Back to resultsComparative Study of Pathophysiological Mechanisms and Bronchial Response in Occupational Asthma to Wheat Flour and Quaternary Ammonium Compounds During Standardized Bronchial Provocation Tests
Primary Purpose
Occupational Asthma
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)
Sponsored by
About this trial
This is an interventional other trial for Occupational Asthma
Eligibility Criteria
Inclusion Criteria:
For patients with occupational asthma to wheat flour:
- Clinical history,
- A positive skin test to wheat flour and / or specific IgE to wheat flour
For patients with occupational asthma to quaternary ammonium compounds:
-Clinical history,
For two types of asthma:
- Patients must have a worsening of bronchial hyperreactivity during work compared to a rest period assessed by a metacholine challenge
- FEV before challenge (nonspecific and specific) must be> 70%.
Exclusion Criteria:
Asthmas:
- no occupational asthma:
- secondary to clinically relevant sensitization to an allergen domestic
- aggravated at work.
Sites / Locations
- Hôpitaux Universitaires de Strasbourg
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
flour allergen extract or quaternary ammonium compound
Arm Description
Outcomes
Primary Outcome Measures
Assessment of cellular inflammation in peripheral blood and induced sputum
Before and after bronchial challenge: assessment of cellular inflammation in peripheral blood and induced sputum, exhaled NO; assessment of peripheral T lymphocyte phenotype.
Secondary Outcome Measures
Full Information
NCT ID
NCT01783873
First Posted
January 28, 2013
Last Updated
June 26, 2020
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT01783873
Brief Title
Comparative Study of Pathophysiological Mechanisms and Bronchial Response in Occupational Asthma to Wheat Flour and Quaternary Ammonium Compounds During Standardized Bronchial Provocation Tests
Official Title
Comparative Study of Pathophysiological Mechanisms and Bronchial Response in Occupational Asthma to Wheat Flour and Quaternary Ammonium Compounds During Standardized Bronchial Provocation Tests
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
recruitement difficulty
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
December 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Occupational asthma (OA) caused by high molecular weight (HMW) substances have been shown to induce predominantly an eosinophilic inflammation. In contrast, OA caused by low molecular weight (LMW) substances results in a neutrophilic inflammation. In addition, data regarding phenotype of lymphocytes in OA caused by HMW and LMW substances are scarce. The use of a new equipment will allow the realization of specific standardized bronchial challenges (BC) to occupational agents. Thus, we propose to study in more detail the cellular mechanisms involved during BC to HMW and LMW occupational agents in a double-blind placebo controlled study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occupational Asthma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
flour allergen extract or quaternary ammonium compound
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)
Intervention Description
At Visit 1: Patients are selected and they will receive a metacholine challenge test during and outside of work. After randomization, patients undergo a standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™) to either an wheat flour allergen extract or didecyldimethylammonium chloride or placebo. Each bronchial challenge test is followed by blood sampling at different time points and induced sputum. The immediate bronchial response and late bronchial response will be recorded.
Primary Outcome Measure Information:
Title
Assessment of cellular inflammation in peripheral blood and induced sputum
Description
Before and after bronchial challenge: assessment of cellular inflammation in peripheral blood and induced sputum, exhaled NO; assessment of peripheral T lymphocyte phenotype.
Time Frame
33 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
For patients with occupational asthma to wheat flour:
Clinical history,
A positive skin test to wheat flour and / or specific IgE to wheat flour
For patients with occupational asthma to quaternary ammonium compounds:
-Clinical history,
For two types of asthma:
Patients must have a worsening of bronchial hyperreactivity during work compared to a rest period assessed by a metacholine challenge
FEV before challenge (nonspecific and specific) must be> 70%.
Exclusion Criteria:
Asthmas:
no occupational asthma:
secondary to clinically relevant sensitization to an allergen domestic
aggravated at work.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric De BLAY, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg,
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparative Study of Pathophysiological Mechanisms and Bronchial Response in Occupational Asthma to Wheat Flour and Quaternary Ammonium Compounds During Standardized Bronchial Provocation Tests
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