Bronchial Hyperreactivity During Histamine Passive Exposure

Asthma Clinical Trial

Official title:

Are Technicians Showing Bronchial Hyperreactivity Able to Safely Perform Bronchial Provocation Tests?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937494
• Other study ID #: AK/13-03-34/4235
• Status: Completed
• Phase: N/A
• First received: August 29, 2013
• Last updated: February 20, 2015
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• other active respiratory disease

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma
• Bronchial Hyperreactivity
• Bronchial Hyperresponsiveness

Intervention

Drug:
• histamine-benzylic alcohol (magistral preparation)
passive exposure to histamine during a bronchial hyperresponsiveness challenge

Locations

Country	Name	City	State
Belgium	service de pneumologie, CHU St Pierre	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spirometric values in patients exposed passively to histamine during BHR challenge		1 hour	Yes