NCT00917787

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

1.8 years

First QC Date

June 8, 2009

Last Update Submit

August 18, 2020

Conditions

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

  • periostin levels in blood

    1 week

Study Arms (2)

Healthy, Non-asthmatic

Asthma

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

UCSF Airway Clinical Research Center

San Francisco, California, 94143-0130, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

sputum, saliva, DNA, RNA, Plasma, serum

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

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

Locations