Ongoing Trials 

Investigators-  G. Wendell Richmond, M.D. (Principal),  Mark C. Jacobson, M.D.                                                               

Efficacy, Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human), 10% (Gammagard Liquid) Administered Intravenously or Subcutaneously Following Administration of Hyaluronidase (rHuPH20) in Subject with Primary Immunodeficiency Diseases:  Baxter Protocol No. 160603 2009.

Pharmacosurveillance Data repository of patients with and without history of anapyhlactic reactions subsequent to  Xolair Dosing: Protocol Number: Q4458g.  Genentech  2009.

Completed Trials:

Investigator- G.Wendell Richmond, M.D.

Oral and intravenous gamma globulin administration in a bone marrow transplant population.    Baxter Health Care, Hyland Therapeutics Division,1987-1989.                                                                             

Auranofin versus placebo in the treatment of steroid-dependent asthma.  SKF 1991-1992.               

An open multi-site study of the safety and efficacy of cetirizine in allergic rhinitis. Pfizer 1992.

Validation of quality of  life questionnaire in asthma using Vanceril.  Schering Plough Corp.  1993.

Onset of action of vancenase AQ versus placebo in seasonal allergic rhinitis. Schering-Plough Corp. 1993.

A comparison of the safety, tolerance, efficacy and biological half life of Gammar IV and Pasteurized Gammar IV for replacement therapy in patients with common variable and sex-linked hypogammaglobulinemia.  Rhone-Poulenc-Rorer. 1993-1994.

Efficacy of Claritin versus Seldane versus placebo upon awakening in spring seasonal allergic rhinitis.  Schering-Plough Corp. 1994.

A Phase II Trial:  Venoglobulin-I (10%) in the treatment of severe, steroid-dependent asthma, atopic dermatitis and Hyper-IgE syndrome.  Alpha Therapeutic Corporation. 1993-1996.

 Venoglobulin-S (5%) as a prophylaxis agent acute graft-versus host disease after  allogenic bone marrow transplantation.  AlphaTherapeuticsCorporation.1991-1996.

A comparison of the safety, tolerance and biological half-life of RPR 109413  and Gaminune N (10% solutions) for replacement therapy in patients with primary or secondary immune deficiency.       Rhone-Poulenc-Rorer. 1995.

A clinical investigation to assess the acute safety and pharmacokinetics of liquid    immunoglobulin intravenous (human) in patients with primary immune deficient disease.  Baxter Healthcare Corp., Hyland Division. 1995.

 A phase 4 study to assess the acute and medium term safety of Gammagard S/D in patients with primary immune deficient disorders.  Baxter Healthcare Corp., Hyland Division. 1996.

A multi-center, randomized, double-blind, placebo-controlled, study evaluating the effect of montelukast sodium compared to inhaled beclomethasone dipropionate in adult asthmatics.  Merck & Co. Inc. 1997.     

A clinical investigation to assess the pharmacokinetics and acute safety of  immunoglobulin intravenous (human) 5% solutions in patients with primary immunodeficiency disorders.  Baxter, 1998.

 Evaluation of Xopenex (levalbuterol) inhalation solution in the treatment of asthma. Sepracor, 1998.

 A placebo-controlled and safety study of the mometasone furoate HFA-227 metered dose inhaler administered QD PM vs. bid in the treatment of asthma in subjects previously maintained on short-acting beta-agonists.  Schering-Plough. 1999.

 A randomized, double-blind, multi-center parallel group trial comparing the safety and efficacy of IGIV-Chromatography, 10% (experimental) with IGIV-solvent detergent treated, 10% (control) in patients with primary immune deficiency (PID). Bayer, 1999.

 A multi-center, double-blind randomized parallel-group study investigating the clinical effect of L858674 in patients with seasonal allergic rhinitis, a pilot study during the fall season.  Merck. 2000.

A phase 2/3 open-label, prospective multicenter study of the pharmacokinetics, efficacy, safety, and tolerability of Immune Globulin Subcutaneous, (human) CE 1200 in subjects with primary immune deficiency.   Aventis. 2001.

An observational study of the epidemiology and natural history of

asthma; Outcomes and treatment regimens  (Tenor). Genentech 2001.

 A multi-center, double-blind, randomized, parallel-group study investigating the clinical effect of Montelukast in patients with seasonal allergic rhinitis over a 4-week treatment period-fall 2001.  Merck.  2001.

A multicenter, randomized, controlled, open-label study to evaluate the safety of Omalizumab in moderate to severe, persistent asthma subjects already treated with other therapies (ALTO). Protocol 2143g.  Genentech. 2001.

Open-label extension study II of XolairÔ (Omalizumab) in moderate to severe, persistent asthma subjects who completed study Q2143g. Protocol 2461g. Genentech.  2002.

 A phase III double-blind, double-dummy, parallel-group, multicenter, placebo-controlled, efficacy and safety study of ciclesonide MDI 400mG/day, 800 mG/day (ex-valve) and FloventÒ MDI (fluticasone propionate) 880 mG/day (ex-actuator) administered twice daily for 12-weeks in the treatment of severe persistent asthma in adolescents and adults. Aventis.  2002.

Protocol By217/FK1 021: 12 weeks treatment with 125 mg roflumilast versus 250 mg roflumilast versus placebo in patients with asthma. Byk Gulden. 2002.