Clinical trial NCT01508078: Characterization of Adult Subjects for Asthmatic Research Studies
Official title: Characterization of Adult Subjects for Asthmatic Research Studies
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Asthma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asthmatics and healthy control

Brief 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.

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 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.

Primary outcomes:
measure: Airway inflammation
timeFrame: Cross-sectional
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: John Fahy, MD
role: PRINCIPAL_INVESTIGATOR
References: