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Usefulness of Exhaled Breath Condensate for Evaluation of Markers of Airway Inflammation in Children With Asthma

NCT00961155 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-12-10

No results posted yet for this study

Summary

Exhaled breath condensate (EBC) has emerged as a novel noninvasive technique for assessment of airway inflammation, and it provides information on airway lining fluid composition. Traditionally, such assessment relies on invasive diagnostic tools such as bronchial biopsy and bronchoalveolar lavage (BAL) to obtain specimens from the airway but it is very uncomfortable procedure especially for young patients. The aim of this study is to evaluate the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma allergic to house dust mite. Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction as another phenotype of asthma.

Conditions

Interventions

DRUG

cyklezonid

160 mcg once daily

DRUG

montelukast sodium

5 or 10 mg according to age once daily

DRUG

placebo

fluticasone placebo twice daily, montelukast placebo once daily

DRUG

formoterol 12 mcg twice daily

formoterol 12 mcg twice daily will be given to children for 3 months

Sponsors & Collaborators

  • Medical University of Lodz

    lead OTHER

Principal Investigators

  • Joanna Jerzynska, MD PhD · Department of Pediatrics and Allergy, Medical University of Lodz, Poland

  • Iwona Stelmach, MD PhD Prof · Department of Pediatrics and Allergy, Medical University of Lodz, Poland

  • Agnieszka Brzozowska, MD, PhD · Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2013-12-31
Completion
2014-06-30

Countries

  • Poland

Study Locations

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Entities

Drugs
Diseases

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 NCT00961155 on ClinicalTrials.gov