Effects of Montelukast in Asthmatic Children With and Without Food Allergy

NCT ID: NCT01618929

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-05-31

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.

Conditions

Bronchial Asthma; Food Allergy; Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Montelukast

Intervention Type: DRUG

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.

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)

Group Type: ACTIVE_COMPARATOR

Montelukast

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Singulair 5 mg tablets; Singulair 10 mg tablets; Placebo 5 mg tablets; Placebo 10 mg tablets

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Cansin Sackesen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cansin Sackesen, Assoc Prof

Role: STUDY_CHAIR

Hacettepe University, Ankara, Turkey

Umit M Sahiner, MD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University, Ankara, Turkey

Betul Buyuktiryaki, MD, fellow

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University, Ankara, Turkey

Ozlem Cavkaytar, MD, fellow

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Ebru Arikyılmaz, MD, fellow

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Ayfer Tuncer, Professor

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Ozge U Soyer, Assist Prof

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Cansin Sackesen

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 15696076 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20816189 (View on PubMed)

Other Identifiers

MISP Protocol 1.0

Identifier Type: -

Identifier Source: org_study_id