Asthma
Conditions
Keywords
asthma, cow milk, pulmonary function testing, children, mucus
Brief summary
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
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.
Interventions
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough and mucus production according to patient's report and physical examination | Baseline | subjective report by the parents including: appearance of cough, rhinitis and objective physical examinations signs including: wheezing, rales, cough- yes or no |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fraction of exhaled Nitric Oxide (FeNO) | Baseline | 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 |
| Spirometry - Forced expiratory flow 1 sec | Baseline | 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. |
Contacts
Primary ContactKeren Armoni Domany, Doctor
Outcome results
None listed