Comparative Study of Pathophysiological Mechanisms and Bronchial Response in Occupational Asthma to Wheat Flour and Quaternary Ammonium Compounds During Standardized Bronchial Provocation Tests

Occupational Asthma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01783873
• Other study ID #: 4707
• Status: Terminated
• Phase: N/A
• Start date: September 2012
• Est. completion date: December 12, 2019

Study information

• Verified date: August 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: December 12, 2019
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma, Occupational
• Occupational Asthma

Intervention

Other:
• standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)
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.

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg,

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	33 months