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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00961155
• Other study ID #: RNN/137/08/KE
• Status: Recruiting
• Phase: Phase 2
• First received: August 17, 2009
• Last updated: December 9, 2013
• Start date: August 2009
• Est. completion date: June 2014

Study information

• Verified date: December 2013
• Source: Medical Universtity of Lodz
• Contact: Joanna Jerzynska, MD PhD
• Phone: 0048607153123
• Email: joannajerzynska[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• cyklezonid
160 mcg once daily
• montelukast sodium
5 or 10 mg according to age once daily
• placebo
fluticasone placebo twice daily, montelukast placebo once daily
• formoterol 12 mcg twice daily
formoterol 12 mcg twice daily will be given to children for 3 months

Locations

Country	Name	City	State
Poland	Department of Pediatrics and Allergy, Medical University of Lodz, Poland	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		visit 1-6	Yes
Secondary	Measurement of FENO, bronchial hyperreactivity, exercise treadmill challenge, lung function and clinical evaluation		visits 1-6	Yes