The Effect of Cow Milk Consumption on Respiratory Symptoms and Pulmonary Functions in Asthmatic and Non Asthmatic Children

Study Overview
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Brief Summary
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the investigators hypothesis is that milk consumption, either in the acute phase and through prolonged exposure, does not cause or increase respiratory symptoms or airway inflammation. the investigators aim to objectively prove this by examining respiratory symptoms and signs and objectively measuring parameters of airway inflammation and hyper responsiveness after consumption of cow milk or soy milk substitute.

Detailed Description
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In this prospective single blinded placebo controlled trial, acute milk consumption will be evaluated. 50 asthmatic and 50 healthy children aged 6-18 will drink 240 ml of cow milk or soy milk substitute. Respiratory symptoms by questionnaire and physical examination will be evaluated. Airway response and inflammation will be assessed by fraction of exhaled Nitric Oxide (FENO) and spirometry before and after the exposure.

Official Title
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The Effect of Cow-milk Consumption on Respiratory Symptoms and Pulmonary Functions in Asthmatic and Non-asthmatic Children

Conditions
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Asthma

Intervention / Treatment
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* Dietary Supplement: Cow milk
* Dietary Supplement: Soy milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children Asthmatic children Exclusion Criteria: Known allergy to cow milk Children had upper / lower respiratory disease in two weeks prior the study. Children who had been treated in systemic steroids in the month prior the study. Intolerant children to cow milk.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Soy milk substitute Healthy<br>Healthy children aged 6-18 will drink 240 ml of soy milk substitute. | Dietary Supplement: Soy milk<br>* Ingestion of 240 ml soy milk<br>|
| Active Comparator: Soy milk substitute Asthma<br>Asthmatic children aged 6-18 will drink 240 ml of soy milk substitute. | Dietary Supplement: Soy milk<br>* Ingestion of 240 ml soy milk<br>|
| Experimental: Cow milk Healthy<br>Healthy children aged 6-18 will drink 240 ml of cow milk. | Dietary Supplement: Cow milk<br>* Ingestion of 240 ml cow milk<br>|
| Experimental: Cow milk Asthma<br>Asthmatic children aged 6-18 will drink 240 ml of cow milk. | Dietary Supplement: Cow milk<br>* Ingestion of 240 ml cow milk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough and mucus production according to patient's report and physical examination | subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no | Baseline | 
| Cough and mucus production according to patient's report and physical examination | subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no | 30 minutes after the intervention | 
| Cough and mucus production according to patient's report and physical examination | subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no | 60 minutes after the intervention | 
| Cough and mucus production according to patient's report and physical examination | subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no | 90 minutes after the intervention | 
| Cough and mucus production according to patient's report and physical examination | subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no | 120 minutes after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of exhaled Nitric Oxide (FeNO) | single breath method: This test measures the concentration of NO in the exhaled air. In this method the patient takes a deep breath from the filter device and exhales the air at a constant rate of 50 mL / min for 12 seconds. The results of each test will be the average value of three tests. General measurement: overall system to be measured FENO device Denox 88 (ECO Medics AG, Switzerland), and nitric oxide 88 CLD analyzer which was approved for use by the FDA's medical device approval if the Ministry of Health. The values are in parts per billion (Ppb). children aged 5-6 years are able to perform this test. FENO values: Low FENO: 0-5 ppb in Children Normal FENO: 5-20 ppb in children Mild elevated FENO:20-30 ppb in children High FENO: 30-70 ppb in Children Severe FENO: >70 ppb in Children | Baseline | 
| Fraction of exhaled Nitric Oxide (FeNO) | single breath method: This test measures the concentration of NO in the exhaled air. In this method the patient takes a deep breath from the filter device and exhales the air at a constant rate of 50 mL / min for 12 seconds. The results of each test will be the average value of three tests. General measurement: overall system to be measured FENO device Denox 88 (ECO Medics AG, Switzerland), and nitric oxide 88 CLD analyzer which was approved for use by the FDA's medical device approval if the Ministry of Health. The values are in parts per billion (Ppb). children aged 5-6 years are able to perform this test. FENO values: Low FENO: 0-5 ppb in Children Normal FENO: 5-20 ppb in children Mild elevated FENO:20-30 ppb in children High FENO: 30-70 ppb in Children Severe FENO: >70 ppb in Children | 30 minutes after the intervention | 
| Fraction of exhaled Nitric Oxide (FeNO) | single breath method: This test measures the concentration of NO in the exhaled air. In this method the patient takes a deep breath from the filter device and exhales the air at a constant rate of 50 mL / min for 12 seconds. The results of each test will be the average value of three tests. General measurement: overall system to be measured FENO device Denox 88 (ECO Medics AG, Switzerland), and nitric oxide 88 CLD analyzer which was approved for use by the FDA's medical device approval if the Ministry of Health. The values are in parts per billion (Ppb). children aged 5-6 years are able to perform this test. FENO values: Low FENO: 0-5 ppb in Children Normal FENO: 5-20 ppb in children Mild elevated FENO:20-30 ppb in children High FENO: 30-70 ppb in Children Severe FENO: >70 ppb in Children | 60 minutes after the intervention | 
| Fraction of exhaled Nitric Oxide (FeNO) | single breath method: This test measures the concentration of NO in the exhaled air. In this method the patient takes a deep breath from the filter device and exhales the air at a constant rate of 50 mL / min for 12 seconds. The results of each test will be the average value of three tests. General measurement: overall system to be measured FENO device Denox 88 (ECO Medics AG, Switzerland), and nitric oxide 88 CLD analyzer which was approved for use by the FDA's medical device approval if the Ministry of Health. The values are in parts per billion (Ppb). children aged 5-6 years are able to perform this test. FENO values: Low FENO: 0-5 ppb in Children Normal FENO: 5-20 ppb in children Mild elevated FENO:20-30 ppb in children High FENO: 30-70 ppb in Children Severe FENO: >70 ppb in Children | 90 minutes after the intervention | 
| Fraction of exhaled Nitric Oxide (FeNO) | single breath method: This test measures the concentration of NO in the exhaled air. In this method the patient takes a deep breath from the filter device and exhales the air at a constant rate of 50 mL / min for 12 seconds. The results of each test will be the average value of three tests. General measurement: overall system to be measured FENO device Denox 88 (ECO Medics AG, Switzerland), and nitric oxide 88 CLD analyzer which was approved for use by the FDA's medical device approval if the Ministry of Health. The values are in parts per billion (Ppb). children aged 5-6 years are able to perform this test. FENO values: Low FENO: 0-5 ppb in Children Normal FENO: 5-20 ppb in children Mild elevated FENO:20-30 ppb in children High FENO: 30-70 ppb in Children Severe FENO: >70 ppb in Children | 120 minutes after the intervention | 
| Spirometry - Forced expiratory flow 1 sec | This test measures how much air is moved in and out of the lungs and how fast the air moves. the patient will be asked to take in a deep breath and to blow the air out into a filter that is connected to a computer. computer measures how much and how fast the air is blown out. Each test will be performed three times and the average value choice.Forced expiratory flow 1 sec (percent of predicted value) is the value that will be compared before and after the intervention. | Baseline | 
| Spirometry - Forced expiratory flow 1 sec | This test measures how much air is moved in and out of the lungs and how fast the air moves. the patient will be asked to take in a deep breath and to blow the air out into a filter that is connected to a computer. computer measures how much and how fast the air is blown out. Each test will be performed three times and the average value choice.Forced expiratory flow 1 sec (percent of predicted value) is the value that will be compared before and after the intervention. | 30 minutes after the intervention | 
| Spirometry - Forced expiratory flow 1 sec | This test measures how much air is moved in and out of the lungs and how fast the air moves. the patient will be asked to take in a deep breath and to blow the air out into a filter that is connected to a computer. computer measures how much and how fast the air is blown out. Each test will be performed three times and the average value choice.Forced expiratory flow 1 sec (percent of predicted value) is the value that will be compared before and after the intervention. | 60 minutes after the intervention | 
| Spirometry - Forced expiratory flow 1 sec | This test measures how much air is moved in and out of the lungs and how fast the air moves. the patient will be asked to take in a deep breath and to blow the air out into a filter that is connected to a computer. computer measures how much and how fast the air is blown out. Each test will be performed three times and the average value choice.Forced expiratory flow 1 sec (percent of predicted value) is the value that will be compared before and after the intervention. | 90 minutes after the intervention | 
| Spirometry - Forced expiratory flow 1 sec | This test measures how much air is moved in and out of the lungs and how fast the air moves. the patient will be asked to take in a deep breath and to blow the air out into a filter that is connected to a computer. computer measures how much and how fast the air is blown out. Each test will be performed three times and the average value choice.Forced expiratory flow 1 sec (percent of predicted value) is the value that will be compared before and after the intervention. | 120 minutes after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, cow milk, pulmonary function testing, children, mucus