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

NCT01783873 | Terminated

• 1 other identifier: 4707
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Occupational Asthma

Outcome Measures

Primary Outcomes (1)

• Assessment of cellular inflammation in peripheral blood and induced sputum

  Before and after bronchial challenge: assessment of cellular inflammation in peripheral blood and induced sputum, exhaled NO; assessment of peripheral T lymphocyte phenotype.

  33 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

flour allergen extract or quaternary ammonium compound

ACTIVE COMPARATOR

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

Interventions

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

Placebo; flour allergen extract or quaternary ammonium compound

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%.

You may not qualify if:

• Asthmas:
• no occupational asthma:
• secondary to clinically relevant sensitization to an allergen domestic
• aggravated at work.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Asthma, Occupational

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Occupational Diseases

Study Officials

• Frédéric De BLAY, MD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: February 5, 2013
• Study Start: September 1, 2012
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: June 29, 2020

Record last verified: 2019-08

Locations

FR (1)