Frederick M. Schaffer, M.D.
CURRICULUM VITAE
EDUCATION
B.S. Physics
City College of New York
1968-1972
M.S. Nutr. Biochemistry
Columbia University College of Physicians and Surgeons
1976-1977
M.D.
SUNY Downstate Medical College
1977-1981
Residency
Einstein U. Hospitals
Dept. of Pediatrics
Bronx, New York
1981-1984
Chief Resident
Out-Patient Division
Dept. of Pediatrics
Einstein U. Hospitals
1984
First Fellowship
The Hospital for Sick Children
Division of Allergy, Immunology, and Rheumatology
The University of Toronto
1984-1986
Second Fellowship
The University of Alabama at Birmingham
Division of Developmental and Clinical Immunology
Birmingham, Alabama
1986-1988
MEDICAL LICENSURE
Alabama
Mississippi
New York
South Carolina
#13104, 10/86
#14214, 12/94
#157676-1, 1/83
#23028
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EMPLOYMENT HISTORY
1988-1991
Senior Research Associate
The University of Alabama
at Birmingham, Division of
Developmental and Clinical
Immunology, Birmingham, AL
1991-1995
Assistant Professor
Allergy/Immunology/Pediatric
Rheumatology and Pediatrics
The Children’s Hospital of Buffalo
The Division of Allergy/Clinical
Immunology and Rheumatology
SUNY at Buffalo, Buffalo, NY
1995-1997
Attending Allergist/Immunologist
Pediatrician
Baptist Memorial Golden Triangle
Hospital, Columbus, MS
1997-2002
Allergist/Immunologist
Allergy/Immunology practice
Mississippi
2002-present
Associate Professor
Pediatrics/ Allergy & Immunology
Dept. Pediatrics
Division of Pediatric Pulmonary, Allergy &
Immunology
Medical University of South Carolina,
Charleston
Editorial, Writing, and Pharmaceutical Related Positions
Editorial Board Member for peer reviewed journal
Open Autoimmunity, (2008 – present)
Editor for international science/medical arts company. (Edited papers in the fields of Immunology, Oncology,
Pediatrics, Rheumatology, Dermatology and Nursing)
MedCom, Taiwan, (2005-present)
Scientific writer for Pharmaceutical Co.
Book chapters pertaining to Internal Medicine, Hematology/Oncology, Asthma, Cardiology, and Rheumatology
(2003-present)
Consultant to International Pharmaceutical Companies- Marketing and Product Development
(1996-present)
CME course developer and instructor for International Pharmaceutical Companies.
(1996-present)
Clinical Trials: over 25 as primary or co-investigator
(2002-present)
PROFESSIONAL ASSOCIATIONS
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American Academy of Allergy, Asthma and Immunology – Fellow
American College of Allergy, Asthma and Immunology – Fellow
American Immunology Association – Fellow
Clinical Immunology Society
American Medical Writers Association
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BOARD CERTIFICATION/ELIGIBILITY
American Board of Pediatrics
American Board of Allergy/Immunology
Board Eligible in Pediatric Rheumatology
Date: 1994; Recertification: 2002
Date: 1999; Recertification: 2009
HONORS/AWARDS
Recipient of two N.Y.S. Regents Scholarships (1968-1972)
Member of two Honor Societies
Graduate School Scholarship from Columbia University (1976-1977)
Recipient of American Rheumatology Association Fellowship Research Award (1985)
Recipient of the University of Toronto Research Award “First Place” (1986)
NIH Clinical Associate Physician Research Grant (1988-1991)
Invited Symposium Speaker-Fed. of American Scientists & Experimental Biologists (1989)
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Invited Symposium Speaker 7 International Congress of Immunology-Berlin (1989)
Recipient of Children’s Hospital of Buffalo-Women’s and Children’s Foundation Research Grant (1991-1993)
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Invited 15 International Pediatric and Adult Allergy/Immunology Conference – Toronto (1992)Symposium
Speaker
Recipient of Arthritis Foundation Research Grant (1993-1994)
Recipient of American Heart Association Research Grant (1993-1995)
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Invited Symposium Speaker 16 International Pediatric and Adult Allergy/Immunology Conference – Toronto
(1993)
Invited Mini-Symposium Speaker National Rheumatology Conference San Antonio (1993)
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Invited Symposium Speaker 17 International Pediatric and Adult Allergy/Immunology Conference – Toronto
(1994)
Offered NIH Research Grant, Shannon Award (1995-1997)
Invited Faculty Member to the Bristol-Myers Infectious Disease Conference (1996)
Invited Conference Speaker-Dept. Biochemistry and Molecular Biology, Mississippi State University (1996)
Reviewer for International Scientific Journals (1993-to the present)
Regional and National Speaker for Pharmaceutical Concerns (1995-present)
Recipient of Clinical Research Grant from Sepracor, Inc (2004-2005)
PUBLICATIONS
1.
Roifman, CM, Schaffer, FM, Wachsmuth, SE, Murphy, G, and Gelfand EW: Reversal of chronic polymyositis
following intravenous immune serum globulin therapy. J. AM Med. Assoc. 258:513-515, 1987.
2.
Laxer, RM, Schaffer, FM, Myones, GL, Young, WJ, Rowe, RD, Rubin, L, Stein, LD, Gelfand, EW: Lymphocyte
abnormalities and complement activation in Kawasaki disease. Prog. Clin. Biol. Res. 250:175-184, 1987.
3.
Schaffer, FM, Benedict, SH, Petsche, D, Lau, A, Williams, BRB, Mills, GB, and Gelfand, EW: Interferon and
Phorbol esters down-regulate sIgM expression by independent pathways. J. Cell. Physiol. 134:245-252, 1988.
4.
Koren, F, Schaffer, FM, Silverman, E, Walker, S, Duffy, C, Stein, L, Suri, D, Schue, S, Thiessen, JJ, Gelfand, EW,
and Laxer, R: Determinants of low serum concentrations of salicylates in patients with Kawasaki disease. J.
Pediatr. 112:663-667.
5.
Schaffer, FM, Palermos, J, Zhu, ZB, Barger, BO, Cooper, MD, and Volanakis, JE: Individuals with IgA deficiency
and common variable immunodeficiency share polymorphisms of major histocompatibilty complex class III
genes. Proc. Natl. Acad. Sci. USA, 86:8015-8019, 1989.
6.
Schaffer, FM, Palermos, J, Zhu, ZB, Barger, BO, Cooper, MD, and Volanakis, JE: Genotypic studies of MHC class
III genes in individuals with IgA deficiency and common variable immunodeficiency. In: Progress in
Immunology, VII. Melchers, F, et al., eds. Springer-Verlag. Heidelberg, pp.544-546, 1989.
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7.
Volanakis, JE, Zhu, ZB, Schaffer, FM, Palermos, J, Barger, BO, Campbell, RD, Schroeder, HW, Jr., and Cooper,
MD: MHC class III gene(s) endow(s) susceptibility to both IgA deficiency and common variable
immunodeficiency. In: Progress in Immune Deficiency III, Chopel, HM, Levinsky, RJ, and Webster, HDB, eds.
Royal Society of Medical Services, Ltd., pp.27-30, 1991.
8.
Schaffer, FM, Monteiro, RC, Volanakis, JE, and Cooper, MD: IgA Deficiency. Immunodeficiency Rev. 15-44,
1991.
9.
Volanakis, JE, Zhu, ZB, Schaffer, FM, Macon, KJ, Palermos, J, Barger, BO, Go, R, Campbell, RD, Schroeder, HW,
Jr., and Cooper, MD: MHC class III genes and susceptibility to IgA deficiency and common variable
immunodeficiency. J. Clin. Invest. 89:1914-1922, 1992.
10. Ashman, RF, Schaffer, FM, Kemp, JD, Yokoyama, WM, Cooper, MD, and Volanakis, JE: Genetic and
immunologic analysis of a family containing 5 patients with common variable immunodeficiency or selective
IgA deficiency. J. Clin. Immunol. 12:406-414, 1992.
11. Ballow, M, and Schaffer, FM: Molecular genetics of immunoglobulin genes and the generation of antibody
diversity. In: Molecular and Cellular Immunology of the Allergic and Immune Response. Levsin, AL, and
Patterson, Y, eds. Marcel Dekker Inc. N.Y. pp.3-40, 1994.
12. Schaffer, FM, and Newton, JA: Intravenous gamma globulin administration to common variable
immunodeficient women during pregnancy. Case report and review of the literature. J. Perinatol. 14:114-117,
1994.
13. Schaffer, FM, Argawal, R, Helm, J, Gingell, RI, Roland, JMA, and O’Neil, KM: Post-streptococcal reactive
arthritis and silent carditis: A case report and review of the literature. Pediatrics 12:837-839, 1994.
14. Schaffer, FM, and Ballow, M: Immunodeficiency: Office work-up. J. Resp. Dis. 16:523-546, 1995.
15. Bernstein, JM, Shanahan, TC, and Schaffer, FM: Further observations on the role of the MHC genes and certain
hearing disorders. Acta Otolaryngol. 116:666-667, 1996.
16. Schaffer, FM: Immune Deficiency During Pregnancy. In: Asthma and Immunologic diseases in Pregnancy and
Early Infancy. Schatz, M, Zeiger, R, Claman, H. eds. Marcel Dekker Inc. N.Y. pp.605-638, 1998.
17. Goldblatt, M, Basco Jr. WT, and Schaffer FM: Another Failure to Thrive? (Atypical SCID Presentation)
Contemporary Pediatr. May, 2006.
18. Schaffer FM: Clinical assessment and management of abnormal IgA levels. Ann of Allergy and Immunol. 100:
280-282, 2008.
19. F. M. Schaffer, I. Virella-Lowell, R. A. Gatti, D. L. Gossage. Ataxia-Telangiectasia, Associated with a Rare
1339C>T ATM mutation, presenting in infancy with Pneumocystis carinii pneumonia, and an elevated serum
IgM. In preparation, 2009.
SYMPOSIUM SPEAKING ENGAGEMENTS
1.
Schaffer, FM, Palermos, J, Zhu, ZB, Barger, BO, Cooper, MD, and Volanakis, JE: Individuals with IgA deficiency
and common variable immunodeficiency share polymorphisms of major histocompatibility complex class III
genes. Fed. Proc., (May, 1989).
2.
Schaffer, FM, Palermos, J, Zhu, ZB, Barger, BO, Cooper, MD, and Volanakis, JE: Genotypic studies of MHC class
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III genes in individuals with IgA deficiency and common variable immunodeficiency. 7 International Congress
of Immunology, Berlin, (August, 1989).
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3.
Schaffer, FM: The Role of the MHC genes in Asthma and Allergic Disorders, 15 International Allergy and
Immunology Meeting, Toronto, (July, 1992).
4.
Schaffer, FM: The Pharmacology and Clinical Application of the New Generation of Antihistamine Agents. 16
International Allergy and Immunology Meeting, Toronto, (July, 1993).
5.
Schaffer, FM, Laxer, RM, Silverman, ED, Allen, C, Shanahan, TC, and O’Neil, KM: Specific Extended MHC
Haplotypes Associated with the Cytokine Regulatory Disorder of Systemic Onset Juvenile Arthritis. American
College of Rheumatology National Meeting, San Antonio (Nov., 1993).
6.
O’Neil, KM, Laxer, RM, Silverman, ED, and Schaffer, FM: Regulatory Disorder of Cytokine Production in
Systemic Onset Juvenile Arthritis. American College of Rheumatology National Meeting, San Antonio (Nov.,
1993).
7.
Schaffer, FM: The Office Work-up of Suspected Immunodeficiency Disorders. 17 International Allergy and
Immunology Meeting, Toronto, (July, 1994).
8.
Schaffer, FM, Shanahan, TC, and Bernstein, JM: Extended MHC haplotypes and Sensorineural Hearing
Disorders. American College of Allergy and Immunology National Meeting, San Francisco (Nov., 1994).
9.
Schaffer, FM: Regulatory Disorder of Cytokine Production in Systemic Onset Juvenile Arthritis: Association with
Specific Extended MHC Haplotypes. Invited Research Conference Speaker – Pediatric Division of Allergy,
Immunology, and Pulmonology – L.S.U. Medical School (Shreveport: June, 1994).
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10. Schaffer, FM: Extended MHC Haplotypes in Sensorineural Hearing Disorders: Genetics and Clinical
Implications. Invited Research Conference Speaker – Mississippi State University, Dept. Biochemistry and
Molecular Biology (Feb., 1996).
ABSTRACTS AND PRESENTATIONS
1.
Laxer, RM, Schaffer, FM, Roberts, EA: Liver involvement in neonatal lupus erythematosus. Society for Pediatr.
Res., Sept. 1985.
2.
Schaffer, FM, Silverman, E, Stein, L, Duffy, C, Gelfand, E, Cameron, B, and Laxer, R. Immunological studies in
Kawasaki disease. Arth Rheum Jan., 1986.
3.
Schaffer, FM, Petsche, D, Benedict, SH, and Gelfand, EW: Down-regulation of slgM by recombinant interferon
and phorbol esters. Fed. Proc. 45:248, 1986.
4.
Estrov, Z, Schaffer, FM, Cohen, A, Gelfand, EW, and Freedman, MH: Non-cytotoxic biologicals as anti-cancer
agents: synergistic anti-proliferative effects of deferoxamine and interferon. Blood 68:222A, 1986.
5.
Schaffer, FM, Koren, G, Silverman, E, Gelfand, E, and Laxer, R. Acute changes in bioavailability and clearance
rate of ASA in Kawasaki disease. Pediatr. Res. 20:209A, 1986.
6.
Schaffer, FM, Benedict, SH, Petsche, D, Lau, AS, Williams, RGB, Mills, GB, and Gelfand, EW: Phorbol esters and
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interferon down-regulate sigM by independent pathways. 6 International Congress of Immunology. July,
1986.
7.
Roifman,CM, Schaffer, FM, and Gelfand, EW: High dose versus low dose intravenous gammaglobulin: A crossth
over study in patients with antibody deficiency and sinopulmonary disease. 6 International Congress of
Immunology. July, 1986.
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8.
Schaffer, FM, Kay, NE, Burrows, P, and Cooper, MD: Studies of the role of the C3d receptor (CR2) in B cell
proliferation. Fed. Proc. May, 1988.
9.
Cooper, M, Miyawaki, T, Chevailer, A, Crain, M, Feng, L, Schaffer, FM, Butler, J, and Kubagawa, H: EBV
transformation and IgA deficiency. International Immunology Meeting, Italy. July, 1988.
10. Zhu, AB, Schaffer, FM, Zhang, L, Palermos, J, Barger, BO, Schroeder, HS, Cooper, MD, and Volanakis, JE: Studies
of MHC genes in IgA deficiency and common variable immunodeficiency. Fed. Proc. May, 1990.
11. Schaffer, FM, McDaniel, DO, Shanahan, TC, Greenberg, SJ, and Laxer, RM: IgA deficiency and polyarticular
juvenile rheumatoid arthritis share extended MHC haplotypes. Fed. Proc. April, 1992.
12. Schaffer, FM, Argawal, R, Gingell, RL, Roland, JMA, and O’Neil, KM: Post-streptococcal reactive arthritis and
silent carditis: The need for Doppler echocardiography and prophylactic antibiotic therapy. Arth. Rheum. Sept.,
1992.
13. Bernstein, J, Lau, K, Shanahan, TC, and Schaffer, FM: Extended MHC haplotypes and sensorineural hearing loss
(Meniere’s disease and Otosclerosis). (AAI/CIS) Fed. Proc. May, 1993.
14. O’Neil, KM, Dempsey, SK, Laxer, RM, Silverman, ED, and Schaffer, FM: Systemic Onset Juvenile Arthritis I.
Regulatory disorder of cytokine production. (AAI/CIS) Fed. Proc. May, 1993.
15. Schaffer, FM, Laxer, RM, Silverman, ED, Lau, K, Shanahan, TC, and O’Neil, KM: Systemic Onset Juvenile Arthritis
II. Association of cytokine regulatory disorder and specific MHC class II and class III genes. (AAI/CIS) Fed. Proc.
May, 1993.
16. Schaffer, FM, Laxer, RM, Silverman, ED, Lau, K, Shanahan, TC, and O’Neil, KM: Specific extended MHC
haplotypes associated with the cytokine regulatory disorder of systemic onset juvenile arthritis. Arth. Rheum.
Nov., 1993.
17. O’Neil, KM, Dempsey, SK, Laxer, RM, Silverman, ED, and Schaffer, FM: Regulatory disorder of cytokine
production in systemic onset juvenile arthritis. Arth. Rheum. Nov., 1993.
18. Schaffer, FM, Shanahan, TC, and Bernstein, JM: Extended MHC hapoltypes and sensorineural hearing loss.
Ann. Allergy. Dec., 1994.
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19. G. Scott, C.M. Bowman , R.B. Pillai, C.A. Little, P.M. Scibielski, A.F. Finn Jr., F.M. Schaffer. Comparative Clinical
Morbidity of an (Autosomal) Agammaglobulinemic female and Bruton’s XLA.L. (AAAAI national meeting) J.
Allergy Clin Immunol., 2004.
20. Schaffer FM, R. Bhanu Pillai, I. Virella-Lowell, C.M. Bowman, R. Tutuian, D.O. Castell.
An Infant with persistent Wheezing due to Non-Acidic Esophageal Reflux. (AAAAI national meeting) J. Allergy
Clin Immunol., 2005.
21. Schaffer FM, Hetherington KA, Shannon R, Hulsey TC, Lewin D, Bhanu Pillai R.
Idiopathic Eosinophilic Esophagitis (EE):Clinical and Histologic Correlates. (AAAAI national meeting) J. Allergy
Clin Immunol., 2005.
22. Schaffer FM, Bhanu Pillai R, Hetherington KA, Shannon R, Hulsey TC, Lewin D, Kubchandani SN, Tolia V.
Eosinophilic Esophagitis (EE): Improved Clinical Responses Without a Concomitant Reduction in Esophageal
Eosinophilic Infiltration (CIS national meeting) Clinical Immunology, 2005.
23. F.M. Schaffer, R.B. Pillai, J.B. Cochran, J.Clark, D.N. Lewin, V. Panzarino, Hans Ochs, T. Torgerson, L.L. Key.
IPEX-Secondary Immunodeficiency Due to the Primary Clinical Syndrome and Therapy. (CIS national meeting)
Clinical Immunology, 2006.
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24. F.M. Schaffer, L.L. Key, J.B. Cochran, T.A. Chatila+, S. Anover, M. Hackett, Hans Ochs, T. Torgerson. IPEX
Syndrome with Normal FOXP3 Coding Region Sequences but Diminished FOXP3 Transcription and
Translation: An Implied FOXP3 Regulatory Gene Defect. (CIS national meeting) Clinical Immunology, 2006.
25. F. M. Schaffer, I. Virella-Lowell, R. A. Gatti, D. L. Gossage. Ataxia-Telangiectasia, Associated with a Rare
1339C>T ATM mutation, presenting in infancy with Pneumocystis carinii pneumonia, and an elevated serum
IgM. (AIA national meeting) J. Immunology, 2007.
26. F. M. Schaffer, B. M. Frankel, E. K. Spicer, M. E. Cavalier. The Autoimmune Lymphoproliferative Syndrome
(ALPS) Associated with a Novel Mutation in Exon 6 of the FAS (TNFRSF6) Gene. (AIA national meeting) J.
Immunology, 2007.
CLINICAL RESEARCH ACTIVITIES
A 52-week, Randomized, Double-Blind, Single-Dummy, Parallel-Group, Multicenter Phase III Study comparing the
long-term safety of XXXX 650/4.5 ug x 4 actuations twice daily to XXXX 160/4.5 ug x 2 actuations twice daily and
XXXX 160 ug x 4 actuations twice daily in adult and adolescent subjects with asthma. 6/30/03
A Twelve-Week, Randomized, Double-Blind, Double-Dummy Trial of XXXX (40/4.5 mcg) versus its Mono-Products
(XXXX) in Asthmatic Children Aged Six to Fifteen Years - SEEDLING 40/4.5 6/27/03
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of XXXX in Patients
with Seasonal Allergic Rhinitis - A Pilot Study During the Fall Season. June 16, 2003
A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study of XXXX Administered Once
Daily in Children and Adolescents 6 to 15 Years of Age with Asthma - SPROUT 6/12/03
A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of XXXX (160/4.5 mcg)
versus its Mono-Products (XXXX) in Adolescents (> 12 Years of Age) and Adults with Asthma-SPRUCE 160/4.5
6/6/03
A Randomized, Partly Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of XXXX (XXXX) at
0.5mg QD, 1.0mg QD, 1.0mg BID, 2.0mg BID and XXXX (XXXX) at 400mcg BID in Adolescents (12 Years of Age and
Older) and Adults with Moderate to Severe Asthma 4/7/03
The Safety and Efficacy of XXXX Extended-Release Tablets in Migraine Prophylaxis: A Double-Blind, PlaceboControlled Study in Adolescents 4/4/03
A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral
XXXX (250mcg or 500 mcg) Daily in Patients with Asthma Final-3/28/03
A Randomized, Double-Blind, Placebo-Controlled Trial of XXXX (XXXX) Nasal Spray 137 mcg at a Dosage of One
Spray per nostril twice daily in patients with Seasonal Allergic Rhinitis 3/24/03
A Multicenter, Double-Blind, Randomized Study Investigating the Clinical Effect of XXXX on Allergic Rhinitis in
Patients with Seasonal Allergic Rhinitis and Chronic Asthma - Spring 2003 Study 3/3/03
A Phase III, Open-Label, Outpatient, Extension Study to assess the long-term safety of a modified release
formulation of XXXX in Adult primary insomnia patients with Sleep Maintenance Difficulties Final Version
A Randomized, Double-Blind, Placebo-Controlled Trial of XXXX (XXXX) nasal spray 137 mcg at a dosage of one spray
per nostril twice daily in patients with seasonal allergic rhinitis 1/20/03
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A Multicenter, Randomized, Double-Blind, Parallel Group, 40-Week comparison of asthma control using bronchial
hyperresponsiveness as an additional guide to long-term treatment in adolescents and adults receiving either XXXX BID or
XXXX BID (or placebo BID if asymptomatic)
A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of XXXX Nasal Spray versus
Placebo in subjects with Perennial allergic rhinitis 11/11/02
A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Study of XXXX
Administered once daily in Adults and Adolescents with Asthma - STEM 9/26/02
A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Three
Dose levels of XXXX in the treatment of Chronic Plaque Psoriasis 9/18/02
Multi-Dose Safety and Tolerance Study of Desloratadine in Atopic Pediatric Subjects and Pediatric Subjects with
Chronic Idiopathic Urticaria, Ages >2 to <12 Years, who are poor metabolizers of XXXX Final- 8/28/02
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to assess the efficacy and safety of a
modified release formulation of XXXX in adult primary insomnia patients with sleep maintenance difficulties
8/12/02
A Placebo- and Active-Controlled Efficacy and Safety Study of a once-daily fixed combination tablet of XXXX
5mg/XXXX 120mg (XXXX [5/120]) in Subjects with Seasonal Allergic Rhinitis Final- 7/16/02
An Open-Label Screening Protocol to Determine the XXXX Metabolic Phenotype of Atopic Pediatric Subjects and
Pediatric Subjects with Chronic Idiopathic Urticaria (Ages >12 to <12 Years) Final- 7/15/02
A Randomized, Double-Blind, Placebo-Controlled Trial of XXXX (XXXX) Nasal Spray, XXXX (XXXX), and XXXX Nasal
Spray plus XXXX (XXXX) in patients with Seasonal Allergic Rhinitis 7/12/02
A Randomized (2:1), Stratified, Double-Blind, Parallel-Group, Placebo-Controlled, 12-Week, Multi-Center Trial of
XXXX 88mcg BID versus Placebo HFA delivered via an MDI and a Valved Holding Chamber with A Multicenter,
Randomized, Double-Blind, Crossover Study comparing the Effect of XXXX and Placebo in Adult patients with
chronic asthma. 5/13/02
A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of XXX vs.XXX in
Pediatric Subjects with Activity-Induced Bronchospasm.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial Designed to
Assess the Efficacy and Safety of XXX Applied as a Nasal Spray at Three Dose Levels (200ug, 100ug, or 25 ug, once
daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 6-11 years of age.
Safety and Efficacy Evaluation of Two Doses of XXX vs Placebo by Breath Operated and Metered Dose Inhalers in
Moderate Asthmatic Adolescents and Adults on a Stable Regimen of Inhaled Corticosteroids
A Multi-Center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Phase II Study to Assess the Efficacy
and Safety of XXX Nasal Spray, 16ug, 32ug, and 64ug per day versus placebo in Pediatric Subjects, Ages 2-5 years
Old With Allergic Rhinitis.
The Safety and Efficacy of XXX in Migraine Prophylaxis: A Double-Blind, Placebo-Controlled Study in Adolescents.
A Placebo Controlled Study of the Efficacy and Safety of XXX vs. XXX 180 mg. in the treatment of subjects with
Symptomatic Seasonal Allergic Rhinitis (SAR)
Randomized, Double-Blind Trail of XXX Nasal Spray Compared to XXX in Patients with Seasonal Allergic Rhinitis.
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A Multicenter, Randomized, Double-Blind, Crossover Study Comparing the Effect of XXX with Placebo and
Concomitant Administration of XXX Plus XXX in Adult Patients with Chronic Asthma.
A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures
of Airway Inflammation in Subject of African Descent Receiving XXX BID or XXX BID Alone.
A Phase III, Investigator-Blind, Randomized, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy
of XXX for 7 Days Compared to XXX for 10 days in the Treatment of Tonsillitis and or Pharyngitis Secondary to
Streptococcus Pyogenes in Pediatric Patients. 1/2005
A placebo-and active-controlled XXX, randomized, parallel-group, dose-range finding study of XXX administered by
dry powder inhaler (Ultrahaler) in adult and adolescent patients with persistent asthma. 2/2005
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and
Efficacy of Once-Daily, Intranasal Administration of XXX Aqueous Nasal Spray 50mcg and 100mcg for 12 Weeks in
Pediatric Subjects Ages 2 to 12 Years with Perennial Allergic Rhinitis (PAR) 2/2005
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and
Safety of Once-Daily, Intranasal Administration of XXX Aqueous Nasal Spray 100 mcg for 4 weeks in Adult and
Adolescent Subjects (>12 years of age ) with Vasomotor/Idiopathic Rhinitis) 2/2005
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and
Safety of Once-Daily, Intranasal Administration of XXX Aqueous Nasal Spray 50 mcg and 100 mcg for 2 Weeks in
Pediatric Subjects Ages 2 to <12 Years with Seasonal Allergic Rhinitis (SAR) 2/2005
Safety and Efficacy of XXX Nasal Spray in Pediatric Patients 2/2005
A Double-Blind, Placebo –Controlled Evaluation of the Safety of Topically Applied XXX in Comparison to Oral XXX
for the Treatment of the Signs and Symptoms of Osteoarthritis of the Knee 6/2005
A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of XXX
metered-dose inhaler at a daily dose of 160 ug administered for 12 weeks either in a once-daily regimen in the
morning (160 ug qd Am) or in a twice-daily regimen (80 ug bid) in adults and adolescents with mild to moderate
persistent asthma treated previously with inhaled corticosteroids. 7/2005
Safety and Efficacy Study of XXX Nasal Spray 665 mcg versus XXX Nasal Spray Vehicle versus XXX in Treatment of
Seasonal Allergic Rhinitis 9/2005
A multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the
efficacy of XXX metered-dose inhaler at a daily dose of 160 ug qd administered either in a once-daily in the
morning regimen (160 ug qd AM) for 16 weeks or in a 160 ug qd AM regimen for 12 weeks preceded by a twicedaily regimen (80 ug bid) for 4 weeks, or in an 80 ug bid regimen for 16 weeks, in adults and adolescents with mild
to moderate persistent asthma not treated with steroids. 11/2005
A Randomized, Parallel Group, Double-Blind, Comparative Trail Assessing Lung Function and Other Measures of
Asthma Control in Adults and Adolescents, at least 12 years of Age, with Persistent Asthma, Who Have Either a
B16Arg/Arg, a B16- Gly/Gly or a B-16Arg-Gly Genotype and are treated with XXX or XXX. 11/2005
A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and
Efficacy of XXX in Subjects with Persistent Asthma. 11/2005
Efficacy and Safety of Combination XXX vs. XXX and Placebo in the Treatment of Subjects with Seasonal Allergic
Rhinitis.
Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of XXX in Patients with seasonal
Allergic Rhinitis.
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A Multicenter, Double-Blind, Placebo Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect
of oral XXX versus Placebo in Persistent Asthma Which is Also Active During Allergy Seasons in Pediatric Patients
with Seasonal Aeroallergen Sensitivity.
A Multicenter, Randomized, Open-Label Study to Assess the Functionality of XXX with an Actuation Counter during
use by Children, Adolescents, and Adults with Stable, Inhaled Corticosteroid-Dependent Asthma.
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and
Efficacy of XXX Applied as a Nasal Spray for Two Weeks in the Treatment of Seasonal Allergic Rhinitis (SAR) in
Patients 6 to 11 Years of Age.
A 6-month Randomized, Double-Blind, Parallel-Group, Multicentre, Placebo-Controlled Phase II Study to Compare
Anti-Asthmatic Effect and Safety of XXX 40 mg twice daily or 40 mg. once daily with Placebo in Adults with Asthma.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 8-Week Study to Evaluate the
Efficacy and Safety of Chewable XXX When Initiated at the Start of the School Year in Pediatric Patients with
Asthma.
A 21 Week Single-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XXX as a Treatment for
Chronic Autoimmune Urticaria.
Efficacy and Safety of XXX in Subjects with Symptoms of Seasonal Allergic Rhinitis: A Randomized, Double-Blind,
Placebo-Controlled, Comparative, Multi-Center, Parallel Groups Study.
Double-Blind Multi-Centre, Placebo-Controlled, Clinical Study to Evaluate the Clinical Equivalence of 128 mcg of
XXX Nasal Spray (Apotex, Inc., Canada) vs. 128 mcg of XXX Nasal Spray (AstraZeneca, USA) for the Indication of
Seasonal Allergic Rhinitis. 10/2006
A Placebo-Controlled Study of the Effects of XXX Nasal Spray on Common Cold Symptoms and Asthma
Exacerbations Following Rhinovirus Exposure. 11/2006
Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and XXX Inhalation Powder
500mcg Twice Daily Compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma
Symptomatic on Moderate
Dose ICS Therapy.
A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study
to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and XXX Inhalation Powder
250mcg Twice Daily Compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma
Symptomatic on Low-Dose ICS Therapy.
A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study
to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and XXX Inhalation Powder
100mcg Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma
Symptomatic on Non-Steroidal, Asthma Therapy.
Multi-center, Randomized, Double Blind, Placebo Controlled Parallel Group Study of the Safety of XXX Oral Liquid
Formulation b.i.d. dosing in Children Aged 2 to 6 Years Suffering from Allergic Rhinitis or Chronic Urticaria of
Unknown Origin.
Randomized, Double-Blind Trial of XXX Nasal Spray Compared to Placebo, XXX Nasal Spray, and XXX Nasal Spray in
the Treatment of Patients with Seasonal Allergic Rhinitis.
A multi-center, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and
impact on health-related quality of life of XXX 5 mg once daily given for 2 weeks in subjects 18 yr of age and older
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with seasonal allergic rhinitis.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of XXX in Adult Migraineurs for a
Single Migraine Followed by Open-Label Extensions to 26/52 Week
A 12-week, randomized, double-blind, double dummy, multi-center, phase IV study comparing the efficacy and
safety of XXX pMDI 106/4.5 µg x 2 actuations twice daily versus XXX inhalation powder DPI 180 µg x 2 inhalations
twice daily, in adult and adolescent (≥12 years) African American subjects with asthma.
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of XXX in
the Treatment of Seasonal Allergic Rhinitis
Randomized, Double-Blind Trial of XXX Nasal Spray Compared to Placebo, XXX Nasal Spray, and XXX Nasal Spray in
the Treatment of Patients with Seasonal Allergic Rhinitis
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Two- Year Study to Evaluate the
Ocular Safety of Once-Daily, XXX Nasal Spray in Adults and Adolescents 12 Years of Age and Older with Perennial
Allergic Rhinitis
Placebo-Controlled Study of XXX Nasal Spray QD in the Relief of Nasal Congestion Associated with Seasonal Allergic
Rhinitis (SAR)
Safety and Pharmacokinetics of XXX in Pediatric Patients 2 to <6 Years of Age Who Have a History of Allergic
Rhinitis
Randomized, Double-Blind Trial of XXX Nasal Spray Compared to Placebo, XXX Nasal Spray and XXX Nasal Spray in
the Treatment of Patients with Seasonal Allergic Rhinitis
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Range-Finding Study to Assess
the Efficacy and Safety of XXX Nasal Aerosol in Adult and Adolescent Patients (12 Years and Older) with Seasonal
Allergic Rhinitis (SAR)
A Double-Blind, Placebo-Controlled Extension to the Study of XXX in Adult Patients with Chronic Asthma (Extension
to Protocol 007)
A Phase 4, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Tolerance of XXX in
Subjects with Asthma or Chronic Obstructive Pulmonary Disease
A Phase II, Multicenter, Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of XXX In Patients with
Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic with Antihistamine Treatment (H1); 6/2009
A 52-week treatment, randomized, double-blind, placebo-controlled, with open label XXX, parallel-group study to
assess the efficacy, safety and tolerability of XXX in patients with chronic obstructive pulmonary disease. 20092010.
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