Effects of Montelukast in Asthmatic Children With and Without Food Allergy

Hacettepe University

Status and phase: Completed; Phase 4

Conditions: Food Allergy; Bronchial Asthma; Children

Treatments: Drug: Montelukast

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01618929

MISP Protocol 1.0

Details and patient eligibility

About

• 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.

Full description

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.

Enrollment: 113 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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113 participants in 2 patient groups

asthma with food allergy

Active Comparator group

Description:

The study will be performed in 2 groups of patients (Patients with and without food allergy) parallel to each other at the same time and within each group the patients will take montelukast and placebo (one after another in a double-blind design).

Treatment:

Drug: Montelukast

asthma without food allergy

Active Comparator group

Description:

The study will be performed in 2 groups of patients (Patients with and without food allergy) parallel to each other at the same time and within each group the patients will take montelukast and placebo (one after another in a double-blind design)

Treatment:

Drug: Montelukast