Implications and Stability of Clinical and Molecular Phenotypes of Severe Asthma (SARP III)
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Purpose
The Severe Asthma Research Program III is an NIH cooperative agreement involving 7 clinical centers that encompass a multidisciplinary partnerships between asthma clinician-scientists and scientists with expertise in immunology, pulmonary physiology, molecular genetics, molecular phenotyping, imaging, and bioinformatics. These clinical centers will jointly recruit volunteers with asthma for an observational longitudinal follow-up study. However, centers will also conduct specific mechanistic research projects at each participating institution. The University of Pittsburgh's SARP III study will determine the molecular and clinical stability of asthma phenotypes over time.
| Condition | Intervention |
|---|---|
|
Asthma Severe Persistent Asthma |
Drug: Triamcinolone Acetonide |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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
| Estimated Enrollment: | 700 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Previous asthma diagnosis
- FEV1 bronchodilator reversibility ≥12% or airway hyperresponsiveness reflected by a methacholine PC20 ≤16 mg/mL (Historical methacholine data from previous NIH trial [SARP I or II, AsthmaNet, ALA-ACRC, ACRN or CARE] will be allowed).
Exclusion Criteria:
- Exclusion criteria include any of the following:
- Pregnancy during the characterization phase
- Current smoking,
- Smoking history > 10 pack years if ≥30 years of age, or smoking history > 5 pack years if <30 years of age (Note: if a subject has a smoking history, no smoking within the past year),
- Other chronic pulmonary disorders associated with asthma-like symptoms, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction (that is the sole cause of respiratory symptoms and at the PI's discretion), severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways,
- History of premature birth before 35 weeks gestation,
- Unwillingness to receive an intramuscular triamcinolone acetonide injection.
- Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures,
- Planning to relocate from the clinical center area before study completion,
- Any other criteria that place the subject at unnecessary risk according to the judgment of the Principal Investigator and/or attending physician(s) of record, or
- Currently participating in an investigational drug trial.
Contacts and Locations| Contact: Amanda Pietras | 412-864-2219 | pietrasam@upmc.edu |
| United States, Pennsylvania | |
| Asthma Institute, UNiversity of Pittsburgh and University of Pittsburgh School of Medicine | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: Sally E Wenzel, MD | |
| Sub-Investigator: Fernando Holguin, MD MPH | |
| Principal Investigator: | Sally E Wenzel, MD | University of Pittsburgh |
| Study Director: | Fernando Holguin, MD MPH | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01748175 History of Changes |
| Other Study ID Numbers: | 1010HL109152-01 |
| Study First Received: | November 27, 2012 |
| Last Updated: | January 3, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Severe asthma longitudinal study phenotypes |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide |
Triamcinolone diacetate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013