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Bronchial AsthmaNCT04958616

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

An observational study of Bronchial Asthma, run by Mansoura University Children Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 18 years
Conditions the study is for
Bronchial Asthma
What is being tested?
Skin prick test.
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Feb 2018to 1 Mar 2019
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 7 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Amr Sarhan

    Al Mansurah, None Selected, 35516

Other trials in Egypt

About this study

Official title: Association Between House Dust Mites Sensitization and Level of Asthma Control and Severity in Children Attending Mansoura University Children's Hospital.

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.

Read the detailed description

This is an observational, case control study. The study was carried out in Allergy, Clinical Immunology and pediatric pulmonology Unit; at Mansoura University Children Unit during the years 2018-2019. The study included 60 children above 6 years with atopic asthma. They were 42 males and 18 females, their age ranged from 8-17 years. Bronchial asthma diagnosis was based on clinical manifestations and spirometry results. Atopy was defined as presence of symptoms of atopic dermatitis, allergic rhino conjunctivitis, or food allergy, it was confirmed when asthmatic children fulfilled one of the following criteria: higher serum level of total IgE (more than 32IU/ml), eosinophilia (differential count more than 5% or absolute count more than 450/µl) or positive skin prick test (3 mm greater than control).

Asthmatic children were maintained on controller therapy for at least 6 months. They were classified according to skin prick test results into two groups:

  • Group1: It included 30 atopic asthmatic children, who were sensitive to one of the two HDM (D pteronyssinus or D farina).
  • Group2: It included 30 atopic asthmatic children who were not sensitive to HDM allergy.
  • Sampling Samples were convenient and patients were enrolled in the study by consecutive manner. history taking
  • Personal and demographic data e.g. age, sex and residence.
  • Asthma symptoms; cough, wheeze, as well as exercise-induced asthma.
  • Symptoms of other atopic diseases in the child including allergic march.
  • Based on frequency of each symptom, assessment of asthma control was done according to GINA 2017.

Pulmonary Function Test (Spirometry) Forced expiratory volume in 1 second FEV1%; forced vital capacity (FVC %); FEV1/FVC ratio and forced expiratory flow rate from 25% to 75% of vital capacity (FEF25-75%) were measured by spirometry (Master Screen pediatrics). The highest reading of three successive measurements was taken. Reference values were computed according to the recommendations of the American Thoracic Society standards of acceptability and reproducibility in subjects above the age of 6 years who need cooperation for forced respiratory maneuver.

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. 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).

3- Eosinophil count Blood sample was collected in EDTA tube. Total leucocytic count and eosinophilia % were determined by automated cell counter [11].

4- Serum IgE Blood samples were collected into tubes with ethylene tetr-acetic acid (EDTA). After incubation at room temperature for 20 minutes, tubes were centrifuged for 15 minute at 2500 revolutions per minute (rpm). Supernatant levels of IgE were determined by the ELISA technique [12].

Assessment level of asthma severity Classification of asthma according to disease severity is defined level (mild, moderate, severe) according to treatment steps when the patient has been maintained on regular controller therapy for several months. 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 [2].

  1. Assessment level of asthma control based on asthma control score according to GINA guideline defined as controlled, partially controlled and well controlled .

Statistical analysis

Data were fed to the computer and analyzed using IBM SPSS Corp. Released 2013. IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp. The following tests were used:

Qualitative data: Chi-Square test for comparison of 2 or more groups. Monte Carlo test as correction for Chi-Square test when more than 25% of cells have count less than 5 in tables (>2*2).

Being tested
Skin prick test.
Keywords
Asthma severity, House dust mites.
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Skin prick test.Diagnostic test

    Also called pulmonary function tests ,spirometry.

    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)

Study groups in NCT04958616
Study groupRoleWhat they receive
Patients sensitive to HDMClassification 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)
Receives: 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).
Receives: Diagnostic Test: Skin prick test.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2021
  2. Study start1 Feb 2018
  3. Primary completion1 Feb 2019
  4. Study completion1 Mar 2019

Resources

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-control
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04958616
Sponsor's protocol ID
Ms.18.07.201
Status last verified
Jul 2021
First submitted
29 Jun 2021
Last updated
12 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchial Asthma, run by Mansoura University Children Hospital at 1 site in Egypt.

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 3 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 Jul 2021. 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 Egypt. 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?

Assessment of asthma severity and level of control. (time frame: 1 year). 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 12 Jul 2021.

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