Characterization of Adult Subjects for Asthmatic Research Studies

Asthma Clinical Trial

— CASA  

Official title:

Characterization of Adult Subjects for Asthmatic Research Studies

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01508078
• Other study ID #: 10-01627
• Status: Suspended
• Start date: May 2010
• Est. completion date: July 2025

Study information

• Verified date: February 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 259
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway inflammation	We will measure various indicators of airway inflammation and compare them with various phenotypic characteristics.	Cross-sectional

External Links

•   Airway Clinical Research Center website