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

NCT01611012 | Completed

• 1 other identifier: AIR2012
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Asthma

Keywords

Asthma; Inflammation; Phenotype; Sputum

Outcome Measures

Primary Outcomes (1)

• inflammatory phenotype

  inflammatory phenotype in blood compared to type in sputum

  1 day

Secondary Outcomes (3)

• 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

  1 day

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult asthma
• Aged 18-75 years
• Visiting the outpatient clinic of the UMCU

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Jan-Willem Lammers MD PhD: lead

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3584CX, Netherlands

Location

Related 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. doi: 10.1016/j.jaci.2007.06.021. Epub 2007 Aug 13.

  PMID: 17697704 BACKGROUND

• 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.

  PMID: 15867857 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Leukocytes in peripheral blood, serum samples for protein profiling and sputum samples.

MeSH Terms

Conditions

Asthma; Inflammation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan-Willem Lammers, MD, PhD

  Respiratory Department, UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Leo Koenderman, M.D. PhD

  Respiratory Department, UMC Utrecht

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D. PhD

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: June 4, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 3, 2014

Record last verified: 2014-07

Locations

NL (1)