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Bronchial Hyperreactivity During Histamine Passive Exposure

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ClinicalTrials.gov Identifier: NCT01937494
Recruitment Status : Completed
First Posted : September 9, 2013
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre

Tracking Information
First Submitted Date  ICMJE August 29, 2013
First Posted Date  ICMJE September 9, 2013
Last Update Posted Date February 23, 2015
Study Start Date  ICMJE May 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
spirometric values in patients exposed passively to histamine during BHR challenge [ Time Frame: 1 hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01937494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bronchial Hyperreactivity During Histamine Passive Exposure
Official Title  ICMJE Are Technicians Showing Bronchial Hyperreactivity Able to Safely Perform Bronchial Provocation Tests?
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Asthma
  • Bronchial Hyperresponsiveness
Intervention  ICMJE Drug: histamine-benzylic alcohol (magistral preparation)
passive exposure to histamine during a bronchial hyperresponsiveness challenge
Study Arms  ICMJE Experimental: asthma patients
patients who show a positive response at the first dos of histamine challenge test will be enrolled
Intervention: Drug: histamine-benzylic alcohol (magistral preparation)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2015)
13
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2013)
10
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • other active respiratory disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01937494
Other Study ID Numbers  ICMJE AK/13-03-34/4235
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
Study Sponsor  ICMJE Centre Hospitalier Universitaire Saint Pierre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie Bruyneel, MD CHU ST Pierre
PRS Account Centre Hospitalier Universitaire Saint Pierre
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP