DR32 DataRelease

SDY1086: Responses to Inactivated Influenza Vaccine (IIV) in adults with or without antibiotics
Status: New
Description: Single center, open mechanistic study in which subjects will be randomized to receive IIV per label at day 4 of a 5 day course of a specific antibiotic regimen (Group A) or IIV alone (Group B). Blood samples for immunologic testing will be collected at screening (from D -21 to D -1), on D0 (at vaccination), D1, D3, D7 (+/- 1 day), D30 (+/- 5 days), D90 (+/-14 days), D180 (+-/14 days), D365 (+/-28 days) post vaccination for both groups to study innate and/or adaptive immune responses. Stool samples will be collected in both groups at screening (from D - 21 to D -1), on vaccination (D0), D1, D3, D7 (+/- 1 day) and D30 (+/- 5 days), D90 (+/-14 days), D180 (+/-14 days), D365 (+/- 28 days) to study the gut microbiome in both groups. For Group A, additional visit on D-6 to D-3 will occur with stool and blood samples collection. Study will be conducted outside the 2014-2015 and 2015-2016 influenza seasons.Antibiotics received by Group A will be started 3 days prior to vaccination (D-3) and continued on day of vaccination (D0) and for one day after vaccination (D1) for a total of 5 days a) Flagyl 500 mg po tid b) Vancocin 125 mg po qid c) Neomycin sulfate 500mg po tid. The dosage of each antibiotic is taken from their respective package inserts and does not exceed the maximum dose allowed for each antibiotic. The antibiotic regimen is a broad spectrum regimen covering all types of fecal flora (anaerobes, gram positive, and gram negative bacteria); has a good safety record; has poor systemic absorption for part of the regimen (Vancocin and Neomycin sulfate ); and part of the regimen is used to treat Clostridium difficile infections (Vancocin and Flagyl). Subjects in Group A are asked to avoid all ethanol and any ethanol- containing drugs while taking antibiotics and for 48h before and after taking the antibiotics.
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-15-041 Systems Biological Analysis of Innate and Adaptive Responses to Vaccination (Emory)
DOI: 10.21430/M3GEIUPY7R
Subjects: 34
Study PI, contact:
NameOrganizationSite
Nadine Rouphael Emory University Hope Clinic
Publications:
Antibiotics-Driven Gut Microbiome Perturbation Alters Immunity to Vaccines in Humans.. Cell. Sep 2019. doi: 10.1016/j.cell.2019.08.010. [Pubmed: 31491384]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Cell Culture 416
DNA microarray 160
ELISA 392
ELISPOT 64
Flow Cytometry 444
Mass Spectrometry 211
Neutralizing Antibody Titer Assay 489
RNA sequencing 297
Sequencing 18
Surface Plasmon Resonance 198
Clinical Assessments:None
SDY1464: T cell responses to H1N1v and a longitudinal study of seasonal influenza vaccination SLVP015 2014
Status: New
Description: Systems biology approach to examine effects of seasonal flu vaccination in adults of different ages on gene expression, cytokine stimulation and serum cytokines with parameters such as immune senescence to uncover new markers and mechanisms behind failure of immune function in many older people.
Program/Contract:
ProgramContract
DOI: 10.21430/M3AUKDIXFI
Subjects: 26
Study PI, contact:
NameOrganizationSite
Mark Davis Stanford University Stanford University
Publications:
A clinically meaningful metric of immune age derived from high-dimensional longitudinal monitoring.. Nat Med. Mar 2019. doi: 10.1038/s41591-019-0381-y. Epub 2019 Mar 6. [Pubmed: 30842675]
Resources:
CliicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01827462]
Assays:None
Clinical Assessments:None
SDY1467: B-cell Immunity to Influenza SLVP017 2009
Status: New
Description: Systems biology approach to examine effects of seasonal flu vaccination in adults of different ages on gene expression, cytokine stimulation and serum cytokines with parameters such as immune senescence to uncover new markers and mechanisms behind failure of immune function in many older people.
Program/Contract:
ProgramContract
DOI: 10.21430/M3BNBGK39S
Subjects: 51
Study PI, contact:
NameOrganizationSite
Mark Davis Stanford University Stanford University
Publications:None
Resources:
CliicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT02133781]
Assays:
Assay TypeNumber of Exp. Samples
Hemagglutination Inhibition 294
Clinical Assessments:None
SDY1485: Subcutaneous Immunotherapy for Mouse in Adults (SCITMO/ICAC-26)
Status: New
Description: This study is an open label multi-site trial of mouse allergenic extract administered by subcutaneous injection in approximately 10 - 12 adults ages 18 to 55 years with asthma. The study will be based on a continuous treatment schedule with mouse allergenic extract for a period of approximately 24 weeks. It is primarily designed to study the safety of this therapy. There will be a Screening Visit followed by a Dose Initiation Visit, at which the subject will receive their first injection. Up to 2 doses of SCIT will be given weekly during dose escalation, separated by a minimum of 2 days. Dose escalation will occur over a minimum of 11 weeks. Dose escalation can be delayed at any point if there are excessive large local reactions or other concerns, although to continue on to maintenance each subject will need to reach the maintenance dose in a maximum of 18 weeks. Once the maintenance dose is achieved, bi-weekly visits will continue to complete a total of 24 weeks of treatment. Blood will be collected at baseline and then monthly for assessment of biomarkers of allergen immunotherapy, including mouse specific IgE, IgG, IgG4, and inhibition of mouse antigen binding to B-cells. Mouse skin testing will be performed at screening.
Program/Contract:
ProgramContract
Inner City Asthma Consortium (ICAC) RFA-AI-13-036 Inner City Asthma Consortium (ICAC)
DOI: 10.21430/M3XNRU4K3V
Subjects: 50
Study PI, contact:
NameOrganizationSite
Robert Wood Johns Hopkins University School of Medicine Johns Hopkins University School of Medicine
Publications:
Development of cockroach immunotherapy by the Inner-City Asthma Consortium.. J Allergy Clin Immunol. Mar 2014. doi: 10.1016/j.jaci.2013.08.047. Epub 2013 Nov 1. [Pubmed: 24184147]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT02532179]
Assays:None
Clinical Assessments:None
SDY1486: Development of a Comprehensive Antibody Staining Database using a Standardized Analytics Pipeline
Status: New
Description: The goal of this study was to apply a standardized CyTOF workflow and analysis pipeline in conjunction with the Biolegend Legendscreen kit to comprehensively screen surface protein expression patterns across all major defined immune cell subsets in peripheral blood and to evaluate the impact of fixation on these expression patterns
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-15-041 Dengue Human Immunology Project Consortium (DHIPC MSSM)
DOI: 10.21430/M3THZOC0FS
Subjects: 3
Study PI, contact:
NameOrganizationSite
Adeeb Rahman Icahn School of Medicine at Mt. Sinai Icahn School of Medicine at Mt. Sinai
Publications:
Development of a Comprehensive Antibody Staining Database Using a Standardized Analytics Pipeline.. Front Immunol. Jun 2019. doi: 10.3389/fimmu.2019.01315. eCollection 2019. [Pubmed: 31244854]
Resources:
Antibody Staining Data Set https://www.astrolabediagnostics.com/antibody_staining_data_set]
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 2194
Clinical Assessments:None
SDY1521: Memory B Cells with cross-reactive Abs to fluA(H1-H3)
Status: New
Description: To understand how the humoral immune system generates and matures protective responses to influenza virus infections and vaccinations. The group isolated B membory single cell clones from three unrelated, adult donors post TIV-vaccination, characterized the cross-reacting Abs to fluA (H1-H3) antigens, and generated the VDJ lineage tree of Bmem clones from one donor. The lineage and crystal structure analysis showed that members of a lineage had a BCR structure similar to that of a previously described Ab, encoded by different gene segments. Comparison showed that both Abs contacted the HA receptor-binding site through long heavy-chain third complementarity determining regions (HCDR3). Affinities of the clonal-lineage BCRs for historical influenza-virus HAs from both group 1 (H1) and group 2 (H3) viruses suggested that serial responses to seasonal influenza exposures had elicited the lineage and driven affinity maturation.
Program/Contract:
ProgramContract
Modeling Immunity for Biodefense RFA-AI-14-028 Modeling Affinity Maturation At Molecular Resolution
DOI: 10.21430/M3VTDIBF4T
Subjects: 0
Study PI, contact:
NameOrganizationSite
Stephen Harrison Harvard Medical School Howard Hughes Medical Institute
Publications:
Memory B Cells that Cross-React with Group 1 and Group 2 Influenza A Viruses Are Abundant in Adult Human Repertoires.. Immunity. Jan 2018. doi: 10.1016/j.immuni.2017.12.009. [Pubmed: 29343437]
Resources:
24 sequences submitted to Gene Bank https://www.ncbi.nlm.nih.gov/nuccore/?term=KY778717:KY778740[pacc]]
crystal structures data (K03.12 Fab ? 2012H3 ) http://www.rcsb.org/structure/5W08]
crystal structures data (UCA ? H1 SI-06) http://www.rcsb.org/structure/5W0D]
Assays:None
Clinical Assessments:None
SDY1522: Longitudinal study to common vaccines
Status: New
Description: Goal: To understand the longevity of humoral immune protection and the role played by memory B cells after common vaccinations. To quantify the heterogeneity in antibody responses to different vaccines and viruses. To quantify the time to loss of protective immunity to each vaccine or virus at the population level. Methods: Performed longitudinal data analysis on antibody titers for viral antigens (vaccinia, measles, mumps, rubella, varicella-zoster virus, and Epstein-Barr virus) and nonreplicating antigens (tetanus and diphtheria) in 45 subjects for a period of up to 26 years. Used a mixed-effects modeling framework to characterize the heterogeneity in antibody responses and to determine how variation in the magnitude and decay rate affect how protective immunity is lost at the population level to different virus and vaccine antigens. Results: Antiviral antibody responses were remarkably stable, with half-lives ranging from an estimated 50 years for varicella-zoster virus to more than 200 years for other viruses such as measles and mumps. Antibody responses against tetanus and diphtheria antigens waned more quickly, with estimated half-lives of 11 years and 19 years, respectively. B-cell memory was long-lived, but there was no significant correlation between peripheral memory B-cell numbers and antibody levels for five of the eight antigens tested. The statistical analysis and models helped to stratify the heterogenity factors and quantified each in a single plot to view interplays of factors, such as the fast-decay of anti-nonreplicating-antigens is compensated for by the higher magnitude of responses (relative to the level for protection) which explains a higher fraction of vaccinated individuals have protective immunity to tetanus and diphtheria than to measles, rubella, and vaccinia in the first 4 decades, suggesting the need for reevaluation of their boosting schedules.
Program/Contract:
ProgramContract
Modeling Immunity for Biodefense RFA-AI-14-028 Dynamics And Evolution Of Immune Responses To Influenza Viruses
DOI: 10.21430/M3F210A2MA
Subjects: 0
Study PI, contact:
NameOrganizationSite
Mark Slifka Oregon Health & Science University Vaccine and Gene Therapy Institute
Rustom Antia Emory University Department of Biology
Publications:
Duration of humoral immunity to common viral and vaccine antigens.. N Engl J Med. Nov 2007. doi: - [Pubmed: 17989383]
-. - - -. doi: - [Pubmed: 30096134]
Resources:
17989383_supplement https://www.nejm.org/doi/suppl/10.1056/NEJMoa066092/suppl_file/nejm_amanna_1903sa1.pdf]
Assays:None
Clinical Assessments:None
SDY1528: Preeclampsia Study
Status: New
Description: Preeclampsia is one of the most severe pregnancy complications and a leading cause of maternal death. However, early diagnosis of preeclampsia remains a clinical challenge, only limited information of select immune cell subsets is available. The goal is to detect characteristic immune dysfunctions in the maternal blood prior to the clinical onset of preeclampsia. The study used a high-dimensional mass cytometry immunoassay to characterize the dynamic changes of over 370 immune cell features in maternal blood during healthy and preeclamptic pregnancies. Results: A set of eight cell-specific immune features that accurately predict the preeclampsia well before the clinical diagnosis is identified. Several features recapitulated previously known immune dysfunctions in preeclampsia, such as elevated pro-inflammatory innate immune responses early in pregnancy and impaired regulatory T (Treg) cell signaling. The analysis revealed additional novel immune responses that were strongly associated with, and preceded the onset of preeclampsia, notably abnormal STAT5ab signaling dynamics in CD4+T cell subsets (AUC 0.92, p = 8.0E-5). These results provide a global readout of the dynamics of the maternal immune system early in pregnancy and lay the groundwork for identifying clinically-relevant immune dysfunctions for the prediction and prevention of preeclampsia
Program/Contract:
ProgramContract
March of Dimes March of Dimes Human Microbiome
DOI: 10.21430/M32422NUZU
Subjects: 23
Study PI, contact:
NameOrganizationSite
Brice Gaudilliere Stanford University Department of Anesthesiology, Perioperative and Pain Medicine
Publications:
Differential Dynamics of the Maternal Immune System in Healthy Pregnancy and Preeclampsia.. Front Immunol. Jun 2019. doi: 10.3389/fimmu.2019.01305. eCollection 2019. [Pubmed: 31263463]
Resources:
31263463_demographic https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6584811/table/T1/]
31263463_CyTOF_fcs http://flowrepository.org/id/FR-FCM-ZYRQ]
Assays:None
Clinical Assessments:None
SDY1529: Transcriptional profiling of yellow fever vaccine-naive participants bafore and after vaccination against yellow fever.
Status: New
Description: Post-vaccination transcriptomic profiling at days 3, 7, 14 and 84 and other immune parameters have been investigated in association with the immune response, at day 80 post-vaccination, to Yellow Fever vaccine (YF-17D) in a cohort of 36 participants recruited in Entebee (Uganda).
Program/Contract:
ProgramContract
Bill and Melinda Gates Foundation Immune activation alters cellular and humoral responses to yellow fever 17D vaccine
DOI: 10.21430/M36X4BH892
Subjects: 36
Study PI, contact:
NameOrganizationSite
Rafick-Pierre Sekaly Case Western Reserve University Case Western Reserve University
Publications:None
Resources:
Gene Expression Omnibus GSE125921]
Gene Expression Omnibus GSE136163]
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 180
Neutralizing Antibody Titer Assay 72
Clinical Assessments:None
SDY67: Bioinformatics Approach to 2010-2011 TIV Influenza A/H1N1 Vaccine Immune Profiling
Status: Updated
Description: Aim 1: Characterize Immune Profiles Over Time, Aim 2: Correlate Immune Profiles with Vaccine Immunogenicity,Aim 3: Replication of Immune Profiles and Verification of Models
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-14-007 Bioinformatics Approach to Influenza A/H1N1 Vaccine Immune Profiling
DOI: 10.21430/M3OYWCJHO1
Subjects: 159
Study PI, contact:
NameOrganizationSite
Gregory Poland Mayo Clinic Mayo Clinic
Publications:
The impact of immunosenescence on humoral immune response variation after influenza A/H1N1 vaccination in older subjects.. PLoS One. Mar 2015. doi: 10.1371/journal.pone.0122282. eCollection 2015. [Pubmed: 25816015]
System-Wide Associations between DNA-Methylation, Gene Expression, and Humoral Immune Response to Influenza Vaccination.. PLoS One. Mar 2016. doi: 10.1371/journal.pone.0152034. eCollection 2016. [Pubmed: 27031986]
Gene signatures related to HAI response following influenza A/H1N1 vaccine in older individuals.. Heliyon. May 2016. doi: 10.1016/j.heliyon.2016.e00098. eCollection 2016. [Pubmed: 27441275]
Simultaneous enumeration of cancer and immune cell types from bulk tumor gene expression data.. Elife. Nov 2017. doi: 10.7554/eLife.26476. [Pubmed: 29130882]
Resources:
NIH Reporter 5U01AI089859-05 http://projectreporter.nih.gov/project_info_details.cfm?aid=8695082]
Assays:
Assay TypeNumber of Exp. Samples
Cell Culture 556
DNA methylation profiling assay 952
ELISPOT 1113
Flow Cytometry 3387
Hemagglutination Inhibition 1272
Mass Spectrometry 61
Meso Scale Discovery ECL 1272
PCR 466
Q-PCR 159
RNA sequencing 1100
Virus Neutralization 635
Clinical Assessments:None
SDY887: Defective signaling in aging, influenza vaccination 2007 SLVP015
Status: Updated
Description: Pilot year. Despite the importance of the immune system in many diseases, there are currently no objective benchmarks of immunological health. In an effort to indentify benchmarks of immunological health, influenza vaccination was used in 10 young (20-30 years) and 19 older subjects (60 to 89 years) as models for strong and weak immune responses, respectively. Serological responses to influenza strains as well as a wide variety of other parameters, including gene expression, antibodies to hemagglutinin peptides, serum cytokines, cell subset phenotypes and in vitro cytokine stimulation were measured. Using machine learning, nine variables predicting antibody response with 84% accuracy were identified. Two of these variables are involved in apoptosis, which positively associated with the response to vaccination and was confirmed to be a contributor to vaccine responsiveness in mice. The identification of these biomarkers provides new insights into what immune features may be most important for immune health.
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-14-007 Vaccination and infection: indicators of immunological health and responsiveness
DOI: 10.21430/M33JMYFLF1
Subjects: 29
Study PI, contact:
NameOrganizationSite
Cornelia Dekker Stanford University Stanford University
Publications:
Defective Signaling in the JAK-STAT Pathway Tracks with Chronic Inflammation and Cardiovascular Risk in Aging Humans.. Cell Syst. Oct 2016. doi: 10.1016/j.cels.2016.09.009. Epub 2016 Oct 13. [Pubmed: 27746093]
Resources:
Department of Pediatrics- Infectious Diseases Stanford University School of Medicine http://med.stanford.edu/pedsid/contact.html]
Shen-Orr Lab, Technion http://shenorrlab.technion.ac.il/]
clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT01827462]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 382
Neutralizing Antibody Titer Assay 174
Clinical Assessments:None
SDY888: Human Immune Signature of Dengue virus infection- Gene Expression of CD4 subsets
Status: Updated
Description: The human Immune Signature of Dengue virus infection was studied in two endemic areas. T cell responses were compared in infected patients and uninfected individuals also from Dengue endemic areas.
Program/Contract:
ProgramContract
Human Immunology Project Consortium (HIPC) RFA-AI-15-041 Human immune signatures of dengue virus and mycobacterium tuberculosis exposure in infection; disease and vaccination (La Jolla)
DOI: 10.21430/M3C4L4WD2Z
Subjects: 102
Study PI, contact:
NameOrganizationSite
Alessandro Sette La Jolla Institute for Allergy and Immunology La Jolla Institute for Allergy and Immunology
Publications:
Unique phenotypes and clonal expansions of human CD4 effector memory T cells re-expressing CD45RA.. Nat Commun. Nov 2017. doi: 10.1038/s41467-017-01728-5. [Pubmed: 29133794]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 24
HLA Typing 13
RNA sequencing 74
Clinical Assessments:None
SDY1025: Asthma Phenotypes in the Inner City (APIC/ICAC-19)
Status: Updated
Description: This study looks to define the phenotypic characteristics of Difficult-to-Treat asthma, among 650 children between the ages of 6 to 17 years, receiving one year of guidelines-based therapy for asthma and rhinitis/rhinosinusitis.
Program/Contract:
ProgramContract
Inner City Asthma Consortium (ICAC) RFA-AI-13-036 Inner City Asthma Consortium (ICAC)
DOI: 10.21430/M39SEUM79K
Subjects: 717
Study PI, contact:
NameOrganizationSite
William Busse University of Wisconsin-Madison University of Wisconsin-Madison
Publications:
Asthma phenotypes in inner-city children.. J Allergy Clin Immunol. Oct 2016. doi: 10.1016/j.jaci.2016.06.061 [Pubmed: 27720016]
Distinguishing characteristics of difficult-to-control asthma in inner-city children and adolescents.. J Allergy Clin Immunol. Oct 2016. doi: 10.1016/j.jaci.2016.06.059 [Pubmed: 27720017]
Pathways through which asthma risk factors contribute to asthma severity in inner-city children.. J Allergy Clin Immunol. Oct 2016. doi: 10.1016/j.jaci.2016.06.060 [Pubmed: 27720018]
Obstruction phenotype as a predictor of asthma severity and instability in children.. J Allergy Clin Immunol. Nov 2017. doi: 10.1016/j.jaci.2017.09.047 [Pubmed: 29146272]
Expression of Corticosteroid Regulated Genes By Peripheral Blood Mononuclear Cells in Children with Asthma.. J Allergy Clin Immunol. Jul 2018. doi: 10.1016/j.jaci.2018.06.043 [Pubmed: 30059697]
Rhinitis in Children and Adolescents with Asthma: Ubiquitous, Difficult to Control, and Associated with Asthma Outcomes.. J Allergy Clin Immunol. Sep 2018. doi: 10.1016/j.jaci.2018.07.041 [Pubmed: 30213627]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/study/NCT01383941]
Assays:None
Clinical Assessments:
Allergen Skin Test
Body Mass Index
Composite Asthma Severity Index
Exhaled Nitric Oxide
Indoor Allergens
Ipratropium Reversibility
Methacholine Challenge
Perceived Stress Scale
Plesthymography
Rhinitis/Rhinosinusitis Diagnostic Questionnaire
Spirometry
SDY1026: Biomarkers of Cockroach Sublingual Immunotherapy 2 (BioCSI 2/ICAC-17)
Status: Updated
Description: This study looks to compare two doses of glycerinated German cockroach allergenic extract versus placebo administered via the sublingual route in 99 children ages 5 to 17 years with perennial allergic rhinitis, asthma, or both. It is designed to study biomarkers of the immune response to allergen immunotherapy as well as the safety of this therapy.
Program/Contract:
ProgramContract
Inner City Asthma Consortium (ICAC) RFA-AI-13-036 Inner City Asthma Consortium (ICAC)
DOI: 10.21430/M3LVUFRQOA
Subjects: 99
Study PI, contact:
NameOrganizationSite
Robert Wood Johns Hopkins University School of Medicine Johns Hopkins University School of Medicine
Publications:
Development of cockroach immunotherapy by the Inner-City Asthma Consortium.. J Allergy Clin Immunol. Mar 2014. doi: 10.1016/j.jaci.2013.08.047 [Pubmed: 24184147]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/study/NCT01380327]
Assays:None
Clinical Assessments:None
SDY1027: The Role of Epigenetics in Inner City Asthma (ICAC-15)
Status: Updated
Description: The study is designed to determine the relation between methylation of CpG motifs and asthma in children residing in the inner city.
Program/Contract:
ProgramContract
Inner City Asthma Consortium (ICAC) RFA-AI-13-036 Inner City Asthma Consortium (ICAC)
DOI: 10.21430/M3SXDBHQTS
Subjects: 200
Study PI, contact:
NameOrganizationSite
David Schwartz National Jewish Health National Jewish Health
Andrew Liu National Jewish Health National Jewish Health
Herman Mitchell Rho, Inc. Rho, Inc.
Publications:
DNA methylation and childhood asthma in the inner city.. J Allergy Clin Immunol. Jul 2015. doi: 10.1016/j.jaci.2015.01.025 [Pubmed: 25769910]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/study/NCT01382836]
Assays:
Assay TypeNumber of Exp. Samples
DNA methylation profiling assay 194
Transcription profiling by array 194
Clinical Assessments:None
SDY1028: Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (PROSE/ICAC-20)
Status: Updated
Description: A three-armed prospective randomized double-blind placebo-controlled trial investigating the efficacy of standard care plus 4-5 months of treatment with (a) a boost of inhaled corticosteroid therapy Flovent Diskus (fluticasone) versus (b) Xolair(omalizumab) or (c) placebo Xolair (omalizumab) and placebo Flovent Diskus (fluticasone) in reducing the exacerbations during the fall season.
Program/Contract:
ProgramContract
Inner City Asthma Consortium (ICAC) RFA-AI-13-036 Inner City Asthma Consortium (ICAC)
DOI: 10.21430/M3HZZOS3Y5
Subjects: 513
Study PI, contact:
NameOrganizationSite
William Busse University of Wisconsin-Madison University of Wisconsin-Madison
Samuel Arbes Rho Rho
Publications:
Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations.. J Allergy Clin Immunol. Dec 2015. doi: 10.1016/j.jaci.2015.09.008 [Pubmed: 26518090]
A computerized decision support tool to implement asthma guidelines for children and adolescents.. J Allergy Clin Immunol. May 2019. doi: 10.1016/j.jaci.2018.10.060 [Pubmed: 30529451]
Distinct nasal airway bacterial microbiotas differentially relate to exacerbation in pediatric patients with asthma.. J Allergy Clin Immunol. Jun 2019. doi: - [Pubmed: 31201890]
Resources:
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/study/NCT01430403]
Assays:None
Clinical Assessments:
Asthma Control Test
Childhood Asthma Control Test
Dust Sample Lab Results
Exhaled Nitric Oxide
Spirometry
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