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

U

University Hospital, Strasbourg, France

Status

Terminated

Conditions

Occupational Asthma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01783873
4707

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

35 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Other: standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)
flour allergen extract or quaternary ammonium compound
Active Comparator group
Treatment:
Other: standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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