NCT00500253

Brief 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. 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. 2.Assessment of corelation of FeNO (ppb) with symptom score (points)and lung function (FEV1)
  3. 3.Comparison of values of non-specific bronchial hyperresponsiveness with methacholine (PC20M)between both study groups after 12. months of treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

6.8 years

First QC Date

July 11, 2007

Last Update Submit

February 6, 2013

Conditions

Asthma

Keywords

exhaled nitric oxideasthmachildreninhaled glucocorticosteroids

Outcome Measures

Primary Outcomes (1)

  • Control of the disease

    1 year

Study Arms (2)

1

ACTIVE COMPARATOR

children with asthma with FeNO monitored treatment (study group)

Device: exhaled nitric oxide measurementProcedure: bronchial hyperresponsiveness with methacholine (PC20M)

2

OTHER

group of children with treatment monitored by GINA's grade of disease clinical control (control group)

Procedure: bronchial hyperresponsiveness with methacholine (PC20M)Procedure: symptom score diary (according to 2007 GINA guidelines)

Interventions

exhaled nitric oxide measurementDEVICE

exhaled nitric oxide measurement

Also known as: exhaled nitric oxide measurement (Sievers FeNO analyzer)
1
bronchial hyperresponsiveness with methacholine (PC20M)PROCEDURE

bronchial hyperresponsiveness with methacholine (PC20M)

Also known as: PC20M Jaeger APS system
12
symptom score diary (according to 2007 GINA guidelines)PROCEDURE

symptom score diary (according to 2007 GINA guidelines)

2

Eligibility Criteria

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

You may qualify if:

  • FeNO values above the norm for age and inadequate asthma control (based GINA guidelines)

You may not qualify if:

  • presence of other perennial and seasonal allergies
  • presence of other chronic diseases
  • excluded medications: systemic glucocorticosteroids 3 months before enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland

Lodz, 93-513, Poland

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Methacholine Chloride

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Methacholine CompoundsTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Anna Sołoniewicz, MD

    Department of Pediatrics and Allergy, Medical University of Lodz, Poland

    PRINCIPAL INVESTIGATOR

  • Iwona Stelmach, MD, PhD, Prof

    Department of Pediatrics and Allergy, Medical University of Lodz, Poland

    STUDY CHAIR

Central Study Contacts

Anna Sołoniewicz, MD

CONTACT

00 48 42 6895972alergol@kopernik.lodz.pl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 12, 2007

Study Start

February 1, 2007

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

PL(1)