House Dust Mites Sensitization and Level of Asthma Control and Severity in Children

NCT04958616 | Completed

• 1 other identifier: Ms.18.07.201
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this study we aimed to assess the clinical and laboratory profile of some Egyptian asthmatic children who are sensitized to house dust mites and determine the association of HDM sensitization and severity of asthma according to recent GINA guidelines.

Conditions

Bronchial Asthma

Keywords

Asthma severity; House dust mites.

Outcome Measures

Primary Outcomes (1)

• Assessment of asthma severity and level of control.

  . Patient maintained on step 2 treatments are often classified as having mild asthma. Those receive step 3-4 as moderate asthma and those prescribed step 4-5 as having moderate to severe asthma. Based on asthma control score according to GINA guideline defined as controlled, partially controlled and well controlled

  1 year

Study Arms (2)

Patients sensitive to HDM

Classification of asthma according to disease severity. Patient maintained on step 2 treatments are often classified as having mild asthma. Those receive step 3-4 as moderate asthma and those prescribed step 4-5 as having moderate to severe asthma. Assessment level of asthma control Based on asthma control score according to GINA guideline defined as controlled, partially controlled and well controlled.Skin prick test: for (Dermatophagoides pteronyssinus and Dermatophagoides Farina). Through the use of specific allergen extracts, positive and negative controls, then interpretation after 15-20 minutes of maneuver, a wheal ≥3 mm diameter is considered positive \[9\]. Before the test, we checked that the patient has not taken medications that might interfere with the test and antihistamines had stopped using before the skin prick test (2 days for the first generation and 7 days for the second generation)

Diagnostic Test: Skin prick test.

Patients not sensitive to HDM allergy.

Classification of asthma according to disease severity. Patient maintained on step 2 treatments are often classified as having mild asthma. Those receive step 3-4 as moderate asthma and those prescribed step 4-5 as having moderate to severe asthma. Assessment level of asthma control Based on asthma control score according to GINA guideline defined as controlled, partially controlled and well controlled .Skin prick test: for (Dermatophagoides pteronyssinus and Dermatophagoides Farina). Through the use of specific allergen extracts, positive and negative controls, then interpretation after 15-20 minutes of maneuver, a wheal ≥3 mm diameter is considered positive \[9\]. Before the test, we checked that the patient has not taken medications that might interfere with the test and antihistamines had stopped using before the skin prick test (2 days for the first generation and 7 days for the second generation).

Diagnostic Test: Skin prick test.

Interventions

Skin prick test. DIAGNOSTIC_TEST

Skin prick test: for (Dermatophagoides pteronyssinus and Dermatophagoides Farina). Through the use of specific allergen extracts, positive and negative controls, then interpretation after 15-20 minutes of maneuver, a wheal ≥3 mm diameter is considered positive \[9\]. Before the test, we checked that the patient has not taken medications that might interfere with the test and antihistamines had stopped using before the skin prick test (2 days for the first generation and 7 days for the second generation)

Also known as: pulmonary function tests ,spirometry.

Patients not sensitive to HDM allergy.; Patients sensitive to HDM

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study was carried out in Allergy, Clinical Immunology and pediatric pulmonology Unit; at Mansoura University Children hospital.

You may qualify if:

• Age more than 6 years.
• Asthmatic children with history of atopy (atopic dermatitis, allergic rhinitis or food allergy).

You may not qualify if:

• Other diseases which influence bronchial symptoms and/or lung function.
• Patients weren't compliant with asthma therapy.
• Refused the informed consent.

Sponsors & Collaborators

• Mansoura University Children Hospital: lead

Study Sites (1)

Amr Sarhan

Al Mansurah, None Selected, 35516, Egypt

Location

Related Links

• Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2020

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample was collected in EDTA tube for assessment of Eosinophil count and Serum IgE.

MeSH Terms

Conditions

Asthma

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of pediatrics, allergy and clinical immunology unit.

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 12, 2021
• Study Start: February 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)