Standardisation of Measurements in Exhaled Breath and Exhaled Breath Condensate.

Asthma Clinical Trial

Official title:

Optimising and Standardising Measurements of Inflammatory Markers in Exhaled Breath (EB) and Exhaled Breath Condensate (EBC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00983671
• Other study ID #: MEC 09-2-080
• Secondary ID: NL25969.068.09
• Status: Recruiting
• Phase: N/A
• First received: September 17, 2009
• Last updated: July 21, 2011
• Start date: February 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2011
• Source: Maastricht University Medical Center
• Contact: M.D. Ottink, MD
• Phone: +31-43-3877248
• Email: m.ottink[@]mumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

Background: in various pediatric pulmonary diseases such as asthma, cystic fibrosis or bronchopulmonary dysplasia an increased inflammation is present. Measuring this inflammation is often hardly possible and requires invasive techniques such as bronchoscopy.

With the use of exhaled breath condensate (EBC) or exhaled breath (EB) analysis it is possible to measure the inflammation in an non-invasive way. However, there is a great need to further standardise these measurements and to identify possible confounding factors.

Description:

Background of the study:

Measurement of inflammatory markers (IM) in exhaled breath and exhaled breath condensate (EB(C)) is a very interesting and useful non-invasive new technique to evaluate airway inflammation. This technique is helpful for diagnostic and monitoring purposes in both children and adults with chronic lung disease. The hypothesis of the present study is that standardisation not only increase the reproducibility of measurements but will also enlarge the possibility to detect differences between healthy and diseased subjects.

Objective of the study:

1. to investigate the influence of various factors on the concentration of markers in EB(C); parameters on a subject level (e.g. breathing pattern, nose clip, inspiratory filter, saliva contamination, physical exertion), on an apparatus level (cleaning procedures, temperature of the condenser tube, environmental conditions, buffer bags), and on a measurement/analysis level (sampling time, storage time, storage temperature, protein inhibitor or bovine serum albumine) can be discriminated.

2. to assess whether the reproducibility of measurements in EB(C) can be increased by analysing with ellipsometry, lyophilization or by standardising for exhaled volume, sampling time, or dilution factor.

3. to investigate whether differences in inflammatory markers (IM) in EBC between healthy and diseased subjects will increase by specific EB(C) sampling from more distal airways. Children with asthma, cystic fibrosis (CF), primary ciliary dyskinesia (PCD), bronchopulmonary dysplasia (BPD), and lower respiratory tract infections (LRTI) will be included.

Study design:

Part I: Cross-sectional study assessing the random influence of presence or absence of various factors on the concentration of IM in EB(C); Part II: A short-term prospective study on reproducibility during five consecutive days; Part III: A cross-sectional comparative study in several groups of children (healthy, asthma, CF, PCD, BPD, LRTI);

Study population:

Study part I and II are performed in healthy adult volunteers. Study part III is performed in healthy children and in children with asthma, CF, PCD, BPD, and LRTI aged 2-16 years.

Primary study parameters/outcome of the study:

Study part I: Concentration of IM in EB(C). Study part II: Reproducibility as assessed by coefficients of variations of IM in EB(C).

Study part III: Concentration of IM in EB(C) from more distal and more proximal airways.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

study part I and II:

• healthy adults, 18-50 years study part III:

• healthy children age 6-18 years

• patients with cystic fibrosis

• patients with asthma

• patients with chronic lung disease

• patients with pneumonia, all age 6-18 years

Exclusion Criteria:

Study part I and II:

• Subjects with a history of atopy or respiratory disease, as indicated by the ISAAC questionnaire.

Study part III:

• Mental retardation

• active smoking

• heart disease

• syndromes

• congenital malformations of the airways

• inability to perform the measurements

• for patients with lower respiratory tract infection: oxygen need, asthma or other chronic lung disease, active or passive smoking, inability to perform the measurements.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Asthma
• Chronic Lung Disease
• Cystic Fibrosis
• Lung Diseases
• Pneumonia

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre, Pediatric Pulmonology	Maastricht	Po Box 5800

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study I: concentration of inflammatory markers in EB(C)		1 week	No
Primary	Study II: Reproducibility of inflammatory markers in EB(C)		1 week	No
Primary	Study III: concentration of inflammatory markers in EB(C) of the proximal and distal airways		1 week	No