Effects of Montelukast in Asthmatic Children With and Without Food Allergy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hacettepe University
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Cansin Sackesen, Hacettepe University
ClinicalTrials.gov Identifier:
NCT01618929
First received: June 12, 2012
Last updated: August 17, 2014
Last verified: August 2014
  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:


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:
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
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
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014