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

Not Applicable

Terminated

• Conditions: Occupational Asthma
• Interventions: Other: standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)

• Registration Number: NCT01783873
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-02-01
• Study First Posted: 2013-02-05
• Status Verified: 2019-08
• Primary Completion: 2019-12-12
• Study Completion: 2019-12-12
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)	-
flour allergen extract or quaternary ammonium compound	standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)	-

Primary Outcome Measures

Name	Time	Method
Assessment of cellular inflammation in peripheral blood and induced sputum	33 months	Before and after bronchial challenge: assessment of cellular inflammation in peripheral blood and induced sputum, exhaled NO; assessment of peripheral T lymphocyte phenotype.

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg,, France