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

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

Study Overview

• Status: Completed
• Conditions: Asthma

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

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.

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584CX
    • UMC Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Asthma patients between the age of 18 and 75, visiting outpatient respiratory clinic of the University Medical Centre in Utrecht, The Neterlands.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammatory phenotype	inflammatory phenotype in blood compared to type in sputum	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of antibodies against active β1/β2-integrins and FcγRII		1 day
Measuring specific protein profiles in serum of asthma patients by proteomics		1 day
FENO	Fraction of Exhaled Nitric Oxide	1 day

Collaborators and Investigators

• Sponsor: Prof. Jan-Willem Lammers MD PhD
• Investigators: Principal Investigator: Jan-Willem Lammers, MD, PhD, Respiratory Department, UMC Utrecht; Study Chair: Leo Koenderman, M.D. PhD, Respiratory Department, UMC Utrecht

Publications and helpful links

General 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.
• 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. doi: 10.1016/j.jaci.2005.02.002.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 25, 2012
• First Submitted That Met QC Criteria: June 1, 2012
• First Posted (Estimate): June 4, 2012

Study Record Updates

• Last Update Posted (Estimate): July 3, 2014
• Last Update Submitted That Met QC Criteria: July 2, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Inflammation; Asthma; Phenotype; Sputum
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: AIR2012