NCT01937494

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

August 29, 2013

Last Update Submit

February 20, 2015

Conditions

AsthmaBronchial Hyperresponsiveness

Keywords

asthmabronchial hyperresponsivenesshistamine challenge testspirometry

Outcome Measures

Primary Outcomes (1)

  • spirometric values in patients exposed passively to histamine during BHR challenge

    1 hour

Study Arms (1)

asthma patients

EXPERIMENTAL

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

Drug: histamine-benzylic alcohol (magistral preparation)

Interventions

histamine-benzylic alcohol (magistral preparation)DRUG

passive exposure to histamine during a bronchial hyperresponsiveness challenge

asthma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • other active respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

service de pneumologie, CHU St Pierre

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

AsthmaBronchial Hyperreactivity

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Marie Bruyneel, MD

    CHU ST Pierre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CCA, pneumologie

Study Record Dates

First Submitted

August 29, 2013

First Posted

September 9, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

February 23, 2015

Record last verified: 2015-02

Locations

BE(1)