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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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ClinicalTrials.gov Identifier: NCT01783873
Recruitment Status : Recruiting
First Posted : February 5, 2013
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Occupational Asthma Other: standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
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 Start Date : September 2012
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Placebo Comparator: Placebo 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.

Active Comparator: flour allergen extract or quaternary ammonium compound 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.




Primary Outcome Measures :
  1. Assessment of cellular inflammation in peripheral blood and induced sputum [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783873


Contacts
Contact: Frédéric De BLAY, MD 03.69.55.06.39 ext 0033 frederic.deblay@chru-strasbourg.fr

Locations
France
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg,, France, 67091
Contact: Cindy BARNIG, MD    03.69.55.11.46 ext 0033    Cindy.barnig@chru-strasbourg.fr   
Sub-Investigator: Jean-Marie RENAUDIN, MD         
Sub-Investigator: Cindy BARNIG, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Frédéric De BLAY, MD University Hospital, Strasbourg, France

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01783873     History of Changes
Other Study ID Numbers: 4707
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Asthma
Asthma, Occupational
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Occupational Diseases