Effects of Montelukast in Asthmatic Children With and Without Food Allergy
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| ClinicalTrials.gov Identifier: NCT01618929 |
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Recruitment Status :
Completed
First Posted : June 13, 2012
Last Update Posted : August 14, 2017
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Sponsor:
Hacettepe University
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Cansin Sackesen, Hacettepe University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bronchial Asthma Food Allergy Children | Drug: Montelukast | Phase 4 |
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 (Clinical Trial) |
| Actual Enrollment : | 113 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | March 2013 |
| Actual Primary Completion Date : | May 2015 |
| Actual Study Completion Date : | May 2016 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Montelukast
| Arm | Intervention/treatment |
|---|---|
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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).
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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:
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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)
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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:
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Primary Outcome Measures :
- the difference in FEV1% between two arms. [ Time Frame: 10 weeks ]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 ]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 ]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 ]
- bronchial hyperreactivity [ Time Frame: 14 weeks ]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)
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| Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618929
Locations
| Turkey | |
| Cansin Sackesen | |
| Ankara, Turkey, 06100 | |
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 |
Publications:
| Responsible Party: | Cansin Sackesen, Associate Professor, Hacettepe University |
| ClinicalTrials.gov Identifier: | NCT01618929 History of Changes |
| Other Study ID Numbers: |
MISP Protocol 1.0 |
| First Posted: | June 13, 2012 Key Record Dates |
| Last Update Posted: | August 14, 2017 |
| Last Verified: | August 2017 |
Keywords provided by Cansin Sackesen, Hacettepe University:
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Food allergy Asthma Children Montelukast Inflammation |
Additional relevant MeSH terms:
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Hypersensitivity Food Hypersensitivity Asthma Immune System Diseases Hypersensitivity, Immediate Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity |
Montelukast Anti-Asthmatic Agents Respiratory System Agents Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP1A2 Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action |