Analysis of Blood-based Biomarkers of Asthma (ABBA)

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
John V. Fahy, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00917787
First received: June 8, 2009
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to analyze markers of inflammation in blood and in induced sputum for the purpose of identifying molecular markers of specific asthma phenotypes. The investigators' specific interest is demonstrating that periostin levels are higher than normal in blood. The investigators already have solid preliminary data to support this hypothesis, and our goal here is to replicate preliminary findings and extend them by examining further the characteristics of the asthma subgroup with elevated periostin levels.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Analysis of Blood-based Biomarkers of Asthma

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • periostin levels in blood [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

sputum, saliva, DNA, RNA, Plasma, serum


Enrollment: 127
Study Start Date: June 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy, Non-asthmatic
Asthma

Detailed Description:

This is a cross-sectional study in patients with asthma and healthy controls in which we will analyze markers of inflammation in blood and in induced sputum for the purpose of identifying molecular markers of specific asthma phenotypes. Our specific interest in demonstrating that periostin levels are higher than normal in blood. We already have solid preliminary data to support this hypothesis, and our goal here is to replicate preliminary findings and extend them by examining further the characteristics of the asthma subgroup with elevated periostin levels. In this regard, we propose detailed phenotyping of the asthmatic subjects and the healthy controls, including measures in induced sputum, exhaled air and detailed physiologic measures including measures of airflow, lung volumes, and methacholine responsiveness. In earlier work we have found that periostin is a marker of Th-2 driven asthma, and we will use the data collected here to further explore this possibility. The biospecimens collected here will also allow us to expand existing plasma, DNA, RNA, and sputum samples in the UCSF Airway tissue bank, so that we can continue to build this resource for future research questions.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Asthmatics and Non-asthmatics

Criteria

Asthmatic Subjects Inclusion criteria

  1. Male and female subjects between the ages of 18 and 70 years with a history of asthma who may or may not be taking inhaled corticosteroids for asthma control.
  2. Physician diagnosis of asthma
  3. PC20FEV1 methacholine ≤ 8.0 mg/mL, except for those taking daily inhaled corticosteroids, for which the PC20 methacholine should be < 16 mg/mL.
  4. Ability to provide informed consent.

Healthy Subjects Inclusion criteria

  1. Healthy male and female subjects with no history of asthma between the ages of 18 and 70 years. Subjects should not be taking inhaled or oral corticosteroids.
  2. No lifetime history of asthma or allergic rhinitis.
  3. Ability to provide informed consent.

Exclusion Criteria for both subject groups

  1. Lung disease other than asthma.
  2. History of an upper or lower respiratory tract infection in the 4 weeks preceding the study.
  3. Females who are pregnant or breast-feeding
  4. Subjects must be non-smokers (patients who have never smoked or patients who have smoked ≤5 cigarettes per month and have a total pack-year smoking history < 10 packs).
  5. Use of marijuana >1 time per month in the last year and use of marijuana in the 6 weeks prior to enrollment
  6. Use of recreational drugs other than marijuana in the 12 months preceding the study.
  7. Use of Beta blocker medications
  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: NCT00917787

Locations
United States, California
UCSF Airway Clinical Research Center
San Francisco, California, United States, 94143-0130
Sponsors and Collaborators
University of California, San Francisco
Genentech
  More Information

No publications provided

Responsible Party: John V. Fahy, Professor in Residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00917787     History of Changes
Other Study ID Numbers: H6788-34128-01
Study First Received: June 8, 2009
Last Updated: September 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Asthma

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 29, 2014