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

Primary Purpose

Asthma

Status
Unknown status
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
cyklezonid
montelukast sodium
placebo
formoterol 12 mcg twice daily
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, children, EBC, exposure to tabacco, antiasthma treatment

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Pediatrics and Allergy, Medical University of Lodz, PolandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

cyklezonid

montelukast sodium

placebo

formoterol

Arm Description

children will receive 160 mcg once daily cyklezonid for 3 months

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

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

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

Outcomes

Primary Outcome Measures

Measurement of IL-4, 5, 6, 8, 16, MIG, TNF- alpha, MCP-1 in EBC. Measurement of ECP, eosinophil blood count, cotinine and total IgE in blood.

Secondary Outcome Measures

Measurement of FENO, bronchial hyperreactivity, exercise treadmill challenge, lung function and clinical evaluation

Full Information

First Posted
August 17, 2009
Last Updated
December 9, 2013
Sponsor
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT00961155
Brief Title
Usefulness of Exhaled Breath Condensate for Evaluation of Markers of Airway Inflammation in Children With Asthma
Official Title
Usefulness of Exhaled Breath Condensate and FENO for Evaluation of Markers of Airway Inflammation in Children With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lodz

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, children, EBC, exposure to tabacco, antiasthma treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cyklezonid
Arm Type
Active Comparator
Arm Description
children will receive 160 mcg once daily cyklezonid for 3 months
Arm Title
montelukast sodium
Arm Type
Active Comparator
Arm Description
children will receive 5 or 10 mg montelukast sodium for 3 months
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
children will receive placebo for 8 weeks out of allergy season to house dust mite
Arm Title
formoterol
Arm Type
Active Comparator
Arm Description
children will receive formoterol aerolzol 12mcg twice daily for 3 months
Intervention Type
Drug
Intervention Name(s)
cyklezonid
Other Intervention Name(s)
Alvesco
Intervention Description
160 mcg once daily
Intervention Type
Drug
Intervention Name(s)
montelukast sodium
Intervention Description
5 or 10 mg according to age once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
fluticasone placebo twice daily, montelukast placebo once daily
Intervention Type
Drug
Intervention Name(s)
formoterol 12 mcg twice daily
Other Intervention Name(s)
Formoterol
Intervention Description
formoterol 12 mcg twice daily will be given to children for 3 months
Primary Outcome Measure Information:
Title
Measurement of IL-4, 5, 6, 8, 16, MIG, TNF- alpha, MCP-1 in EBC. Measurement of ECP, eosinophil blood count, cotinine and total IgE in blood.
Time Frame
visit 1-6
Secondary Outcome Measure Information:
Title
Measurement of FENO, bronchial hyperreactivity, exercise treadmill challenge, lung function and clinical evaluation
Time Frame
visits 1-6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanna Jerzynska, MD PhD
Phone
0048607153123
Email
joannajerzynska@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Iwona Stelmach, MD PhD Prof
Phone
0048426895972
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Jerzynska, MD PhD
Organizational Affiliation
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Iwona Stelmach, MD PhD Prof
Organizational Affiliation
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Agnieszka Brzozowska, MD, PhD
Organizational Affiliation
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
City
Lodz
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Jerzynska, MD PhD
Phone
0048607153123
Email
joannajerzynska@gmail.com
First Name & Middle Initial & Last Name & Degree
Joanna Jerzynska, MD PhD

12. IPD Sharing Statement

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

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