Implications and Stability of Clinical and Molecular Phenotypes of Severe Asthma (SARPIII)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Implications and Stability of Clinical and Molecular Phenotypes of Severe Asthma|
- Airway lumen mast cells [ Time Frame: Once, during bronchoscopy ] [ Designated as safety issue: No ]Determine the impact of mast cell markers on human airway epithelial cell phenotype and function.
- Longitudinal asthma phenotype [ Time Frame: Change rates, determined annually for three years ] [ Designated as safety issue: No ]
Determine the long term stability and implications of previously identified clinical and molecular asthma phenotypes, specifically the mast cell signature, and identify potential systemic biomarkers for these phenotypes.
Determine whether a biomarker for the lung mast cell signature can be identified in serum/plasma of both adult and pediatric severe asthmatics
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2019|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Longitudinal follow up
Patients will undergo a characterization phase, which includes a baseline evaluation (1 visit), and a steroid responsiveness evaluation (2 visits). The longitudinal phase will include 3 office visits (annually) over 36 months with bi-annual phone calls. During the study patients will answer questionnaires, perform lung function testing and provide blood, urine, sputum and exhaled breath condensate samples.
Drug: Triamcinolone Acetonide
Each subject that meets inclusion/exclusion criteria will receive triamcinolone acetonide intramuscularly at the end of visit 2. Adults ≥18 years will receive 40 mg triamcinolone acetonide. Children 6-17 years will receive 1 mg/kg triamcinolone acetonide (up to 40 mg maximum). Triamcinolone acetonide will be administered as a single intramuscular dose deep in the gluteal region
Other Name: Kenalog
The longitudinal follow-up study is divided into a characterization and longitudinal phase. During the characterization subjects will undergo a baseline evaluation that will include will include answering questionnaires, lung function testing, and chest tomography. Subsequently, to determine steroid responsiveness, all subjects will receive one intramuscular dose of 40 mg in 1ml (1 mg/kg for children <18 years old, up to 40 mg maximum. Participants at the University of Pittsburgh will undergo a bronchoscopy to provide airway samples. The longitudinal phase will include a 36 month follow-up time with annual visits and phone calls every 6 months. During it, participants will answer questionnaires and provide sputum samples on two occasions, and will perform lung function testing.
The SARP III longitudinal follow up study (all centers) will determine the long term stability and implications of clinical and molecular asthma phenotypes and identify potential systemic biomarkers for these phenotypes
The University of Pittsburgh center will test the hypothesis that a) a mast cell signature is present and longitudinally maintained in severe asthma; and b) That the persistent signature determines short and long term outcomes through interactions with lung and inflammatory cells.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748175
|United States, Pennsylvania|
|Asthma Institute, UNiversity of Pittsburgh and University of Pittsburgh School of Medicine|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Sally E Wenzel, MD||University of Pittsburgh|
|Study Director:||Fernando Holguin, MD MPH||University of Pittsburgh|