AsthmaNCT00422747
Early Diagnosis of Asthma in Young Children
A study testing beclomethasondipropionate in people with Asthma, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The overall aim of the study is an early asthma diagnosis in young children by the use of non-invasive biomarkers of airway inflammation /oxidative stress in exhaled air, and early lung function measurements Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- beclomethasondipropionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2007to Aug 2012
- Phase
- Interventional
- 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 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 2-3 years, with recurrent respiratory symptoms suggestive of asthma
- Children aged 2-3 years, with no or minor respiratory symptoms
Who cannot join
- Mental retardation
- Cardiac anomalies
- Congenital malformations
- Other diseases of the lungs/airways
- Chronic systemic inflammatory diseases like M. Crohn
- The inability to perform lung function measurements and/or exhaled air collection
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 5800
About this study
The overall aim of the study is an early asthma diagnosis in young children by the use of non-invasive biomarkers of airway inflammation /oxidative stress in exhaled air, and early lung function measurements
- Conditions
- Asthma
- Being tested
- beclomethasondipropionate
- Keywords
- asthma, transient wheezing, early diagnosis, exhaled air, nitrogen monoxide, airway resistance
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beclomethasondipropionateDrug
Also called Qvar Extra Fijn
2 x 100 ug dd for two months, via aerochamber
| Study group | Role | What they receive |
|---|---|---|
| beclomethasondipropionate | Experimental | 2 x 100 ug dd for two months, via aerochamber Receives: Drug: beclomethasondipropionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
- definite asthma diagnosis - biomarkers in exhaled breath
Measured: 6 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startApr 2007
- Primary completionJun 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Asthma Foundation, Stichting Astma Bestrijding, The Netherlands
- Responsible party
- Sponsor
- Investigators
- Edward Dompeling, PhD MD, Principal investigator, Dept. of Paediatric Pulmonology, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422747
- Sponsor's protocol ID
- NL17407.000.07/2007-001817-40
- Status last verified
- Jun 2013
- First submitted
- 15 Jan 2007
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Klaassen EM, van de Kant KD, Jobsis Q, van Schayck OC, Smolinska A, Dallinga JW, van Schooten FJ, den Hartog GJ, de Jongste JC, Rijkers GT, Dompeling E. Exhaled biomarkers and gene expression at preschool age improve asthma prediction at 6 years of age. Am J Respir Crit Care Med. 2015 Jan 15;191(2):201-7. doi: 10.1164/rccm.201408-1537OC.
PubMed 25474185van de Kant KD, van Berkel JJ, Jobsis Q, Lima Passos V, Klaassen EM, van der Sande L, van Schayck OC, de Jongste JC, van Schooten FJ, Derks E, Dompeling E, Dallinga JW. Exhaled breath profiling in diagnosing wheezy preschool children. Eur Respir J. 2013 Jan;41(1):183-8. doi: 10.1183/09031936.00122411.
PubMed 23277518van de Kant KD, Koers K, Rijkers GT, Lima Passos V, Klaassen EM, Mommers M, Dagnelie PC, van Schayck CP, Dompeling E, Jobsis Q. Can exhaled inflammatory markers predict a steroid response in wheezing preschool children? Clin Exp Allergy. 2011 Aug;41(8):1076-83. doi: 10.1111/j.1365-2222.2011.03774.x. Epub 2011 May 30.
PubMed 21623968van de Kant KD, Klaassen EM, Jobsis Q, Nijhuis AJ, van Schayck OC, Dompeling E. Early diagnosis of asthma in young children by using non-invasive biomarkers of airway inflammation and early lung function measurements: study protocol of a case-control study. BMC Public Health. 2009 Jun 29;9:210. doi: 10.1186/1471-2458-9-210.
PubMed 19563637
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Asthma in Young Children
- ClinicalTrials.gov ID
- NCT00422747
- Acronym / sponsor ID
- NL17407.000.07/2007-001817-40
- Conditions
- Asthma
- Keywords
- asthma, transient wheezing, early diagnosis, exhaled air, nitrogen monoxide, airway resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- The Netherlands Asthma Foundation, Stichting Astma Bestrijding, The Netherlands
- Study start
- Apr 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Jan 2007 (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.
The overall aim of the study is an early asthma diagnosis in young children by the use of non-invasive biomarkers of airway inflammation /oxidative stress in exhaled air, and early lung function measurements
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| beclomethasondipropionate | Experimental | Drug: beclomethasondipropionate2 x 100 ug dd for two months, via aerochamber |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 2-3 years, with recurrent respiratory symptoms suggestive of asthma
- Children aged 2-3 years, with no or minor respiratory symptoms
Key exclusion criteria (6 listed)
- Mental retardation
- Cardiac anomalies
- Congenital malformations
- Other diseases of the lungs/airways
- Chronic systemic inflammatory diseases like M. Crohn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beclomethasondipropionateAlso: Qvar Extra Fijn2 x 100 ug dd for two months, via aerochamber | Drug | beclomethasondipropionate |
Primary outcome
- definite asthma diagnosis - biomarkers in exhaled breath
Time frame: 6 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
- Derived from this study: PubMed 25474185Klaassen EM, van de Kant KD, Jobsis Q, van Schayck OC, Smolinska A, Dallinga JW, van Schooten FJ, den Hartog GJ, de Jongste JC, Rijkers GT, Dompeling E. Exhaled biomarkers and gene expression at preschool age improve asthma prediction at 6 years of age. Am J Respir Crit Care Med. 2015 Jan 15;191(2):201-7. doi: 10.1164/rccm.201408-1537OC.
- Derived from this study: PubMed 23277518van de Kant KD, van Berkel JJ, Jobsis Q, Lima Passos V, Klaassen EM, van der Sande L, van Schayck OC, de Jongste JC, van Schooten FJ, Derks E, Dompeling E, Dallinga JW. Exhaled breath profiling in diagnosing wheezy preschool children. Eur Respir J. 2013 Jan;41(1):183-8. doi: 10.1183/09031936.00122411.
- Derived from this study: PubMed 21623968van de Kant KD, Koers K, Rijkers GT, Lima Passos V, Klaassen EM, Mommers M, Dagnelie PC, van Schayck CP, Dompeling E, Jobsis Q. Can exhaled inflammatory markers predict a steroid response in wheezing preschool children? Clin Exp Allergy. 2011 Aug;41(8):1076-83. doi: 10.1111/j.1365-2222.2011.03774.x. Epub 2011 May 30.
- Derived from this study: PubMed 19563637van de Kant KD, Klaassen EM, Jobsis Q, Nijhuis AJ, van Schayck OC, Dompeling E. Early diagnosis of asthma in young children by using non-invasive biomarkers of airway inflammation and early lung function measurements: study protocol of a case-control study. BMC Public Health. 2009 Jun 29;9:210. doi: 10.1186/1471-2458-9-210.
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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.
Edward Dompeling, PhD MD principal investigator
Dept. of Paediatric Pulmonology, 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?
A study testing beclomethasondipropionate in people with Asthma, 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 18 Jun 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- definite asthma diagnosis - biomarkers in exhaled breath (time frame: 6 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00422747, which also lists 4 linked publications.
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 18 Jun 2013.