Characterization of Adult Subjects for Asthmatic Research Studies (CASA)

September 3, 2025 updated by: University of California, San Francisco
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.

Study Overview

Status

Suspended

Conditions

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.

Study Type

Observational

Enrollment (Actual)

259

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Asthmatics and healthy control

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Asthmatics
Otherwise healthy asthmatic subjects
Healthy controls
Healthy individuals without evidence of pulmonary disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Airway inflammation
Time Frame: Cross-sectional
We will measure various indicators of airway inflammation and compare them with various phenotypic characteristics.
Cross-sectional

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: John Fahy, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2010

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 6, 2012

First Submitted That Met QC Criteria

January 10, 2012

First Posted (Estimated)

January 11, 2012

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-01627

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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