AsthmaNCT00983671
Standardisation of Measurements in Exhaled Breath and Exhaled Breath Condensate.
An observational study of Asthma and Cystic Fibrosis, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Cystic Fibrosis, Chronic Lung Disease
- How many people
- 255 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: For study I and II: community sample For study III: healthy children recruited at a primary school, children with asthma, cystic fibrosis, chronic lung disease or pneumonia, recruited from the outpatient clinic of pediatric pulmonology
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Centre, Pediatric Pulmonology
Maastricht, Po Box 5800, 6202 AZ
M.D. Ottink, MD
About this study
Official title: Optimising and Standardising Measurements of Inflammatory Markers in Exhaled Breath (EB) and Exhaled Breath Condensate (EBC)
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.
Read the detailed 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:
- 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.
- 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.
- 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.
- Conditions
- Asthma, Cystic Fibrosis, Chronic Lung Disease, Pneumonia
- Keywords
- Asthma, cystic fibrosis, chronic lung disease, bronchopulmonary dysplasia, pneumonia
- Medical subject headings
- Asthma, Cystic Fibrosis, Pneumonia, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children with asthma | children with diagnosed asthma, age 6-18 years | |
| cystic fibrosis | children with cystic fibrosis, age 6-18 years | |
| chronic lung disease | children with chronic lung disease, also known as bronchopulmonary dysplasia, age 6-18 years | |
| pneumonia | children with clinical signs of pneumonia, age 6-18 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study I: concentration of inflammatory markers in EB(C)
Measured: 1 week
Study II: Reproducibility of inflammatory markers in EB(C)
Measured: 1 week
Study III: concentration of inflammatory markers in EB(C) of the proximal and distal airways
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startFeb 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- E. Dompeling, PhD, Study director, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983671
- Sponsor's protocol ID
- MEC 09-2-080
- Other IDs
- NL25969.068.09
- Status last verified
- Jul 2011
- First submitted
- 17 Sep 2009
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising and Standardising Measurements of Inflammatory Markers in Exhaled Breath (EB) and Exhaled Breath Condensate (EBC)
- ClinicalTrials.gov ID
- NCT00983671
- Acronym / sponsor ID
- MEC 09-2-080
- Conditions
- Asthma, Cystic Fibrosis, Chronic Lung Disease, Pneumonia
- Keywords
- Asthma, cystic fibrosis, chronic lung disease, bronchopulmonary dysplasia, pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 24 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| children with asthma | – | –children with diagnosed asthma, age 6-18 years |
| cystic fibrosis | – | –children with cystic fibrosis, age 6-18 years |
| chronic lung disease | – | –children with chronic lung disease, also known as bronchopulmonary dysplasia, age 6-18 years |
| pneumonia | – | –children with clinical signs of pneumonia, age 6-18 years |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- For study I and II: community sample For study III: healthy children recruited at a primary school, children with asthma, cystic fibrosis, chronic lung disease or pneumonia, recruited from the outpatient clinic of pediatric pulmonology
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Subjects with a history of atopy or respiratory disease, as indicated by the ISAAC questionnaire.
- Mental retardation
- active smoking
- heart disease
- syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study I: concentration of inflammatory markers in EB(C)
Time frame: 1 week
Study II: Reproducibility of inflammatory markers in EB(C)
Time frame: 1 week
Study III: concentration of inflammatory markers in EB(C) of the proximal and distal airways
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E. Dompeling, PhD study director
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Cystic Fibrosis, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M.D. Ottink, MD (+31-43-3877248, m.ottink@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study I: concentration of inflammatory markers in EB(C) (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2011.