Apply to Graduate School | Library | Jobs & Volunteers | Visitor Information | Department Index | News      
Center for Human Genomics at Wake Forest University School of Medicine

Completed Studies:

8/00 - 8/01                  Genentech, A multicenter, randomized, controlled, open label study to evaluate the safety of Xolair in moderate to severe persistent asthma subjects already treated with other therapies.

3/01-9/01                    GlaxoSmithKline, An open label, 12 week study to evaluate the effects of a corticosteroid sparing dose of salmeterol/fluticasone propionate combination product 50/100mcg BID via the DISKUS inhaler on airway inflammation, airway remodeling, and bronchial hyperresponsiveness.

2002 -                          Genentech, An open-label extension study of Xolair (Omalizumab) in moderate to severe, persistent asthma subjects who completed study.

2002 -                          Novartis, A phase III, 28 week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of subcutaneous omalizumab adult and adolescent patients with high risk severe persistent allergic asthma who remain symptomatic despite optimal therapy.

9/01 - 12/02                GlaxoSmithKline, A multicenter, randomized, double-blind, double-dummy, parallel-group comparison of salmeterol xinafoate inhalation versus ipratorpium and albuterol sulfate inhalation aerosol in subjects with chronic obstructive pulmonary disease.

12/01 - 1/03                GlaxoSmithKline, A randomized, double-blind, double-dummy, parallel group, comparative clinical trial evaluating Fluticasone propionate/salmeterol xinofoate (250/50mcg BID via DISKUS) to ipratropium bromide/albuterol sulfate (36/206mcg QD) inhalation aerosol in subjects with chronic obstructive pulmonary disease (COPD).

5/01 - 5/03                  Millennium, A Phase II, randomized, placebo controlled, double-blind, parallel group, dose-finding study to evaluate the effectiveness of 28 days of treatment with LDP-977 in adult asthmatics.

9/01 - 9/03                  Bayer, A randomized, double-blind study to compare the safety and efficacy of 20 mg of Bay 16-9996 versus placebo as adjunctive therapy for corticosteroids for corticosteroid therapy in patients with severe asthma,.

2/01 - 1/04                  Genentech, An observational study of the epidemiology and natural history of asthma: Outcomes and treatment regimens (TENOR).

9/02 - 1/04                  Boehringer Ingelheim, A comparison of ipratropium bromide/ salbutamol delivered by the Respimat® inhaler to ipratropium bromide Respimat®, COMBIVENT® Inhalation Aerosol and Placebo of each formulation in a 12‑week, double‑blind, safety and efficacy study in adults with chronic obstructive pulmonary disease.

10/02 - 1/04                Boehringer Ingelheim, A randomized, double-blind, double-dummy, placebo-controlled, crossover efficacy and safety comparison of 4 week treatment periods of two doses [5ug (2 actuations of 2.5ug)] and 10ug (2 actuations of 5ug)] of Tiotropium inhalation solution delivered by the Respimat inhaler, Tiotropium inhalation powder delivered by the Handihaler in patients with chronic obstructive pulmonary disease.

4/03 - 6/04                  Pfizer, A 24 week, placebo-controlled, randomized, parallel group study comparing Roflumilast 500 mcg daily vs. placebo on pulmonary function and respiratory symptoms in patients with chronic obstructive pulmonary disease (COPD).

10/03 - 6/04                Altana, A randomized, controlled study of roflumilast (250 mcg and 500 mcg) versus placebo in patients with asthma.  A 24-week, multicenter, multinational, double-blind, parallel group clinical study.

9/03 - 9/04                  Centocor, A phase II, multi-center, randomized, double-blind, placebo controlled parallel group dose finding study evaluating the safety and efficacy of Infliximab administration in symptomatic subjects with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

11/02 - 11/04              Astra Zeneca, A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Placebo-and-Active-Controlled Study of SYMBICORT pMDI Administered Once Daily in Adults and Adolescents with Asthma (STEM).

11/02 - 11/04              Astra Zeneca, A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Active Controlled Study of SYMBICORT®_ pMDI Administered Once Daily in Children and Adolescents 6 to 15 Years of Age with Asthma _ SPROUT.

12/01 - 12/04              GlaxoSmithKline, A Randomized, Double-Blind 12-Week Comparative Trial of Fluticasone Propionate DISKUS 100mcg BID Versus Fluticasone Propionate DISKUS 100mcg and Oral Montelukast 10mg QD in Adults with Persistent Asthma.

2001 - 2005                 GlaxoSmithKline,  A multi-center, 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 fluticasone propionate/ salmeterol Diskus BID or fluticasone propionate Diskus BID (or placebo BID if asymptomatic).

8/04 - 9/05                  Novartis, A randomized, double-blind, placebo-controlled, parallel group, multi-center, multiple dose (7 days) dose ranging study, to assess the efficacy and safety of 4 doses of QAB149 (400 μg) delivered via a single dose inhaler, in adult and adolescent patients (12-75 years old inclusive) with stable, persistent asthma.

4/03 - 12/05                Novartis, A randomized, multicenter, placebo-controlled parallel group study of four months duration per patient to evaluate the safety and efficacy of treatment with 24µg b.i.d. and 12µg b.i.d. formoterol, double-blind, and 12µg b.i.d. formoterol with additional on-demand formoterol doses, open-label, in adolescent and adult patients with persistent stable asthma.

12/03 - 12/05              Altana, Effects of roflumilast on exacerbation rate in patients with chronic obstructive pulmonary disease.

8/04 - 12/05                Novartis, A randomized, double-blind, placebo-controlled, parallel group, multi-center, multiple dose (7 days) dose ranging study, to assess the efficacy and safety of 4 doses of QAB149 (50, 100, 200 & 400 μg) delivered via a multiple dose inhaler and 1 dose of QAB149 (400 μg) delivered via a single dose inhaler in patients with chronic obstructive pulmonary disease (COPD 02205).

12/04 - 8/06                Astra Zeneca, SHINE (D5899C00002): A 6-Month, Double-blind, Double-dummy, Randomized, Parallel group, Multicenter Efficacy and Safety Study of SYMBICORT® pMDI 2 x 160/4.5 mcg and 2 x 80/4.5 mcg bid Compared to Formoterol TBH, Budesonide pMDI (and the combination) and Placebo in COPD Patients.

9/02 - 9/06                  Boehringer Ingelheim, A randomized, double-blind, placebo-controlled, parallel group trial assessing the rate of decline of lung function with tiotropium 18 mcg inhalation capsule once daily in patients with chronic obstructive pulmonary disease (COPD).

8/05 - 9/06                  Boehringer Ingelheim, A Randomized, Multiple-dose, Double-Blind, Crossover Study to Compare the Efficacy and Safety of 200 mcg and 400 mcg of BEA 2180 BR to Tiotropium 5 mcg and Placebo when each is delivered by the Respimat Inhaler in patients with Chronic Obstructive Pulmonary Disease (COPD).