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

NCT ID: NCT00961155

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Markers that can be identified in the EBC of patients with asthma include pH, hydrogen peroxide, nitrogen oxides, eicosanoids, isoprostanes, adenosine, certain cytokines, chemokines, and growth factors. Concentrations of these biomarkers are influenced by inflammation, oxidative stress, and can be modulated by therapeutic interventions. There is evidence that some markers in EBC differ between patients with asthma and controls, and some of them can correlate with asthma severity score, lung function. 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. We will also evaluate the effect of antiasthmatic treatment applied out of dust season on the number of exacerbations in "asthma epidemic" in September. We will evaluate the effect of exposure to tobacco smoke on antiasthmatic treatment.

Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction (EIB) as another phenotype of asthma. At the first study vist patients with EIB underwent fractional exhaled nitric oxide measurement (FeNO) and baseline spirometry, performed exercise treadmill challenge (ETC) and EBC samples were obtained at the end of ETC.

Conditions

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Asthma

Keywords

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asthma children EBC exposure to tabacco antiasthma treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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cyklezonid

children will receive 160 mcg once daily cyklezonid for 3 months

Group Type ACTIVE_COMPARATOR

cyklezonid

Intervention Type DRUG

160 mcg once daily

montelukast sodium

children will receive 5 or 10 mg montelukast sodium for 3 months

Group Type ACTIVE_COMPARATOR

montelukast sodium

Intervention Type DRUG

5 or 10 mg according to age once daily

placebo

children will receive placebo for 8 weeks out of allergy season to house dust mite

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

fluticasone placebo twice daily, montelukast placebo once daily

formoterol

children will receive formoterol aerolzol 12mcg twice daily for 3 months

Group Type ACTIVE_COMPARATOR

formoterol 12 mcg twice daily

Intervention Type DRUG

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

Interventions

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cyklezonid

160 mcg once daily

Intervention Type DRUG

montelukast sodium

5 or 10 mg according to age once daily

Intervention Type DRUG

placebo

fluticasone placebo twice daily, montelukast placebo once daily

Intervention Type DRUG

formoterol 12 mcg twice daily

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

Intervention Type DRUG

Other Intervention Names

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Alvesco Formoterol

Eligibility Criteria

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Inclusion Criteria

* children with mild to moderate asthma allergic to house dust mite exposed/nonexposed to tobacco smoke
* healthy children

Exclusion Criteria

* sensitization to allergens other than house dust mites
* other chronic diseases
* asthma exacerbation
* pregnancy
* oral corticosteroids for 4 weeks before the study
* montelukast sodium for 2 weeks before the study
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

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Iwona Stelmach

MD, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joanna Jerzynska, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Iwona Stelmach, MD PhD Prof

Role: STUDY_CHAIR

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

Agnieszka Brzozowska, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Lodz, Łódź Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Joanna Jerzynska, MD PhD

Role: CONTACT

Phone: 0048607153123

Email: [email protected]

Iwona Stelmach, MD PhD Prof

Role: CONTACT

Phone: 0048426895972

Facility Contacts

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Joanna Jerzynska, MD PhD

Role: primary

Other Identifiers

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RNN/137/08/KE

Identifier Type: -

Identifier Source: org_study_id