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.
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.
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].
- 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).
- Conditions
- Bronchial Asthma
- 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 group | Role | What they receive |
|---|---|---|
| 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) 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.
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.
- First posted12 Jul 2021
- Study start1 Feb 2018
- Primary completion1 Feb 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engy Osman Ahmed, Mansoura University Children Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between House Dust Mites Sensitization and Level of Asthma Control and Severity in Children Attending Mansoura University Children's Hospital.
- ClinicalTrials.gov ID
- NCT04958616
- Acronym / sponsor ID
- Ms.18.07.201
- Conditions
- Bronchial Asthma
- Keywords
- Asthma severity, House dust mites.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura University Children HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 12 Jul 2021 (actual)
- 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.
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.
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].
- 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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients sensitive to HDM | – | Diagnostic Test: Skin prick test.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) |
| Patients not sensitive to HDM allergy. | – | Diagnostic Test: Skin prick test.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). |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study was carried out in Allergy, Clinical Immunology and pediatric pulmonology Unit; at Mansoura University Children hospital.
Key inclusion criteria (2 listed)
- Age more than 6 years.
- Asthmatic children with history of atopy (atopic dermatitis, allergic rhinitis or food allergy).
Key exclusion criteria (3 listed)
- Other diseases which influence bronchial symptoms and/or lung function.
- Patients weren't compliant with asthma therapy.
- Refused the informed consent.
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 |
|---|---|---|
| Skin prick test.Also: 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) | Diagnostic test | Patients not sensitive to HDM allergy., Patients sensitive to HDM |
Primary outcome
Assessment of asthma severity and level of control.
Time frame: 1 year
. 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
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 Jul 2021.
- Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2020Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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.