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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

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01783873
First received: January 28, 2013
Last updated: February 1, 2013
Last verified: January 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Assessment of cellular inflammation in peripheral blood and induced sputum [ Time Frame: 33 months ] [ Designated as safety issue: No ]
    Before and after bronchial challenge: assessment of cellular inflammation in peripheral blood and induced sputum, exhaled NO; assessment of peripheral T lymphocyte phenotype.


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01783873     History of Changes
Other Study ID Numbers: 4707
Study First Received: January 28, 2013
Last Updated: February 1, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 21, 2013