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Effects of Montelukast in Asthmatic Children With and Without Food Allergy

NCT01618929 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2017-08-14

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Cansin Sackesen, Assoc Prof · Hacettepe University, Ankara, Turkey

  • Umit M Sahiner, MD · Hacettepe University, Ankara, Turkey

  • Betul Buyuktiryaki, MD, fellow · Hacettepe University, Ankara, Turkey

  • Ozlem Cavkaytar, MD, fellow · Hacettepe University

  • Ebru Arikyılmaz, MD, fellow · Hacettepe University

  • Ayfer Tuncer, Professor · Hacettepe University

  • Ozge U Soyer, Assist Prof · Hacettepe University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-05-31
Completion
2016-05-31

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01618929 on ClinicalTrials.gov