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Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma

NCT00500253 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-02-07

No results posted yet for this study

Summary

The aim of this study is to assess the utility of exhaled nitric oxide measurement (FeNO) in treatment monitoring in children with asthma.

According to the aim of the study following assumptions are formulated:

1. Comparison of annual cumulative steroid dose, number of bronchodilator doses taken, number of asthma exacerbation, number of hospitalisation due to asthma, between group of children with asthma with FeNO monitored treatment (study group), and group of children with treatment monitored by GINA's grade of disease clinical control (control group)
2. Assessment of corelation of FeNO (ppb) with symptom score (points)and lung function (FEV1)
3. Comparison of values of non-specific bronchial hyperresponsiveness with methacholine (PC20M)between both study groups after 12. months of treatment.

Conditions

Interventions

DEVICE

exhaled nitric oxide measurement

exhaled nitric oxide measurement

PROCEDURE

bronchial hyperresponsiveness with methacholine (PC20M)

bronchial hyperresponsiveness with methacholine (PC20M)

PROCEDURE

symptom score diary (according to 2007 GINA guidelines)

symptom score diary (according to 2007 GINA guidelines)

Sponsors & Collaborators

  • Medical University of Lodz

    lead OTHER

Principal Investigators

  • Anna Sołoniewicz, MD · 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

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2013-11-30
Completion
2013-12-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

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 NCT00500253 on ClinicalTrials.gov