Clinical trial NCT01618929: Effects of Montelukast in Asthmatic Children With and Without Food Allergy
Official title: Phase 4 Study of Effects of Montelukast Treatment on Allergic Inflammation in Children With and Without Food Allergy, Single Centered, Randomised, Double Blind, Placebo Controlled Parallel Group Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchial Asthma
Food Allergy
Children
Keywords: Food allergy
Asthma
Children
Montelukast
Inflammation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-06-13
Enrollment: 113
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: the difference in FEV1% between two arms.
timeFrame: 10 weeks
Secondary outcomes:
measure: Exhaled breath condensate
timeFrame: 14 weeks
measure: Fractional exhaled Nitric Oxide
timeFrame: 14 weeks
measure: asthma control test
timeFrame: 14 weeks
measure: bronchial hyperreactivity
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Cansin Sackesen
Study officials:
affiliation: Hacettepe University, Ankara, Turkey
name: Cansin Sackesen, Assoc Prof
role: STUDY_CHAIR
affiliation: Hacettepe University, Ankara, Turkey
name: Umit M Sahiner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University, Ankara, Turkey
name: Betul Buyuktiryaki, MD, fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ozlem Cavkaytar, MD, fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ebru Arikyılmaz, MD, fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ayfer Tuncer, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ozge U Soyer, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szefler SJ, Phillips BR, Martinez FD, Chinchilli VM, Lemanske RF, Strunk RC, Zeiger RS, Larsen G, Spahn JD, Bacharier LB, Bloomberg GR, Guilbert TW, Heldt G, Morgan WJ, Moss MH, Sorkness CA, Taussig LM. Characterization of within-subject responses to fluticasone and montelukast in childhood asthma. J Allergy Clin Immunol. 2005 Feb;115(2):233-42. doi: 10.1016/j.jaci.2004.11.014.
citation: Rabinovitch N, Graber NJ, Chinchilli VM, Sorkness CA, Zeiger RS, Strunk RC, Bacharier LB, Martinez FD, Szefler SJ; Childhood Asthma Research and Education Network of the National Heart, Lung, and Blood Institute. Urinary leukotriene E4/exhaled nitric oxide ratio and montelukast response in childhood asthma. J Allergy Clin Immunol. 2010 Sep;126(3):545-51.e1-4. doi: 10.1016/j.jaci.2010.07.008.