;47(5):140-4.

    PMID: 26356997BACKGROUND

MeSH Terms

Conditions

Signs and Symptoms, Respiratory

Interventions

Sensitivity and Specificity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesStatistics as TopicMathematical ConceptsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

August 30, 2016

Study Start

January 1, 2007

Primary Completion

December 1, 2010

Study Completion

January 1, 2012

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations

FR(1)