Effects of Montelukast in Asthmatic Children With and Without Food Allergy | RxWiki

Effects of Montelukast in Asthmatic Children With and Without Food Allergy

Overview[ - collapse ][ - ]

Purpose	- 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.
Condition	Bronchial Asthma Food Allergy Children
Intervention	Drug: Montelukast
Phase	Phase 4
Sponsor	Hacettepe University
Responsible Party	Hacettepe University
ClinicalTrials.gov Identifier	NCT01618929
First Received	June 12, 2012
Last Updated	June 12, 2012
Last verified	June 2012

Tracking Information[ + expand ][ + ]

First Received Date	June 12, 2012
Last Updated Date	June 12, 2012
Start Date	September 2012
Estimated Primary Completion Date	June 2013
Current Primary Outcome Measures	the difference in FEV1% between two arms. [Time Frame: 10 weeks] [Designated as safety issue: Yes]The asthmatic children with and without food allergy will be given placebo and montelukast following one another in a cross over design. 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. A total of 5 spirometry tests (At the beginning and end of run-in periods, at the beginning of cross-over period, at the end of wash-out period and at the end of the study) will be done and forced expiratory volume in one second (FEV1) will be evaluated.
Current Secondary Outcome Measures	Exhaled breath condensate [Time Frame: 14 weeks] [Designated as safety issue: No]It will be collected 4 times during the study period (At the beginning and at the end of drug and placebo usage periods.)Cysteinyl leukotrienes, Prostaglandin D2, lipoxin levels will be measured in the exhaled breathe condensate Fractional exhaled Nitric Oxide [Time Frame: 14 weeks] [Designated as safety issue: No]It's measurement will be done 4 times during the study period (At the beginning and at the end of drug and placebo usage periods.) (See flow chart). asthma control test [Time Frame: 14 weeks] [Designated as safety issue: No] bronchial hyperreactivity [Time Frame: 14 weeks] [Designated as safety issue: No]In order to document the level of bronchial hyperreactivity of the patients, the provocholine (methacholine chloride powder for inhalation) provocation tests will be performed 4 times (At the beginning and at the end of drug and placebo usage periods)

Descriptive Information[ + expand ][ + ]

Brief Title	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
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Bronchial Asthma Food Allergy Children
Intervention	Drug: Montelukast Placebo and montelukast (5 mg for 6-14 years of age and 10 mg for 14-18 years of age once a day) will be given following one another in 4 weeks periods including a 2 weeks wash-out period in between in a cross over design. Other Names: Singulair 5 mg tablets Singulair 10 mg tablets Placebo 5 mg tablets Placebo 10 mg tablets
Study Arm (s)	Active Comparator: asthma with food allergy 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). Active Comparator: asthma without food allergy 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)

Recruitment Information[ + expand ][ + ]

Recruitment Status	Not yet recruiting
Estimated Enrollment	120
Estimated Completion Date	June 2013
Estimated Primary Completion Date	March 2013
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
Gender	Both
Ages	6 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Cansin Sackesen, Assoc Prof 90 312 305 1700 cansinsackesen@gmail.com
Location Countries	Turkey

Administrative Information[ + expand ][ + ]

NCT Number	NCT01618929
Other Study ID Numbers	MISP Protocol 1.0
Has Data Monitoring Committee	Yes
Information Provided By	Hacettepe University
Study Sponsor	Hacettepe University
Collaborators	Merck Sharp & Dohme Corp.
Investigators	Study Chair: Cansin Sackesen, Assoc Prof Hacettepe University, Ankara, TurkeyPrincipal Investigator: Umit M Sahiner, MD Hacettepe University, Ankara, TurkeyPrincipal Investigator: Betul Buyuktiryaki, MD, fellow Hacettepe University, Ankara, TurkeyPrincipal Investigator: Ozlem Cavkaytar, MD, fellow Hacettepe UniversityPrincipal Investigator: Ebru Arikyılmaz, MD, fellow Hacettepe UniversityPrincipal Investigator: Ayfer Tuncer, Professor Hacettepe UniversityPrincipal Investigator: Ozge U Soyer, Assist Prof Hacettepe University
Verification Date	June 2012

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