Effects of Montelukast in Asthmatic Children With and Without Food Allergy

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Montelukast

About this trial

This is an interventional treatment trial for Bronchial Asthma focused on measuring Food allergy, Asthma, Children, Montelukast, Inflammation

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cansin Sackesen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

asthma with food allergy

asthma without food allergy

Arm Description

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).

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)

Outcomes

Primary Outcome Measures

the difference in FEV1% between two arms.

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

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

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

bronchial hyperreactivity

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)

Full Information

NCT ID

NCT01618929

First Posted

June 12, 2012

Last Updated

August 11, 2017

Sponsor

Hacettepe University

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01618929

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hacettepe University

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchial Asthma, Food Allergy, Children

Keywords

Food allergy, Asthma, Children, Montelukast, Inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

asthma with food allergy

Arm Type

Active Comparator

Arm Description

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).

Arm Title

asthma without food allergy

Arm Type

Active Comparator

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Montelukast

Other Intervention Name(s)

Singulair 5 mg tablets, Singulair 10 mg tablets, Placebo 5 mg tablets, Placebo 10 mg tablets

Intervention Description

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.

Primary Outcome Measure Information:

Title

the difference in FEV1% between two arms.

Description

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.

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

Exhaled breath condensate

Description

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

Time Frame

14 weeks

Title

Fractional exhaled Nitric Oxide

Description

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).

Time Frame

14 weeks

Title

asthma control test

Time Frame

14 weeks

Title

bronchial hyperreactivity

Description

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)

Time Frame

14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials: