NCT01618929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

June 12, 2012

Last Update Submit

August 11, 2017

Conditions

Bronchial AsthmaFood AllergyChildren

Keywords

Food allergyAsthmaChildrenMontelukastInflammation

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 weeks

Secondary Outcomes (4)

  • Exhaled breath condensate

    14 weeks

  • Fractional exhaled Nitric Oxide

    14 weeks

  • asthma control test

    14 weeks

  • bronchial hyperreactivity

    14 weeks

Study Arms (2)

asthma with food allergy

ACTIVE COMPARATOR

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

asthma without food allergy

ACTIVE COMPARATOR

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

Interventions

MontelukastDRUG

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.

Also known as: Singulair 5 mg tablets, Singulair 10 mg tablets, Placebo 5 mg tablets, Placebo 10 mg tablets
asthma with food allergyasthma without food allergy

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cansin Sackesen

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 15696076BACKGROUND

  • 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.

    PMID: 20816189BACKGROUND

MeSH Terms

Conditions

AsthmaFood HypersensitivityInflammation

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cansin Sackesen, Assoc Prof

    Hacettepe University

    STUDY CHAIR

  • Umit M Sahiner, MD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

  • Betul Buyuktiryaki, MD, fellow

    Hacettepe University

    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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 13, 2012

Study Start

March 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2016

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations

TU(1)