search
Back to results

Bronchial Hyperreactivity During Histamine Passive Exposure

Primary Purpose

Asthma, Bronchial Hyperresponsiveness

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
histamine-benzylic alcohol (magistral preparation)
Sponsored by
Centre Hospitalier Universitaire Saint Pierre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring asthma, bronchial hyperresponsiveness, histamine challenge test, spirometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • other active respiratory disease

Sites / Locations

  • service de pneumologie, CHU St Pierre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

asthma patients

Arm Description

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

Outcomes

Primary Outcome Measures

spirometric values in patients exposed passively to histamine during BHR challenge

Secondary Outcome Measures

Full Information

First Posted
August 29, 2013
Last Updated
February 20, 2015
Sponsor
Centre Hospitalier Universitaire Saint Pierre
search

1. Study Identification

Unique Protocol Identification Number
NCT01937494
Brief Title
Bronchial Hyperreactivity During Histamine Passive Exposure
Official Title
Are Technicians Showing Bronchial Hyperreactivity Able to Safely Perform Bronchial Provocation Tests?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Bronchial Hyperresponsiveness
Keywords
asthma, bronchial hyperresponsiveness, histamine challenge test, spirometry

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
asthma patients
Arm Type
Experimental
Arm Description
patients who show a positive response at the first dos of histamine challenge test will be enrolled
Intervention Type
Drug
Intervention Name(s)
histamine-benzylic alcohol (magistral preparation)
Intervention Description
passive exposure to histamine during a bronchial hyperresponsiveness challenge
Primary Outcome Measure Information:
Title
spirometric values in patients exposed passively to histamine during BHR challenge
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients with positive histamine challenge test (first dose) Exclusion Criteria: other active respiratory disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Bruyneel, MD
Organizational Affiliation
CHU ST Pierre
Official's Role
Principal Investigator
Facility Information:
Facility Name
service de pneumologie, CHU St Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Bronchial Hyperreactivity During Histamine Passive Exposure

We'll reach out to this number within 24 hrs