Effects of Montelukast in Asthmatic Children With and Without Food Allergy - Full Text View

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	Intervention	Phase
Bronchial Asthma Food Allergy Children	Drug: Montelukast	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma Food Allergy

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Hacettepe University:

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.

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)


Estimated Enrollment:	120
Study Start Date:	March 2013
Estimated Study Completion Date:	April 2016
Estimated Primary Completion Date:	October 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).	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
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)	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

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


Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618929

Contacts


Contact: Cansin Sackesen, Assoc Prof	90 312 305 1700 ext 90 532 2128787	cansinsackesen@gmail.com
Contact: Umit M Sahiner, MD,	90 312 305 1700 ext 90 532 5912787	umsahner@yahoo.com

Locations


Turkey
Cansin Sackesen	Recruiting
Ankara, Turkey, 06100
Contact: Cansin Sackesen, Professor 90 312 305 1700 csackesen@yahoo.com
Contact: Umit M Sahiner, Assoc Prof 90 532 5912787 umsahner@yahoo.com
Sub-Investigator: Umit M Sahiner, Assoc Prof
Sub-Investigator: Ebru Arik Yilmaz, Specialist
Sub-Investigator: Ozge Uysal Soyer, Assoc Prof
Cansin Sackesen	Recruiting
Ankara, Turkey, 06100
Contact: Cansin Sackesen, Assoc Prof 90 312 305 1700 ext 90 533 2128787 cansinsackesen@gmail.com
Sub-Investigator: Umit M Sahiner, MD
Sub-Investigator: Betul Buyuktiryaki, MD, fellow
Sub-Investigator: Ozlem Cavkaytar, MD, fellow
Sub-Investigator: Ebru Arikyılmaz, MD, fellow
Sub-Investigator: Ozge U Soyer, Assist Prof
Sub-Investigator: Ayfer Tuncer, Professor

Sponsors and Collaborators

Hacettepe University

Merck Sharp & Dohme Corp.

Investigators


Study Chair:	Cansin Sackesen, Assoc Prof	Hacettepe University, Ankara, Turkey
Principal Investigator:	Umit M Sahiner, MD	Hacettepe University, Ankara, Turkey
Principal Investigator:	Betul Buyuktiryaki, MD, fellow	Hacettepe University, Ankara, Turkey
Principal Investigator:	Ozlem Cavkaytar, MD, fellow	Hacettepe University
Principal Investigator:	Ebru Arikyılmaz, MD, fellow	Hacettepe University
Principal Investigator:	Ayfer Tuncer, Professor	Hacettepe University
Principal Investigator:	Ozge U Soyer, Assist Prof	Hacettepe University

More Information

Publications:

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.

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. Erratum in: J Allergy Clin Immunol. 2010 Nov;126(5):959-61. Dosage error in article text.


Responsible Party:	Cansin Sackesen, Associate Professor, Hacettepe University
ClinicalTrials.gov Identifier:	NCT01618929 History of Changes
Other Study ID Numbers:	MISP Protocol 1.0
Study First Received:	June 12, 2012
Last Updated:	August 17, 2014
Health Authority:	Turkey: Ministry of Health

Keywords provided by Hacettepe University:


Food allergy Asthma Children Montelukast Inflammation

Additional relevant MeSH terms:


Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Montelukast Anti-Asthmatic Agents Hormone Antagonists	Hormones, Hormone Substitutes, and Hormone Antagonists Leukotriene Antagonists Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015