Bronchial Hyperreactivity During Histamine Passive Exposure

NCT ID: NCT01937494

Last Updated: 2015-02-23

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

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-05-31

Brief Summary

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Bronchial hyperresponsiveness consists in excessive response to bronchial stimuli.Bronchial challenge test is used to confirm/exclude asthma (metacholine or histamine).Protection are used to avoid passive exposure of the technicians performing the test, despite the absence of evidence that they could develop a bronchoconstriction even if they suffer from BHR.The purpose of the study is to determine if patients with a high level of bronchial hyperreactivity and exposed passively to histamine during a bronchial challenge, are developing a bronchoconstriction, when placed in the same conditions that the technicians performing these tests.

Detailed Description

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Bronchial hyperresponsiveness (BHR) consists in excessive response to bronchial stimuli.Bronchial challenge test is used to confirm/exclude asthma.BHR is also present in other diseases such as allergic rhinitis, Chronic Obstructive pulmonary disease,heart failure..

Thes test is performed with metacholine or histamine with spirometric documented response to incremental doses.Protection are used to avoid passive exposure of the technicians performing the test, despite the absence of evidence that they could develop a bronchoconstriction if they suffer from BHR.

The purpose of the study is to determine if patients, newly diagnosed with a high level of bronchial hyperreactivity and exposed passively to histamine during a bronchial challenge, are reacting to histamine when placed in the same conditions that the technicians performing these tests.

Conditions

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Asthma Bronchial Hyperresponsiveness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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asthma patients

patients who show a positive response at the first dos of histamine challenge test will be enrolled

Group Type EXPERIMENTAL

histamine-benzylic alcohol (magistral preparation)

Intervention Type DRUG

passive exposure to histamine during a bronchial hyperresponsiveness challenge

Interventions

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histamine-benzylic alcohol (magistral preparation)

passive exposure to histamine during a bronchial hyperresponsiveness challenge

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients with positive histamine challenge test (first dose)

Exclusion Criteria

* other active respiratory disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role lead

Responsible Party

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Marie Bruyneel

CCA, pneumologie

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie Bruyneel, MD

Role: PRINCIPAL_INVESTIGATOR

CHU ST Pierre

Locations

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service de pneumologie, CHU St Pierre

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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AK/13-03-34/4235

Identifier Type: -

Identifier Source: org_study_id

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