AsthmaNCT01937494
Bronchial Hyperreactivity During Histamine Passive Exposure
A study testing histamine-benzylic alcohol (magistral preparation) in people with Asthma and Bronchial Hyperresponsiveness, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Bronchial Hyperresponsiveness
- What is being tested?
- histamine-benzylic alcohol (magistral preparation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- May 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients with positive histamine challenge test (first dose)
Who cannot join
- other active respiratory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Technicians Showing Bronchial Hyperreactivity Able to Safely Perform Bronchial Provocation Tests?
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.
Read the 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.
- Conditions
- Asthma, Bronchial Hyperresponsiveness
- Being tested
- histamine-benzylic alcohol (magistral preparation)
- Keywords
- asthma, bronchial hyperresponsiveness, histamine challenge test, spirometry
- Medical subject headings
- Asthma, Bronchial Hyperreactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
histamine-benzylic alcohol (magistral preparation)Drug
passive exposure to histamine during a bronchial hyperresponsiveness challenge
| Study group | Role | What they receive |
|---|---|---|
| asthma patients | Experimental | patients who show a positive response at the first dos of histamine challenge test will be enrolled Receives: Drug: histamine-benzylic alcohol (magistral preparation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
spirometric values in patients exposed passively to histamine during BHR challenge
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
- Investigators
- Marie Bruyneel, MD, Principal investigator, CHU ST Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937494
- Sponsor's protocol ID
- AK/13-03-34/4235
- Status last verified
- Feb 2015
- First submitted
- 29 Aug 2013
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Technicians Showing Bronchial Hyperreactivity Able to Safely Perform Bronchial Provocation Tests?
- ClinicalTrials.gov ID
- NCT01937494
- Acronym / sponsor ID
- AK/13-03-34/4235
- Conditions
- Asthma, Bronchial Hyperresponsiveness
- Keywords
- asthma, bronchial hyperresponsiveness, histamine challenge test, spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| asthma patients | Experimental | Drug: histamine-benzylic alcohol (magistral preparation)patients who show a positive response at the first dos of histamine challenge test will be enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients with positive histamine challenge test (first dose)
Key exclusion criteria (1 listed)
- other active respiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| histamine-benzylic alcohol (magistral preparation)passive exposure to histamine during a bronchial hyperresponsiveness challenge | Drug | asthma patients |
Primary outcome
spirometric values in patients exposed passively to histamine during BHR challenge
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Bruyneel, MD principal investigator
CHU ST Pierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing histamine-benzylic alcohol (magistral preparation) in people with Asthma and Bronchial Hyperresponsiveness, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spirometric values in patients exposed passively to histamine during BHR challenge (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.