- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01937494
Bronchial Hyperreactivity During Histamine Passive Exposure
Are Technicians Showing Bronchial Hyperreactivity Able to Safely Perform Bronchial Provocation Tests?
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, 1000
- service de pneumologie, CHU St Pierre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adult patients with positive histamine challenge test (first dose)
Exclusion Criteria:
- other active respiratory disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: asthma patients
patients who show a positive response at the first dos of histamine challenge test will be enrolled
|
passive exposure to histamine during a bronchial hyperresponsiveness challenge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
spirometric values in patients exposed passively to histamine during BHR challenge
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Bronchial Diseases
- Bronchial Hyperreactivity
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Histamine Agents
- Histamine Agonists
- Histamine
- Benzyl Alcohol
Other Study ID Numbers
- AK/13-03-34/4235
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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