AsthmaAIRNCT01611012
The Development of a Clinical Test to Assess the Inflammatory Phenotype of Asthma
An observational study of Asthma, run by Prof. Jan-Willem Lammers MD PhD at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine the type and degree of inflammatory parameters in peripheral blood of asthma patients compared to analysis of induced sputum. 115 asthma patients visiting the outpatient clinic of the University Medical Center will be included. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- How many people
- 115 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2012to 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asthma patients between the age of 18 and 75, visiting outpatient respiratory clinic of the University Medical Centre in Utrecht, The Neterlands.
Who may be able to join
- Adult asthma
- Aged 18-75 years
- Visiting the outpatient clinic of the UMCU
Who cannot join
- Smoking at present or in the last 12 months
- Past smoking history of > 10 Pack years
- AB treatment for RTI in past 4 weeks
- ABPA
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the type and degree of inflammatory parameters in peripheral blood of asthma patients compared to analysis of induced sputum.
115 asthma patients visiting the outpatient clinic of the University Medical Center will be included. Blood samples are obtained and sputum induction is performed.
Hypothesis: in asthma the analysis of type and degree of inflammation in peripheral blood by changes in phenotypes of leukocytes is at least as reliable as analysis of cells obtained from induced sputum
Read the detailed description
Asthma is a heterogeneous disease and can be classified by level of control, disease severity and the inflammatory phenotype. However, these different domains overlap and classification of patients according to these characteristics has caused confusion in the literature. Concerning the inflammatory phenotype international consensus is present regarding the diagnostic power of induced sputum. This methodology is, however, difficult to implement in general practice. Local inflammation is associated with a complex combination of systemic pro- and anti-inflammatory signals that induce changes in responsive leukocytes. These changes can be used as read-out for type and degree of inflammatory disease. Hypothesis: This will facilitate the diagnosis of inflammatory phenotypes in asthma, as general application of induced sputum is not feasible.
Goals
- To investigate whether analysis of antibodies directed against active Beta-1 and Beta-2-integrins (CD29/CD18) and FcγRII (CD32) of primed eosinophils allows the diagnosis of eosinophilic asthma as compared to analysis of sputum eosinophilia.
- To evaluate the applicability of antibodies against active β1/β2-integrins and FcγRII in symptomatic asthma patients as a test to diagnose eosinophilic and neutrophilic asthma.
- To determine specific protein profiles in serum of asthma patients by proteomics for the development of a diagnostic test.
- To evaluate the effectiveness of this new test in comparison with FeNO.
- Conditions
- Asthma
- Keywords
- Asthma, Inflammation, Phenotype, Sputum
- Medical subject headings
- Asthma, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory phenotype
inflammatory phenotype in blood compared to type in sputum
Measured: 1 day
Secondary outcomes (3)
Measurement of antibodies against active β1/β2-integrins and FcγRII
Measured: 1 day
Measuring specific protein profiles in serum of asthma patients by proteomics
Measured: 1 day
FENO
Fraction of Exhaled Nitric Oxide
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Jan-Willem Lammers MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Jan-Willem Lammers MD PhD, UMC Utrecht
- Investigators
- Jan-Willem Lammers, MD, PhD, Principal investigator, Respiratory Department, UMC UtrechtLeo Koenderman, M.D. PhD, Study chair, Respiratory Department, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611012
- Sponsor's protocol ID
- AIR2012
- Acronym
- AIR
- Status last verified
- Jul 2014
- First submitted
- 25 May 2012
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kanters D, ten Hove W, Luijk B, van Aalst C, Schweizer RC, Lammers JW, Leufkens HG, Raaijmakers JA, Bracke M, Koenderman L. Expression of activated Fc gamma RII discriminates between multiple granulocyte-priming phenotypes in peripheral blood of allergic asthmatic subjects. J Allergy Clin Immunol. 2007 Nov;120(5):1073-81. doi: 10.1016/j.jaci.2007.06.021. Epub 2007 Aug 13.
PubMed 17697704Luijk B, Lindemans CA, Kanters D, van der Heijde R, Bertics P, Lammers JW, Bates ME, Koenderman L. Gradual increase in priming of human eosinophils during extravasation from peripheral blood to the airways in response to allergen challenge. J Allergy Clin Immunol. 2005 May;115(5):997-1003. doi: 10.1016/j.jaci.2005.02.002.
PubMed 15867857
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a Clinical Test to Assess the Inflammatory Phenotype of Asthma
- ClinicalTrials.gov ID
- NCT01611012
- Acronym / sponsor ID
- AIR / AIR2012
- Conditions
- Asthma
- Keywords
- Asthma, Inflammation, Phenotype, Sputum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Prof. Jan-Willem Lammers MD PhDUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Jun 2012 (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 purpose of this study is to determine the type and degree of inflammatory parameters in peripheral blood of asthma patients compared to analysis of induced sputum.
115 asthma patients visiting the outpatient clinic of the University Medical Center will be included. Blood samples are obtained and sputum induction is performed.
Hypothesis: in asthma the analysis of type and degree of inflammation in peripheral blood by changes in phenotypes of leukocytes is at least as reliable as analysis of cells obtained from induced sputum
Detailed description
Asthma is a heterogeneous disease and can be classified by level of control, disease severity and the inflammatory phenotype. However, these different domains overlap and classification of patients according to these characteristics has caused confusion in the literature. Concerning the inflammatory phenotype international consensus is present regarding the diagnostic power of induced sputum. This methodology is, however, difficult to implement in general practice. Local inflammation is associated with a complex combination of systemic pro- and anti-inflammatory signals that induce changes in responsive leukocytes. These changes can be used as read-out for type and degree of inflammatory disease. Hypothesis: This will facilitate the diagnosis of inflammatory phenotypes in asthma, as general application of induced sputum is not feasible.
Goals
- To investigate whether analysis of antibodies directed against active Beta-1 and Beta-2-integrins (CD29/CD18) and FcγRII (CD32) of primed eosinophils allows the diagnosis of eosinophilic asthma as compared to analysis of sputum eosinophilia.
- To evaluate the applicability of antibodies against active β1/β2-integrins and FcγRII in symptomatic asthma patients as a test to diagnose eosinophilic and neutrophilic asthma.
- To determine specific protein profiles in serum of asthma patients by proteomics for the development of a diagnostic test.
- To evaluate the effectiveness of this new test in comparison with FeNO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthma patients between the age of 18 and 75, visiting outpatient respiratory clinic of the University Medical Centre in Utrecht, The Neterlands.
Key inclusion criteria (3 listed)
- Adult asthma
- Aged 18-75 years
- Visiting the outpatient clinic of the UMCU
Key exclusion criteria (4 listed)
- Smoking at present or in the last 12 months
- Past smoking history of > 10 Pack years
- AB treatment for RTI in past 4 weeks
- ABPA
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
inflammatory phenotype
Time frame: 1 day
inflammatory phenotype in blood compared to type in sputum
3 secondary outcomes
Measurement of antibodies against active β1/β2-integrins and FcγRII
Time frame: 1 day
Measuring specific protein profiles in serum of asthma patients by proteomics
Time frame: 1 day
FENO
Time frame: 1 day
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 3 Jul 2014.
- Background: PubMed 17697704Kanters D, ten Hove W, Luijk B, van Aalst C, Schweizer RC, Lammers JW, Leufkens HG, Raaijmakers JA, Bracke M, Koenderman L. Expression of activated Fc gamma RII discriminates between multiple granulocyte-priming phenotypes in peripheral blood of allergic asthmatic subjects. J Allergy Clin Immunol. 2007 Nov;120(5):1073-81. doi: 10.1016/j.jaci.2007.06.021. Epub 2007 Aug 13.
- Background: PubMed 15867857Luijk B, Lindemans CA, Kanters D, van der Heijde R, Bertics P, Lammers JW, Bates ME, Koenderman L. Gradual increase in priming of human eosinophils during extravasation from peripheral blood to the airways in response to allergen challenge. J Allergy Clin Immunol. 2005 May;115(5):997-1003. doi: 10.1016/j.jaci.2005.02.002.
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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.
Jan-Willem Lammers, MD, PhD principal investigator
Respiratory Department, UMC Utrecht
Leo Koenderman, M.D. PhD study chair
Respiratory Department, UMC Utrecht
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, run by Prof. Jan-Willem Lammers MD PhD 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 3 inclusion and 4 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 3 Jul 2014. 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?
inflammatory phenotype (time frame: 1 day). 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 NCT01611012, which also lists 2 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 3 Jul 2014.