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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2019-12-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Occupational Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)

Intervention Type OTHER

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.

flour allergen extract or quaternary ammonium compound

Group Type ACTIVE_COMPARATOR

standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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%.