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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Medical Universtity of Lodz
Sponsor:
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00961155
First received: August 17, 2009
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: cyklezonid
Drug: montelukast sodium
Drug: placebo
Drug: formoterol 12 mcg twice daily
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Usefulness of Exhaled Breath Condensate and FENO for Evaluation of Markers of Airway Inflammation in Children With Asthma

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

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. [ Time Frame: visit 1-6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measurement of FENO, bronchial hyperreactivity, exercise treadmill challenge, lung function and clinical evaluation [ Time Frame: visits 1-6 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: August 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cyklezonid
children will receive 160 mcg once daily cyklezonid for 3 months
Drug: cyklezonid
160 mcg once daily
Other Name: Alvesco
Active Comparator: montelukast sodium
children will receive 5 or 10 mg montelukast sodium for 3 months
Drug: montelukast sodium
5 or 10 mg according to age once daily
Placebo Comparator: placebo
children will receive placebo for 8 weeks out of allergy season to house dust mite
Drug: placebo
fluticasone placebo twice daily, montelukast placebo once daily
Active Comparator: formoterol
children will receive formoterol aerolzol 12mcg twice daily for 3 months
Drug: formoterol 12 mcg twice daily
formoterol 12 mcg twice daily will be given to children for 3 months
Other Name: Formoterol

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961155

Contacts
Contact: Joanna Jerzynska, MD PhD 0048607153123 joannajerzynska@gmail.com
Contact: Iwona Stelmach, MD PhD Prof 0048426895972

Locations
Poland
Department of Pediatrics and Allergy, Medical University of Lodz, Poland Recruiting
Lodz, Poland
Contact: Joanna Jerzynska, MD PhD    0048607153123    joannajerzynska@gmail.com   
Sub-Investigator: Joanna Jerzynska, MD PhD         
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
Principal Investigator: Joanna Jerzynska, MD PhD Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Study Chair: Iwona Stelmach, MD PhD Prof Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Principal Investigator: Agnieszka Brzozowska, MD, PhD Department of Pediatrics and Allergy, Medical University of Lodz, Poland
  More Information

No publications provided

Responsible Party: Iwona Stelmach, MD, PhD, Professor, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT00961155     History of Changes
Other Study ID Numbers: RNN/137/08/KE
Study First Received: August 17, 2009
Last Updated: December 9, 2013
Health Authority: Poland: Ministry of Health

Keywords provided by Medical Universtity of Lodz:
asthma
children
EBC
exposure to tabacco
antiasthma treatment

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Formoterol
Montelukast
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014