Effects of Montelukast in Asthmatic Children With and Without Food Allergy
Effects of Montelukast in Asthmatic Children With and Without Food Allergy
-  To search the effects of montelukast on the airway inflammation including FEV1%,
 FEV1%/FVC, the provocholine® (methacoline chloride powder for inhalation) challenge
 tests, the leukotriene levels in the exhaled breath condensate in asthmatic children
 with and without food allergy aged 6-18 years old.

 -  To define the patient groups with good response to montelukast and to define the
 parameters which predict the good response.
The aim of this analysis is to determine whether the children with food allergy may have more
 eosinophilic inflammation in the airways (as measured by FENO) or they may have Cysteinyl
 leukotrienes based inflammation in the airways that will be shown by high levels of Cys LT
 and low levels of lipoxin in the exhaled breath condensate. Our suggestion is that a special
 pattern of inflammation may be seen in asthmatics with food allergy because of their strong
 atopic march history and then we aimed to test if montelukast is more effective in children
 when the ratio of Cysteinyl LT inflammation is high relative to FENO (eosinophilic
 inflammation). This study will be the first to evaluate the effect of montelukast regarding
 the synthesis of Cys leukotrienes, lipoxin and FENO that will be measured from exhaled breath
 condensate, which is the mirror of the local inflammation in the airways in asthmatic
 children with atopy (food allergy). As we mentioned above another factor that we are planning
 to analyze is the ratio of Cys leukotriene to lipoxin, which is the natural antagonist of LT.
 This study will determine the ratio of Cyst LT to lipoxin and Cyst LT to FENO in the exhaled
 breath condensate and then there will be an analysis to see the correlation of these
 inflammatory markers with montelukast related changes on FEV1%, FEV1%/FVC.
Inclusion Criteria:

 -  Physician diagnosed asthma (12% reversibility on spirometry test or positive response
 to provocholine® provocation test).

 -  Mild to moderate asthmatic children. Asthmatic children with pre-budesonide FEV1/FVC ≥
 80% will be included.

 -  At least one food allergy confirmed by specific IgE level or skin prick test
 positivity and a relevant clinical history or open challenge test with food.

 -  Aged between 6-18 years old.

 -  Acceptance of involvement in the study and signed informed consent (Both patients and
 one of the parents)

 Exclusion Criteria:

 -  Who does not sign the informed consent.

 -  Severe asthmatic children

 -  Any lung disease except asthma (i.e. cystic fibrosis, bronchiectasia, primary ciliary
 dyskinesia).

 -  Any systemic disease except allergic rhinitis and atopic dermatitis

 -  Follow-up in intensive care unit or intubation for asthma exacerbation within one
 year.

 -  Attendance to emergency room or hospital admission within 3 months for asthma
 exacerbation

 -  Systemic steroid usage within 3 months

 -  Upper airway infection within one month.

 -  Psychiatric or psychosocial problems

 -  Poor compliance to asthma treatment protocol

 -  Any condition contra-indicated for montelukast usage

 -  To be aware of the name of the drug either patient or study staff during the study
 period.

 -  Worsening of the clinical condition during run-in period.

 -  Pregnancy or breast feeding