Analysis of Blood-based Biomarkers of Asthma
ABBA
1 other identifier
observational
127
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedAugust 20, 2020
August 1, 2020
1.8 years
June 8, 2009
August 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
periostin levels in blood
1 week
Study Arms (2)
Healthy, Non-asthmatic
Asthma
Eligibility Criteria
Asthmatics and Non-asthmatics
You may qualify if:
- 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.
- Physician diagnosis of asthma
- PC20FEV1 methacholine ≤ 8.0 mg/mL, except for those taking daily inhaled corticosteroids, for which the PC20 methacholine should be \< 16 mg/mL.
- Ability to provide informed consent.
- 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.
- No lifetime history of asthma or allergic rhinitis.
- Ability to provide informed consent.
You may not qualify if:
- Lung disease other than asthma.
- History of an upper or lower respiratory tract infection in the 4 weeks preceding the study.
- Females who are pregnant or breast-feeding
- 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).
- Use of marijuana \>1 time per month in the last year and use of marijuana in the 6 weeks prior to enrollment
- Use of recreational drugs other than marijuana in the 12 months preceding the study.
- Use of Beta blocker medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- Genentech, Inc.collaborator
Study Sites (1)
UCSF Airway Clinical Research Center
San Francisco, California, 94143-0130, United States
Biospecimen
sputum, saliva, DNA, RNA, Plasma, serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 10, 2009
Study Start
June 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
August 20, 2020
Record last verified: 2020-08