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Nghiên cứu tình trạng kiểm soát hen ở trẻ em hen phế quản có viêm mũi dị ứng (study of asthma control status in children with bronchial ashtma and allergic rhinitis) TT TIENG ANH

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MINISTRY OF EDUCATION AND TRAINING MINISTRY OF HEALTH HANOI MEDICAL UNIVERSITY NGUYEN TRAN NGOC HIEU STUDY OF ASTHMA CONTROL STATUS IN CHILDREN WITH BRONCHIAL ASTHMA AND ALLERGIC RHIN

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MINISTRY OF EDUCATION AND TRAINING MINISTRY OF HEALTH

HANOI MEDICAL UNIVERSITY

NGUYEN TRAN NGOC HIEU

STUDY OF ASTHMA CONTROL STATUS

IN CHILDREN WITH BRONCHIAL ASTHMA

AND ALLERGIC RHINITIS

Major: Pediatrics Code: 9720106

SUMARRY OF MEDICAL DOCTORAL THESIS

HANOI, 2022

The study was completed in:

HANOI MEDICAL UNIVERSITY

Sicence advisors:

1 A/Prof PhD Nguyen Thi Dieu Thuy

2 PhD Luong Cao Dong

Reviewer 1:

Reviewer 2:

Reviewer 3:

Thesis will be defended at The Commission for PhD thesis assessment

of Ha Noi Medical University

At …., date…., 2022

Thesis can be consulted at:

- National Library of Vietnam

- Library of Hanoi Medical University

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RELATED PUBLICATIONS

1 Nguyen Tran Ngoc Hieu, Nguyen Thi Dieu Thuy, Lương

Cao Don Applying of CARATkids questionaire for

assessment of asthma control in children with asthma

combined allergic rhinitis Journal of 108 - Clinical Medicine

and Pharmacy 2020; 15(3): 63-67

2 Nguyen Tran Ngoc Hieu, Luong Cao Dong and Nguyen Thi

Dieu Thuy Role of airway nitric oxide for asthma controls in

children with asthma combined allergic rhinitis Journal of

Medical Research Ha Noi Medical University 2020; 131(7):

141 - 147

3 H Nguyen - Tran - Ngoc, Th Nguyen - Thi - Dieu, D Luong -

Cao et al Study of asthma control status in children with

bronchial asthma and allergic rhinitis Journal of Functional

Ventilation and Pulmonology 2021; 37(12): 7-12

INTRODUCTION Bronchial asthma (BA) and allergic rhinitis (AR) are the most common chronic airway diseases in children For the purpose to help evaluate BA control in patients with co-morbidity of AR, the Control allergic rhinitis and asthma test for children (CARATkids) was developed to in 2010 for simultaneous control of both asthma and allergic rhinitis (BA-AR) in children This asthma control toolkit is relatively easy to use, but the results are quite subjective, depending on the awareness and care about the disease by the parents and the children with the disease

Both BA and AR are chronic inflammatory diseases of airways, and airway nitric oxide levels objectively reflect the airway inflammation Measuring Nasal Nitric Oxide (nNO) and Fractional Exhaed Nitric Oxide (FeNO) is a non-invasive exploratory method to assess airway inflammation in both upper and lower respiratory airways In Vietnam, there have only few studies been on the value of the CARATkids questionnaire as well as its correlation with the nitric oxide in the upper airways in patients with BA, especially in children with asthma and allergic rhinitis In order to evaluate the correlation between nNO concentration and asthma control status, we conducted the project "Study

of asthma control status in children with bronchial asthma and allergic rhinitis" with the following objectives:

1 Determining nasal nitric oxide threshold value in children with asthma and allergic rhinitis at Vietnam National Children's Hospital in the period 2016 - 2019

2 Evaluating asthma control status in children with asthma and allergic rhinitis

3 Determining asthma phenotype in children with asthma and allergic rhinitis

NEW FINDINGS OF THE THESIS Focus of the Thesis is studying the bronchial asthma in children with allergic rhinitis, which is a new problem in Vietnam Determining the nasal nitric oxide threshold value in children with asthma and allergic rhinitis and assess the status of asthma control in this subject Confirming the value of the questionnaire in assessing the simultaneous control of both asthma and allergic rhinitis in children (CARATkids) in Vietnamese children Identifying airway inflammation and asthma

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phenotype in children with asthma and allergic rhinitis provides the

clinicians with a basis for the decisive diagnosis and prevention of

bronchial asthma with allergic rhinitis

THESIS STRUCTURE

The thesis consists of 126 pages, including: introduction (2 pages),

literature review (36 pages), subjects and method (22 pages), results (32

pages), discussion (30 pages), conclusion (2 trang), some limitations of

the study (1 page), recommendations (1 page) There are 27 tables, 15

figures, 19 graphs, 4 diagrams, 2 appendices, 151 references in the

thesis

Chapter 1 LITERATURE REVIEW 1.1 Overview of Asthma and Allergic Rhinitis

1.1.1 Defination of asthma and allergic rhinitis

Defination of asthma: The Global Initiative for Asthma (GINA)

2020difined “Asthma is a heterogeneous desease, usually characterized

by chronic airway inflammation It is defined by the history of

respiratory symptoms such as wheeze, shortness of breath, chest

tightness and cough that vary over time and in intensity, together with

variable expiratory airflow limitation

Definition of allergic rhinitis: According to Allergic Rhinitis and

its Impact on Asthma (ARIA) 2008, rhinitis is defined as an

inflammation of the lining of the nose and is characterized by nasal

symptoms including anterior or posterior rhinorrhoea, sneezing, nasal

blockage and/or itching of the nose These symptoms occur during two

or more consecutive days for more than 1 hour on most days Allergic

rhinitis is clinically defined as a symptomatic disorder of the nose

induced after allergenexposure by an IgE-mediated inflammation

1.1.2 Epidemiology of Bronchial Asthma (BA) and Allergic Rhinitis (AR)

Epidemiological studies have shown that AR and BA often coexist in

the same patient Patients with moderate - severe persistent allergic rhinitis

have a higher risk of asthma than those with intermittent mild asthma Most

patients with asthma have symptoms of allergic rhinitis Rhinitis is an

independent allergic factor in asthma risks

1.1.3 Risks factors for bronchial asthma and allergic rhinitis

Asthma and allergic rhinitis often share common disease risk factors,

such as indoor and outdoor allergens, or medications like aspirin

1.1.4 The pathogenetic relationship between bronchial asthma and allergic rhinitis

There are now many controversial opinions about the pathogenesis of

BA, but it is agreed by most that BA is a complex disease characterized by airway chronic inflammation, hyperresponsiveness and structural changes, resulting in obstruction of airflow

Allergic rhinitis and bronchial asthma share the type 1 of allergy mechanism with the participation of IgE antibody Asthma and allergic rhinitis share the same allergen as a trigger factor The nasal and bronchial mucosa are similar, so they have similar reactivity

Both diseases are inflammatory airway diseases, with the same inflammatory cells and inflammatory mediators that are released by allergen exposure Asthma and rhinitis both cause airway obstruction

In addition, the upper airway has a protective role of the lower airway 1.1.5 Controlling allergic rhinitis helps to control bronchial asthma Children with asthma and allergic rhinitis are more likely to be hospitalized and incur higher treatment costs than the patients with asthma alone Allergic rhinitis greatly affects the life quality of children with bronchial asthma Therefore, good treatment of allergic rhinitis can contribute to well controlled of asthma

1.2 Asthma phenotype in children over 5 years old and adults The term “phenotype” (PNT) is intended to describe recognizable clinical features that are not directly related to the underlying pathophysiology In bronchial asthma, asthma phenotype describes the clinical features and inflammatory morphology as well as the responses

to treatment

In 2020, GINA classified asthma phenotypes as follows: allergic asthma; non-allergic asthma; late-onset asthma; asthma with persistent airflow limitation; asthma with obe sity

1.3 Diagnosis of bronchial asthma and allergic rhinitis 1.3.1 Diagnosis of asthma in children older than 5 years Diagnostic criteria of asthma in children older than 5 years old according to GINA 2016:

- Typical symptoms are wheeze, shortness of breath, chest tightness and cough

- Confirmed variable expiratory airflow limitation:

+ At least once during diagnostic process when FEV1 is low, confirm that FEV1/FVC is reduced

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+ An evidence of lung function changes compared with healthy

subjects:

• Increase in FEV1 of >12% predicted after administration of

bronchodilator

• Average daily diurnal PEF variability >13%

• Increase in FEV1 by >12% and >200 mL (or PEF† by >20%)

from baseline after 4 weeks of treatment, outside respiratory infections

+ Bronchial reconstitution test may be repeated when symptoms

are present in the morning or after bronchodilator administration

- Personal and family history: The child's history of previous recurrent

respiratory symptoms; the child may have allergic rhinitis or eczema

- Clinical examination: Clinical examination of asthmatic patients

usually shows no symptoms unless the patient is in an acute asthma

attack If a child has persistent asthma, the chest cavity may become

deformed

1.3.2 Diagnosis of allergic rhinitis

Diagnosis of allergic rhinitis according to ARIA 2008

- Personal and family history of allergies

- Functional symptoms: Having at least 2 of the following

symptoms (occurring frequently, lasting at least 1 hour/day): Clear

rhinorrhea; uninterrupted sneezing; stuffy nose; itchy nose; allergies in

the conjunctiva such as red, itchy eyes

- Physical symptoms: mucus excess on the floor of the inferiror

and middle sulcus rhinalis; enlarged and wet turbinates, especially

inferior turbinates; pale nasal mucosa; nasal polyps may exist

- Subclinical: Prick test may be positive for respiratory allergens;

specific IgE quantification; stimulation test with specific allergen

1.4 Treatment of bronchial asthma having allergic rhinitis

1.4.1 Targeted treatment of asthma having allergic rhinitis

- Control the current asthma symptoms

- Control the current allergic rhinitis symptoms

- Reduce the future risk of asthma and allergic rhinitis

1.4.2 Treatment regimen for asthma having allergic rhinitis

- Preventive treatment of plasma to GINA 2016 Asthma Treatment

Recommendations in children older than 5 years

- Treatment of allergic rhinitis to ARIA 2008 Allergic Rhinitis

Treatment Recommendations

- Simultaneous treatment regimen of asthma with allergic rhinitis: combination of both asthma and allergic rhinitis treatment regimens in which priority is given to drugs capable of simultaneously controlling asthma with allergic rhinitis such as LTRA, omalizumab, etc on request

1.4.3 Assessment of asthma and allergic rhinitis control

- Assessment of asthma control to GINA 2016

- Assessment of asthma control to the Asthma Control Test (ACT)

- Assessment of asthma and allergic rhinitis control to the Control allergic rhinitis and asthma test for children (CARATkids)

- Assessment of asthma control by exhaled nitric oxide level of the American Thoracic Society (ATS)

1.5 Role of nitric oxide in bronchial asthma and allergic rhinitis 1.5.1 Nitric oxide biosynthesis

The endogenous nitric oxide (NO) molecule is derived from the reaction between oxygen and nitrogen of the amino acid L-Arginin under the action of the enzyme NO synthase (NOS) There are three types of NOS enzymes in the bronchi participating in NO synthesis: NOS-1, NOS-2, and NOS-3 In which NOS-1 and NOS-3 always exist and produce NO continuously in small quantities, called basic NOS enzyme NOS-2 known as inducible NOS or iNOS is found in airway epithelial cells and some inflammatory cells, producing NO at a slower rate but in large quantities 1.5.2 Origin of nasal nitric oxide

Nasal nitric oxide (nNO) is produced in the nose and paranasal sinuses Each of these regions can contribute to the generation of nNO

In addition, nNO is produced by the nasal mucosal epithelium and inflammatory cells (eosinophils) involved in up-regulation of inducible nitric oxide (iNOS) enzymes The nasal cavity has a special vascular system that causes changes in nasal cavity volume and changes in the flow and/or volume of blood from nose, which could theoretically affect nNO production and absorption

1.5.3 Origin of bronchial nitric oxide Exhaled nitric oxide (FeNO) originates mainly from the bronchial epithelium In the presence of airway inflammation, NOS-2 is activated by airway epithelial cells and inflammatory cells increasing endogenous NO levels Under normal physiological conditions, the bronchial epithelium produces approximately 0.05 pico liters per second (pl/s) of NO over an area

of 1 cm2 In the presence of an inflammatory response, the airway epithelium

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produces approximately 7.4 pico liters per second per 1 cm2 area The

phenomenon of NO proliferation can last from 7-10 days

1.5.4 Role of nitric oxide in asthma and allergic rhinitis

FeNO levels provide a direct assessment of airway inflammation

associated with eosinophilia The change in FeNO levels manifests as early

as 1-2 weeks compared with the change in FEV1 after many months With

the eosinophilic asthma phenotype, FeNO significantly reduces in asthmatic

patients after corticosteroids administration This means, FeNO can assess

the severity of the inflammatory process as well as the degree of treatment

response to corticosteroids in asthmatic patients

nNO levels increase in people with allergic rhinitis Patients suffering

from allergic rhinitis with or withour bronchial asthma have statistically higher

levels of FeNO and nNO than those with vasomotor rhinitis and the controls

Several studies have shown a decrease in nNO level with topical

corticosteroids The nNO value is closely related to the outcome of asthma

control, especially in patients with asthma and allergic rhinitis nNO levels

have been suggested as a predictor of poor asthma control

1.5.5 Methods for measuring airway nitric oxide

Nowadays, there are three different techniques used to measure

exhaled nitric oxide: electrochemical sensors, chemiluminescence

sensors, and laser spectroscopy

FeNO and nNO levels are given in ppb (parts per billion) There are two

methods of measuring FeNO: online measurement and offline measurement

The most common method of measuring nNO is to insert a cannula into the

nasal cavity through the nostrils, aspirating the internal airflow (5 mL/s) while

the patient holding breath (10s) in order to have direct analysis of nitric oxide

level in the nose Another method is to measure nNO during air flow

circulating when the patient is still breathing normally through one nostril, air is

withdrawn through the other nostril at a rate of 5mL/s nNO can also be

measured through nasal mask with a single nasal exhalation at a fixed flow rate

using hand-held devices

1.6 Some studies on nitric oxide concentration and control of

bronchial asthma and allergic rhinitis in the World and Vietnam

1.6.1 Studies in the World

In 2005, Struben et al: study of the normal value of nNO in

children aged 6 to 17 years

2014, Kumar et al: Study of the correlation between FeNO, nNO

and allergic status in asthma and allergic rhinitis

In 2017, Amaral et al.: Study of the validation and the cutoff values

of the Control of Allergic Rhinitis and Asthma Test for children (CARATkids) in Brazil

1.6.2 Studies in Vietnam

In 2017, Duong Quy Sy et al.: Study of nNO concentrations in the diagnosis of allergic rhinitis in subjects with and without bronchial asthma

In 2018, Pham Khac Tiep: Study of applying the CARATkids scale

in asthma and allergic rhinitis control in children aged 6-12 at the Department of Immunology - Allergy - Rheumatology, Vietnam National Children's Hospital

In 2019, Duong Quy Sy et al.: Study of the therapeutic effect on nasal nitric oxide in patients with persistent allergic rhinitis

CHAPTER 2 SUBJECTS AND STUDY METHODS 2.1 Study Subjects

2.1.1 Patients with asthma and allergic rhinitis

- 124 patients diagnosed with bronchial asthma and allergic rhinitis who visited hospital for medical examination and treatment at Vietnam National Children's Hospital were invited to participate in the study

- Selection criteria

BA patients with AR: the patients diagnosed with bronchial asthma according to GINA 201654 and allergic rhinitis according to ARIA

2008 + Patients between 6 and 15 years old

+ Patients with BA diagnosed for the first time

+ Patients diagnosed with BA but has not received preventive treatment

+ Patients with BA that have quit prophylactic therapy for more than 3 months

+ Patients with allergic rhinitis symptoms, previously or currently examined and diagnosed with allergic rhinitis

+ Patients not in an acute asthma attack + Patients undergo the study with consent and supervision of the parents or regular caregivers

- Exclusion criteria + Patients classified as having stage 1 asthma with no indication for asthma prophylaxis

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+ Patients with asthma having other diseases such as congenital

heart disease, hepato-biliary disease, kidney and urinary tract

disease, neurological disorders, cognitive disorders, etc

+ Patients unable to understand and follow instructions when

participating in respiratory function and airway NO

concentration measurements

2.1.2 Controls

- Asthmatic patients without allergic rhinitis from 6 to 15 years of age

have the selection and exclusion criteria similar to those with bronchial asthma

having allergic rhinitis, but they don’t have allergic rhinitis

- Healthy children aged 6 -15 years old These children absolutely

have no history of wheezing, allergic rhinitis or other allergic

conditions; no systemic diseases No parents or siblings as family’s

history with asthma or allergic rhinitis

2.1.3 Study Location

- The study was conducted at the Department of Immunology -

Allergy - Rheumatology, Vietnam National Children's Hospital

2.1.4 Research time

- The study was conducted from October 1, 2016 to December 31,

2019

2.2 Study Methods

Study design:

- Objective 1: Cross-sectional descriptive study

- Objective 2: Longitudinal follow-up study, comparing before and

after treatment

- Objective 3: Descriptive study

Every asthmatic child with or without allergic rhinitis had been

invited to participate in the study four times:

1st time: at the first visit (T0)

2nd time: re-examination after 1 month (T1)

3rd time: re-examination after 3 months (T3)

4th time: re-examination after 6 months (T6)

Healthy children were invited to participate in the study once (T0):

children were examined and measured for airway nitric oxide levels and

respiratory function

2.2.1 Study sample size

- Applying the convenient sampling method: all children qualified

for selection and visited the Department of Immunology - Allergy -

Rheumatology during the study period were invited to participate in the study

Bronchial asthma group with allergic rhinitis

- Sample size for objective 1: Apply the formula to estimate the average index:

n = 2

(X )2

n: number of patients studied

With confidence interval 0,95 (α = 0,05) 2

ε : the relative deviation between the sample parameter and the population parameter, ranging from 0,05-0,5 (0,2-0,3)

S: variance

According to Struben's study, the value of nNO in healthy 6-17 years oldsis 449 ± 115 (ppb)91

1152

n = 1,962 * - = 101 (449x0,05)2

- Sample size for objectives 2 and 3: choose a convenient sample size

- At least 101 children with BA with AR were estimated to participate in the study

Asthmatic children without allergic rhinitis: As the percentage

of asthmatic children without allergic rhinitis is low, we purposefully selected 30 qualified asthmatic children without allergic rhinitis from 6

to 15 years old (22 boys; 8 girls) for the study

Healthy children: we selected 30 healthy children aged from 6 to

15 years old (19 boys; 11 girls) whose parents and they themselves agreed to participate in the study These are children who have regular health check-ups at the Vietnam National Children's Hospital

2.2.2 Study Steps Step 1: Selecting patients for the study (T0)

Patients visiting the National Children's Hospital for medical examination were asked about their illness, clinically examined, and tested to confirm the diagnosis of bronchial asthma (with and without accompanying allergic rhinitis)

Asthmatic children and their parents were interviewed for assessment of pre-treatment asthma control according to GINA criteria

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and ACT questionnaire, and asthmatic children with allergic rhinitis

were interviewed with a CARATkids questionnaire

Patients were appointed for blood count tests, IgE, respiratory

function measurement (CNHH), FeNO, nNO, prick test with respiratory

allergens

The healthy children were measured CNHH, FeNO, nNO

Step 2: Bronchial asthma was treated according to GINA 2016,

allergic rhinitis to ARIA 2008

Step 3: Re-examination, assessment of asthma control - allergic

rhinitis and adjustment of preventive medicine

- Time of re-examination:

After 1 month of treatment (T1), After 3 months of treatment (T3) After 6 months of treatment (T6)

- Clinical examination, checking for treatment adherence and

spraying method

- Interviewing the asthma control tables according to GINA, ACT

and CARATkids (for athmatic children with allergic rhinitis)

- Measuring FeNO, nNO and CNH

- Adjusting asthmatic prophylaxis according to GINA 2016

guidelines and allergic rhinitis controller according to ARIA 2008

Step 4: Input and process data

2.3 Data collection methods

2.3.1 General information and related factors

Ask and do a physical exam to gather the following information:

- Age

- Gender: male, female

- Weight and height

- BMI by age and sex

- Age of onset of wheezing

- Age at diagnosis of asthma

- Exposure to tobacco smoke

- Personal and family allergy history

- Level of asthma control according to GINA 2016

- Level of asthma control according to the ACT scale

- Control asthma and allergic rhinitis according to the CARATkids

scale

2.3.2 Paraclinical indicators

- Checking the blood count using automatic counter Sysmex

XN-3000 Quantifying IgE in blood by Cobus 6000 Prick testing with respiratory allergens using allergen preparations made by Stallergenes - France

- Measuring the respiratory function and testing for bronchial rehabilitation by KOKO device made in the US Measuring FeNO and nNO by HYPAIR FeNO of Medisoft, Belgium

2.4 Data processing The collected data was coded in a unified form; entered and analyzed using SPSS 16.0 software; suitable statistical algorithms were used

2.5 Study ethics Comply with the study ethics The study has been approved by the Ethics Committee of Hanoi Medical University, the Decision No 101/HĐĐĐHYHN

CHAPTER 3 STUDY RESULTS

- During the study period, there were 124 children with asthma and allergic rhinitis, 30 asthmatic children without allergic rhinitis and 30 healthy children aged from 6-15 years old who were eligible to participate

in the study

3.1 Characteristics of nasal nitric oxide in children with bronchial asthma having allergic rhinitis

*Nasal nitric oxide concentrations in children with asthma and allergic rhinitis, asthma without allergic rhinitis and healthy children

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The nNO concentration in children with BA-AR was 1594.5 (104 -

3674) ppb, higher than that in children with BA was 444.5 (105 - 2971)

ppb ((p<0.001), and 1055 (149 - 2090) ppb (p = 0.001) in healthy

children The concentration of nNO in the healthy children was higher

than that in group BA without AR, but the difference was not

statistically significant with p=0.053

* Area under the ROC curve of nasal nitric oxide in children with

asthma and allergic rhinitis

Area under

the ROC curve of nNO 95% confidence intervals Cut-off p

< 0,001

Se = 85,5%; Sp = 66,7%

The diagnostic value of allergic rhinitis in patients with BA with the

area under the ROC curve of nNO was 0.81; with the threshold value nNO =

605.5 ppb, the sensitivity was 85.5%, the specificity was 66.7%, p < 0.001

* Nasal nitric oxide concentration according to severity of allergic rhinitis

All children with BA and AR had high level of nNO In which, the

highest concentration of nNO in those with severe intermittent allergic

rhinitis was 2110 (367 - 3674) ppb and the lowest in those with mild intermittent allergic rhinitis was 1196 (104 - 2546) ppb The difference was statistically significant with p = 0.046

* The relationship between nNO concentration and certain factors

- There was no difference in nNO concentration by age, gender and weight in children with allergic rhinitis

- There was no association between cigarette smoke exposure and nNO concentration

- nNO concentration has a strong positive relationship with FEV1 (p = 0.01), FEV1/FVC (p = 0.02) and FeNO (p < 0.001)

3.2 Asthma control in children with asthma and allergic rhinitis

* Changes in average number of times using SABA per month

- The average number of times using SABA in a month in BA and

AR group decreased from 3.25 times to 1.70 ± 1.61 times after 1 month

of treatment, 1.03 ± 1.08 times after 3 months of treatment and 1.01 ± 1.26 times (p<0.001) after 6 months of treatment

* Changes in respiratory function during preventive treatment in children with asthma and allergic rhinitis

Values of repiratory function parameters

Before treatment (n=124)

X ± SD

1 month after treatment (n=97)

X ± SD

3 months after treatment (n=84)

X ± SD

6 months after treatment (n=77)

X ± SD

p

FVC 92,2 ± 18,4 98,6 ± 12,3 97,5 ± 13,3 96,8 ± 11,4 0,057 FEV1 85,6 ± 16,0 94,9 ± 12,7 93,8 ± 13,9 92,2 ± 12,2 0,007 FEV1/FVC 93,2 ± 10,4 96,9 ± 7,9 97,2 ± 7,9 96,2 ± 10,1 < 0,001 FEF25-75 70,3 ± 19,4 82,6 ± 17,9 83,1 ± 21,2 83,3 ± 20,1 < 0,001 PEF 67,7 ± 16,3 76,1 ± 13,0 78,1 ± 16,6 78,1 ± 16,2 < 0,001 All indicators of respiratory function improved with time of preventive treatment

* Results of asthma control in children with bronchial asthma and allergic rhinitis

- According to GINA, the number of children with well controlled asthma after 1 month is 45.4%; 65.5% after 3 months and 67.5% after 6 months, p<0.001

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- According to the ACT scale, the rate of asthma well controlled

after 1 month was 89.7%, 96.4% after 3 months and 96.1% after 6

months, p < 0.001

- According to the CARATkids scale with reference value of

Amaral et al (2017): the rate of well asthma and allergic rhinitis control

increased from 49.5% after 1 month of treatment to 66.2% after 6

months of treatment The rate of uncontrolled asthma and allergic

rhinitis decreased from 82.2% to 15.5% after 1 month of treatment;

5.2% after 6 months of treatment, p < 0.001

- According to FeNO concentration, the rate of asthma completely

controlled after 1 month, 3 months and 6 months of treatment was

61.8%, 78.6% and 76.6% respectively, 37.9% higher than before

treatment, p<0.001

* Cut-off point of CARATkids in uncontrolled asthma group after 1

month of treatment

Area under the curve 95% confidence intervals Cut-off p

Se = 100,0%; Sp = 79,8%

With CARATkids = 4.5 points, this limit was to define

uncontrolled asthma in children with asthma and allergic rhinitis; with

area under the curve of 0.957, the sensitivity was 100%, the specificity

was 79.8%, p < 0.001

* Changes in airway nitric oxide levels after asthma and allergic

rhinitis controls

- FeNO concentration before treatment was 29.8 ppb, and it was

decreased to 14.7 ppb after 6 months of preventive treatment, p<0.001

- The median nNO concentration decreased from 1592 (106 - 3302) ppb before treatment to 769 (100 - 2673) ppb after 6 months of treatment, p < 0.001

3.3 Asthma phenotype in chidlren with bronchial asthma and allergic rhinitis

* Asthma phenotype according to severity of allergic rhinitis

Characteristics

Severity of Allergic Rhinitis

p Mild AR

(n = 47)

Moderate-Seveve

AR (n = 77) FEV1 (%) (X ± SD) 87,7 ± 13,9 84,3 ±17,1 0,24 FEV1/FVC (%) (X ± SD) 93,1 ± 9,5 93,3 ± 10,9 0,89

Quantity of BCAT (BC/µl)

ICS dose (µg/day) (X ±

Number of patients after 6

ICS dose (µg/day) (X ± SD) after 6 months 267,7 ± 158,7 238,5 ± 123,5 0,63 SABA (X ± SD) after 6

FEV1 (%) (X ± SD) after 6

FEV1/FVC (%) (X ± SD) after 6 months 95,0 ± 10,2 96,7 ± 10,1 0,44

AR was divided into 2 groups: mild AR and moderate - severe AR The concentration of FeNO in asthmatic group with moderate-severe AR was higher than that in the group with mild AR, p < 0.001 The rate of well asthma control according to ACT was lower in the asthmatic group with moderate-severe AR, p < 0.05 The concentration of nNO, the number of eosinophils, the dose of ICS in the group with mild AR tended to be lower than in the group with moderate - severe AR After 6 months of preventive

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treatment, the group with moderate-severe AR had a higher average number

of SABA adminstration in a month (p = 0.02)

* Asthma phenotype according to nasal nitric oxide concentration

Characteristics

nNO

p

<605 ppb (n=18)

≥605 ppb (n=106) FEV1 (%) (X ± SD) 80,6 ± 16,1 86,4 ± 15,9 0,19

FEV1/FVC (%) (X ± SD) 91,1 ± 9,8 93,6 ± 10,5 0,28

Quantity of BCAT (BC/µl)

IgE in blood (IU/ml) (median) 390,4 910,6 0,002

ICS dose (µg/day) (X ± SD) 347,2 ± 125,4 318,0 ± 123,9 0,36

Number of patients after 6

ICS dose (µg/day) (X ± SD)

after 6 months 300,0 ± 158,1 239,9 ± 131,3 0,25

SABA (X ± SD) after 6 months 1,0 ± 1,33 0,57 ± 1,32 0,36

FEV1 (X ± SD) after 6 months 87,0 ± 14,3 93,0 ± 11,8 0,34

FEV1/FVC (X ± SD) after 6

Classification of asthma phenotypes by nNO showed that the group

with nNO concentration < 605ppb had lower FeNO concentration (p =

0.009), lower number of eosinophils (p = 0.03) and IgE concentration (p =

0.002) compared with the group with nNO concentration ≥ 605ppb There

was no difference in the results of asthma control according to ACT between

the 2 groups before treatment However, the indicators FEV1, FEV1/FVC

improved markedly after 6 months of preventive treatment

* Asthma phenotype according to FEV1 values

<80 % (n=38) 80-90 % (n=37) >90% (n=49) FVC (%) (X ± SD) 79,6 ± 25,2 91,8 ± 8,3 102,2 ± 9,7 <0,001 FEV1/FVC (%)

(X ± SD) 86,5 ± 11,1 93,7 ± 8,3 98,0 ± 8,4 <0,001

IgE in blood (IU/ml)

Number of eosinophils

ACT ≥ 20 (%) 9 (23,7) 13 (35,1) 27 (55,1) 0,01 ICS dose (µg/day)

(X ± SD) 390,5 ± 127,4 332,6 ± 124,5 262,0 ± 88,6 < 0,001 Number of patients

ICS dose (µg/day) (X ± SD) after 6 months

277,2 ± 155,2 270,8 ± 125,9 201,4 ± 117,0 0,07

SABA (X ± SD) after

FEV1 (%) (X ± SD) after 6 months 88,5 ± 13,2 90,7 ± 12,7 96,9 ± 9,6 0,031 FEV1/FVC (%)

(X ± SD) after 6 months

93,6 ± 11,6 97,4 ± 9,5 97,5 ± 9,0 0,29 FEV1 was divided into 3 groups, the group with normal FEV1 (>90%), the group with slightly decreased FEV1 (80-90%) and the group with clearly reduced FEV1 (<80%) The group with clearly reduced FEV1 had the lowest FeNO and nNO (p = 0.06 and p = 0.03), and this group also had a higher demand for ICS treatment than the other 2 groups (p < 0.001) Before treatment, the rate of well controlled asthma by ACT in the group with clearly reduced FEV1 (<80%) was lower than that of the other two groups (p = 0.01) After 6 months of treatment, the group with low FEV1 had a higher average number of SABA administraton (p = 0.04) and a lower FEV1 indicator (p =

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