AllergyNCT02730520
Impact of Age on the Prevalence of Allergic Sensitization
An observational study of Allergy, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Worldwide, respiratory diseases have a significant impact on morbidity and mortality of individuals.Tobacco, lifestyle and certain allergens such as dust mites play an important role in the prevalence and morbidity of these diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergy
- What is being tested?
- Retrospective analysis of patient files
- How many people
- 1,400 participants
- Where
- 1 siteBelgium
- Study dates
- May 2016to Sep 2016
- Phase
- Observational
- 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
Study population: Patients followed within the Immuno-Allergology Service of the CHU Brugmann Hospital, who received an allergy assessment between 01/01/2015 and 31/12/2015.
Who may be able to join
- All patients followed within the Immuno-Allergology Service of the CHU Brugmann Hospital
- Who received an allergy assessment between 01/01/2015 and 31/12/2015. The allergens tested include: dermatophagoides pteronyssinus (DEPT), dermatophagoides farinae (DPF), blomia, cat, dog, cockroach, orchardgrass, timothy grass, alder, hazel,birch, olive tree, cypress, ash, latex, aspergillus, alternaria, cladosporium, peanut, hazel.
Who cannot join
- Negative histamine patients
Trial locations and contacts
1 site in 1 country.
About this study
Worldwide, respiratory diseases have a significant impact on morbidity and mortality of individuals.Tobacco, lifestyle and certain allergens such as dust mites play an important role in the prevalence and morbidity of these diseases. Scientific literature indicates that sensitization to allergens and respiratory diseases (asthma, rhinitis, chronic obstructive pulmonary disease) are closely linked. Moreover, smoking has an effect on allergen sensitivity.
To make a diagnosis of allergic sensitization, skin tests are performed in the patient. One of the methods used is the technique of "prick test". In practice, a drop of purified allergen extract is placed on the patient's skin (arms or back). A little dosis of the product is then injected in the epidermis. If fifteen minutes later, there is an edematous reaction, its diameter is measured in millimeters. From 4 mm, it is considered that the patient is sensitized to the tested foods or allergens.This technique is painless and convenient to patients of all ages, including newborns or conversely very aged patients.
Read more
This is a retrospective study based on the encoding and statistical analysis of data collected in patients followed within the Immuno-Allergology Service of the CHU Brugmann Hospital, who received an allergy assessment between 01/01/2015 and 31/12/2015. The allergens tested include: dermatophagoides pteronyssinus (DEPT), dermatophagoides farinae (DPF), blomia, cat, dog, cockroach, orchardgrass, timothy grass, alder, hazel,birch, olive tree, cypress, ash, latex, aspergillus, alternaria, cladosporium, peanut, hazel.
At least 1400 files will be analyzed.
Patients will be distributed in six age groups.The results of the allergen skin tests will be encoded as the edema diameter. The allergenicity score (mean of the skin reactivities for each allergen) will be compared between each age groups. The impact of tabagism, gender, BMI and residential area on the allergic reactivity will also be assessed in the overall population and within each age group.
The main objective is to evaluate the effect of age on the skin test positivity. The secondary objective is to highlight the environmental factors that have an impact on allergic diseases.
- Conditions
- Allergy
- Being tested
- Retrospective analysis of patient files
- Keywords
- respiratory disease, allergen sensitization, aging, skin tests, air allergens
- Medical subject headings
- Hypersensitivity, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective analysis of patient filesOther
The results of the allergen skin tests will be encoded as the edema diameter. The allergenicity score (mean of the skin reactivities for each allergen) will be compared between each age groups. The impact of tabagism, gender, BMI and residential area on the allergic reactivity will also be assessed in the overall population and within each age group.
| Study group | Role | What they receive |
|---|---|---|
| Immuno-allergology patients | Patients followed within the Immuno-Allergology Service of the CHU Brugmann Hospital, who received an allergy assessment between 01/01/2015 and 31/12/2015. At least 1400 dermis will be analyzed. The allergens tested include: dermatophagoides pteronyssinus (DEPT), dermatophagoides farinae (DPF), blomia, cat, dog, cockroach, orchardgrass, timothy grass, alder, hazel,birch, olive tree, cypress, ash, latex, aspergillus, alternaria, cladosporium, peanut, hazel. Receives: Other: Retrospective analysis of patient files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergenicity score
Mean of the skin reactivities for each allergen. The results of the allergen skin tests are encoded as the edema diameter. Scores will be compared between the different age groups.
Measured: one year (01/01/2015 to 31/12/2015)
Secondary outcomes (4)
Smoking status
Effect of the smoking/non smoking status on the allergic reactivity, analysed in the hole group and in the different age groups.
Measured: one year (01/01/2015 to 31/12/2015)
Geographic localisation
Effect of the area of residence on the allergic reactivity, analysed in the hole group and in the different age groups.
Measured: one year (01/01/2015 to 31/12/2015)
Sex
Gender effect on the allergic reactivity, analysed in the hole group and in the different age groups.
Measured: one year (01/01/2015 to 31/12/2015)
Body Mass Index
Effect of the body mass index on the allergic reactivity, analysed in the hole group and in the different age groups.
Measured: one year (01/01/2015 to 31/12/2015)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Michel, Brugmann University Hospital
- Investigators
- Olivier Michel, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730520
- Sponsor's protocol ID
- CHUB-Age-Allergy
- Status last verified
- Sep 2016
- First submitted
- 1 Apr 2016
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bauchau V, Durham SR. Epidemiological characterization of the intermittent and persistent types of allergic rhinitis. Allergy. 2005 Mar;60(3):350-3. doi: 10.1111/j.1398-9995.2005.00751.x.
PubMed 15679721
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Age on the Prevalence of Allergic Sensitization
- ClinicalTrials.gov ID
- NCT02730520
- Acronym / sponsor ID
- CHUB-Age-Allergy
- Conditions
- Allergy
- Keywords
- respiratory disease, allergen sensitization, aging, skin tests, air allergens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Apr 2016 (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.
Worldwide, respiratory diseases have a significant impact on morbidity and mortality of individuals.Tobacco, lifestyle and certain allergens such as dust mites play an important role in the prevalence and morbidity of these diseases. Scientific literature indicates that sensitization to allergens and respiratory diseases (asthma, rhinitis, chronic obstructive pulmonary disease) are closely linked. Moreover, smoking has an effect on allergen sensitivity.
To make a diagnosis of allergic sensitization, skin tests are performed in the patient. One of the methods used is the technique of "prick test". In practice, a drop of purified allergen extract is placed on the patient's skin (arms or back). A little dosis of the product is then injected in the epidermis. If fifteen minutes later, there is an edematous reaction, its diameter is measured in millimeters. From 4 mm, it is considered that the patient is sensitized to the tested foods or allergens.This technique is painless and convenient to patients of all ages, including newborns or conversely very aged patients.
This is a retrospective study based on the encoding and statistical analysis of data collected in patients followed within the Immuno-Allergology Service of the CHU Brugmann Hospital, who received an allergy assessment between 01/01/2015 and 31/12/2015. The allergens tested include: dermatophagoides pteronyssinus (DEPT), dermatophagoides farinae (DPF), blomia, cat, dog, cockroach, orchardgrass, timothy grass, alder, hazel,birch, olive tree, cypress, ash, latex, aspergillus, alternaria, cladosporium, peanut, hazel.
At least 1400 files will be analyzed.
Patients will be distributed in six age groups.The results of the allergen skin tests will be encoded as the edema diameter. The allergenicity score (mean of the skin reactivities for each allergen) will be compared between each age groups. The impact of tabagism, gender, BMI and residential area on the allergic reactivity will also be assessed in the overall population and within each age group.
The main objective is to evaluate the effect of age on the skin test positivity. The secondary objective is to highlight the environmental factors that have an impact on allergic diseases.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immuno-allergology patients | – | Other: Retrospective analysis of patient filesPatients followed within the Immuno-Allergology Service of the CHU Brugmann Hospital, who received an allergy assessment between 01/01/2015 and 31/12/2015. At least 1400 dermis will be analyzed. The allergens tested include: dermatophagoides pteronyssinus (DEPT), dermatophagoides farinae (DPF), blomia, cat, dog, cockroach, orchardgrass, timothy grass, alder, hazel,birch, olive tree, cypress, ash, latex, aspergillus, alternaria, cladosporium, peanut, hazel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed within the Immuno-Allergology Service of the CHU Brugmann Hospital, who received an allergy assessment between 01/01/2015 and 31/12/2015.
Key inclusion criteria (2 listed)
- All patients followed within the Immuno-Allergology Service of the CHU Brugmann Hospital
- Who received an allergy assessment between 01/01/2015 and 31/12/2015. The allergens tested include: dermatophagoides pteronyssinus (DEPT), dermatophagoides farinae (DPF), blomia, cat, dog, cockroach, orchardgrass, timothy grass, alder, hazel,birch, olive tree, cypress, ash, latex, aspergillus, alternaria, cladosporium, peanut, hazel.
Key exclusion criteria (1 listed)
- Negative histamine patients
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 |
|---|---|---|
| Retrospective analysis of patient filesThe results of the allergen skin tests will be encoded as the edema diameter. The allergenicity score (mean of the skin reactivities for each allergen) will be compared between each age groups. The impact of tabagism, gender, BMI and residential area on the allergic reactivity will also be assessed in the overall population and within each age group. | Other | Immuno-allergology patients |
Primary outcome
Allergenicity score
Time frame: one year (01/01/2015 to 31/12/2015)
Mean of the skin reactivities for each allergen. The results of the allergen skin tests are encoded as the edema diameter. Scores will be compared between the different age groups.
4 secondary outcomes
Smoking status
Time frame: one year (01/01/2015 to 31/12/2015)
Geographic localisation
Time frame: one year (01/01/2015 to 31/12/2015)
Sex
Time frame: one year (01/01/2015 to 31/12/2015)
Body Mass Index
Time frame: one year (01/01/2015 to 31/12/2015)
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 12 Sep 2016.
- Background: PubMed 15679721Bauchau V, Durham SR. Epidemiological characterization of the intermittent and persistent types of allergic rhinitis. Allergy. 2005 Mar;60(3):350-3. doi: 10.1111/j.1398-9995.2005.00751.x.
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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.
Olivier Michel, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy, run by Brugmann University Hospital 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 2 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 12 Sep 2016. 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?
Allergenicity score (time frame: one year (01/01/2015 to 31/12/2015)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02730520, which also lists 1 linked publication.
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 12 Sep 2016.