The Development of a Clinical Test to Assess the Inflammatory Phenotype of Asthma

Asthma Clinical Trial

— AIR  

Official title:

The Development of a Clinical Test to Assess the Inflammatory Phenotype of Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611012
• Other study ID #: AIR2012
• Status: Completed
• Phase: N/A
• First received: May 25, 2012
• Last updated: July 2, 2014
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical 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. 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

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

1. 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.

2. 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.

3. To determine specific protein profiles in serum of asthma patients by proteomics for the development of a diagnostic test.

4. To evaluate the effectiveness of this new test in comparison with FeNO.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adult asthma

• Aged 18-75 years

• Visiting the outpatient clinic of the UMCU

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Jan-Willem Lammers MD PhD

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. Epub 2007 Aug 13. — View Citation

Luijk 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory phenotype	inflammatory phenotype in blood compared to type in sputum	1 day	No
Secondary	Measurement of antibodies against active ß1/ß2-integrins and Fc?RII		1 day	No
Secondary	Measuring specific protein profiles in serum of asthma patients by proteomics		1 day	No
Secondary	FENO	Fraction of Exhaled Nitric Oxide	1 day	No