NCT02730520

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

April 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

April 1, 2016

Last Update Submit

September 9, 2016

Conditions

Keywords

respiratory diseaseallergen sensitizationagingskin testsair allergens

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year (01/01/2015 to 31/12/2015)

Secondary Outcomes (4)

  • Smoking status

    one year (01/01/2015 to 31/12/2015)

  • Geographic localisation

    one year (01/01/2015 to 31/12/2015)

  • Sex

    one year (01/01/2015 to 31/12/2015)

  • Body Mass Index

    one year (01/01/2015 to 31/12/2015)

Study Arms (1)

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.

Other: Retrospective analysis of patient files

Interventions

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.

Immuno-allergology patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Negative histamine patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 15679721BACKGROUND

MeSH Terms

Conditions

HypersensitivityRespiration Disorders

Condition Hierarchy (Ancestors)

Immune System DiseasesRespiratory Tract Diseases

Study Officials

  • Olivier Michel, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 6, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 12, 2016

Record last verified: 2016-09

Locations