Characterization of Adult Subjects for Asthmatic Research Studies (CASA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
John V. Fahy, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01508078
First received: January 6, 2012
Last updated: March 4, 2015
Last verified: March 2015
  Purpose

This study is designed to characterize subjects in terms of the nature and severity of their asthma and in terms of conditions that may alter the clinical expression of asthma. Some features will be obtained in all subjects. These include a medical history and baseline lung function tests. This characterization forms the basis for our database that facilitates research protocols.


Condition
Asthma

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Characterization of Adult Subjects for Asthmatic Research Studies

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

Primary Outcome Measures:
  • Airway inflammation [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]
    We will measure various indicators of airway inflammation and compare them with various phenotypic characteristics.


Biospecimen Retention:   Samples With DNA

Samples of induced sputum and blood for DNA and RNA extraction, plasma, and serum will be banked in the UCSF Airway Tissue Bank.


Estimated Enrollment: 2000
Study Start Date: May 2010
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asthmatics
Otherwise healthy asthmatic subjects
Healthy controls
Healthy individuals without evidence of pulmonary disease.

Detailed Description:

The purpose of this study is to generate a cohort of well-characterized asthmatic subjects as a resource for recruitment of asthmatic subjects and healthy controls in clinical studies and clinical trials in the UCSF Airway Clinical Research Center. The UCSF Airway Clinical Research Center (ACRC) conducts multiple clinical research studies in asthma funded by the NIH, foundations, and industry. We have a broad range of research interests, but we have specific interests in mechanism-oriented clinical studies and specific expertise in biospecimen collection, biobanking, and biospecimen analysis. Our model is to have multiple studies recruiting simultaneously, and this means that we need well-organized recruitment and database systems.

Additionally, we aim to characterize asthmatic subjects in multiple domains, including disease severity, airway inflammation subtypes, and mucus subtypes. Asthma is a heterogeneous disease in its clinical presentation and in its underlying cellular and molecular phenotypes. To explore cellular and molecular phenotypes of asthma, we will analyze induced sputum for cell types and gene expression, with a focus on Th2 inflammation pathways and innate and adaptive immune cells that drive Th2 inflammation. Detailed cellular analysis of sputum is possible but requires that multiple sputum samples be collected for processing in multiple different ways, including by cytocentrifugation, FACS analysis, and by formalin fixation and paraffin embedding of sputum cell pellets. We are also studying mucus phenotypes of asthma using methods of rheology, which needs to be done on fresh sputum.

  Eligibility

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

Asthmatics and healthy control

Criteria

Inclusion Criteria:

  • Age 18 years and older

Exclusion Criteria:

  • History of lung disease other than asthma
  • An upper respiratory tract infection or an exacerbation of their asthma within the preceding 4-6 weeks.
  • Persons who have smoked > 5 cigarettes per month and have a total pack-year smoking history > 10 packs.
  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: NCT01508078

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Ida Cao    415-476-5043      
Principal Investigator: John V Fahy, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: John Fahy, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: John V. Fahy, Professor in Residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01508078     History of Changes
Other Study ID Numbers: 10-01627
Study First Received: January 6, 2012
Last Updated: March 4, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 30, 2015