Characterization of Adult Subjects for Asthmatic Research Studies (CASA)

University of California San Francisco (UCSF)

Status: Suspended

Conditions: Asthma

Study type: Observational

Funder types: Other

Identifiers

NCT01508078

10-01627

Details and patient eligibility

About

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.

Full 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.

Enrollment: 259 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

259 participants in 2 patient groups

Asthmatics

Description:

Otherwise healthy asthmatic subjects

Healthy controls

Description:

Healthy individuals without evidence of pulmonary disease.