Effects of Montelukast in Asthmatic Children With and Without Food Allergy

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

• 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hacettepe University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Montelukast

Criteria

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