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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Jan-Willem Lammers MD PhD, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01611012
First received: May 25, 2012
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Development of a Clinical Test to Assess the Inflammatory Phenotype of Asthma

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • inflammatory phenotype [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    inflammatory phenotype in blood compared to type in sputum


Secondary Outcome Measures:
  • Measurement of antibodies against active β1/β2-integrins and FcγRII [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Measuring specific protein profiles in serum of asthma patients by proteomics [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • FENO [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Fraction of Exhaled Nitric Oxide


Biospecimen Retention:   Samples Without DNA

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


Enrollment: 115
Study Start Date: May 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611012

Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Prof. Jan-Willem Lammers MD PhD, M.D. PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01611012     History of Changes
Other Study ID Numbers: AIR2012
Study First Received: May 25, 2012
Last Updated: July 2, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Asthma
Inflammation
Phenotype
Sputum

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014