Previous Clinical Trials

CARDIOVASCULAR:
Hyperlipidemia
Jan 2006 - Sep 2006Sub-Investigator - A Phase 3, Open Label, Multi-Site, Randomized, Parallel-Group Study of the Efficacy and Safety of a Fixed Combination CETP Inhibitor-Statin Combination Administered Once Daily (qd) Compared to a Statin Alone for 6 Weeks in Subjects with Hypercholesterolemia.
Hypertension
Mar 2016 - May 2017Principal Investigator -“Multi-center, double-blind, double-dummy, randomized, placebo- and active-reference, parallel group, Phase 2 dose-finding study with ACT-132577 in subjects with essential hypertension (grade 1 and 2)”
Sep 2009 - Feb 2011Principal Investigator - A Phase 3, Open-Label, Randomized, Long-Term Comparison of the Safety and Tolerability of the TAK-491 Plus Chlorthalidone Fixed-Dose Combination Versus Olmesartan Medoxomil-Hydrochlorothiazide Fixed-Dose Combination in Subjects with Essential Hypertension.
Feb 2009 - Feb 2010Principal Investigator - A Phase 3, Double-Blind, Randomized, Efficacy and Safety Study of the TAK-491 Plus Chlorthalidone Fixed-Dose Combination Compared with TAK-491 and Hydrochlorothiazide Coadministration Therapy in Subjects with Moderate to Severe Essential Hypertension.
Oct 2008 - Apr 2009Principal Investigator - A Phase 3, Double-Blind, Randomized, Efficacy and Safety Study of the TAK-491 Plus Chlorthalidone Fixed-Dose Combination Compared with TAK-491 and Hydrochlorothiazide Coadministration Therapy in Subjects with Moderate to Severe Essential Hypertension.
Apr 2008 - Jul 2009Principal Investigator - An 8-Week Randomized, Double-Blind, Parallel-Group, Multicenter, Active-Controlled Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to HCTZ (25 mg) in Older Patients with Stage 2 Systolic Hypertension.
ENDOCRINE:
Diabetes
Jan 2017 - Jun 2019Principal Investigator- PIONEER 6- Cardiovascular outcomes A trial investigating the cardivascual safety of oral semaglutide in subjects with type 2 diabetes
Oct 2014 - May 2015Principal Investigator - Efficacy and safety of semaglutide once-weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes
Feb 2014 - Dec 2016Principal Investigator - A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects with Type 2 Diabetes at High Risk of Cardiovascular Events.
May 2011 - Jun 2019Sub-Investigator - A Multicenter, International, Randomized, Parallel-Group, Double-Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients with Type 2 Diabetes Mellitus at High Cardiovascular Risk.
Oct 2011 - Feb 2014Principal Investigator - A 6-Month, Multicenter, Randomized, Open Label, Parallel-Group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus Both Plus Mealtime Insulin in Patients with Type 2 Diabetes Mellitus with a 6-Month Safety Extension Period.
Oct 2011 - Feb 2014Principal Investigator - A 6-Month, Multicenter, Randomized, Open Label, Parallel-Group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus Both in Combination with Oral Antihypergylcemic Drug(s) in Patients with Type 2 Diabetes Mellitus with a 6-Month Safety Extension Period.
Oct 2010 - Aug 2012Principal Investigator - An Open Label, Randomized, Multicenter Study to Assess Patient Preference For and Evaluate Clinical Benefit of Insulin Glargine (Lantus®) SoloSTAR® Pen Versus Conventional Vial/Syringe Method of Insulin Glargine (Lantus®) Injection Therapy in Patients with Type 2 Diabetes Mellitus. 
Mar 2009 - Jan 2013Sub-Investigator - A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination with Metformin in Subjects with Type 2 Diabetes. 
Feb 2008 - Jun 2008Principal Investigator - A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 12-Week Administration of PF-00734200 to Subjects with Type 2 Diabetes Mellitus and Insufficient Glycemic Control on Metformin Treatment.
Nov 2007 - Jul 2008Sub-Investigator - A Phase 2A, Randomized, Placebo-Controlled, Parallel-Group, Multiple-Dose Study to Evaluate the Efficacy, Safety and Tolerability of 12-Week Oral Administration of PF-00734200 Tablets to Subjects with Type 2 Diabetes Mellitus on Stable Treatment with Metformin.
Nov 2006 - Nov 2007Principal Investigator - Repaglinide and Metformin Combination Tablet (NN4440) in a tid Regimen Compared to a bid Regimen and bid Avandamet in Subjects with Type 2 Diabetes:  A 26-Week, Open Label, Multicenter, Randomized, Parallel-Group Trial to Investigate Efficacy and Safety.
Oct 2006 - Dec 2007Sub-Investigator - A Two-Week, Randomized, Modified-Blind, Double-Dummy, Parallel-Group Efficacy and Safety Study of Arformoterol Tartrate Inhalation Solution Twice-Daily, Tiotropium Once-Daily, and Arformoterol Tartrate Inhalation Solution Twice-Daily and Tiotropium Once-Daily (Dosed Sequentially) in Subjects with Chronic Obstructive Pulmonary Disease.
Sep 2006 - Jul 2007Sub-Investigator - Effects of NovoLog® Mix 70/30 (Biphasic Insulin Aspart 70/30) bid and qd vs. Byetta ™ (Exenatide) bid on Glycemic Control:  A Multicenter, 24-Week, Open Label, Parallel-Group Study in Patients with Type 2 Diabetes Mellitus Not Achieving Glycemic Targets with Metformin and a Sulfonylurea.
May 2006 - Jan 2013Sub-Investigator - A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR110322 (SYR322) in Subjects with Type 2 Diabetes.
May 2006 - Jul 2007Sub-Investigator - One Versus Two Versus Three Daily Rapid-Acting Insulin Injections as Add-On to an Oral Sensitizer Basal Therapy in Type 2 Diabetes:  A Multicenter, Randomized, Parallel-Group, Open Label Clinical Study.
Apr 2006 - May 2009Sub-Investigator - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy and Safety of Long-Term Administration of Rimonabant in the Prevention of Type 2 Diabetes in Patients with Pre-Diabetic Status (i.e., Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT), or Both).
Apr 2006 - Aug 2007Sub-Investigator - A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of the Combination of an Oral Glucose Lowering Agent Compared to Pioglitazone HCl (ACTOS®) in Subjects with Type 2 Diabetes with Optional Open Label Extension.
Apr 2006 - Aug 2007Sub-Investigator - A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of an Oral Glucose Lowering Agent Compared to Placebo in Subjects with Type 2 Diabetes with Optional 9 Month Open Label Extension.
Apr 2006 - Aug 2007Sub-Investigator - A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of an Oral Glucose Lowering Agent When Used in Combination with a Pioglitazone in Subjects with Type 2 Diabetes with Optional 9 Month Open Label Extension.
Apr 2006 - Aug 2007Sub-Investigator - A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of an Oral Glucose Lowering Agent When Used in Combination with a Sulfonylurea in Subjects with Type 2 Diabetes with Optional 9 Month Open Label Extension.
Jan 2006 - Sep 2008Sub-Investigator - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 13-Week, Adaptive-Design Study of 4 Fixed Oral Doses of an SNRI in Adult Outpatients with Pain Associated With Diabetic Peripheral Neuropathy with Optional 9 Month Open Label Extension.
GASTROINTESTINAL:
Clostridium Difficile 
Mar 2017 - Jun 2019Principal Investigator - A Phase 3, multicentre, randomized, double-blind, placebo-controlled, study investigating the efficacy and safety of daily oral administration of OBE2109 alone and in combination with add back therapy for the management of heavy menstrual bleeding associated with uterine fibroids in menopausal women.
Mar 2015- Aug 2018 Principal Investigator - Efficacy, Immunogenicity and Safety Study of Clostridium difficile Toxoid Vaccine in Subjects at Risk for C. difficile Infection
IBS 
Sep 2016- May 2017 Sub-Investigator- A 26-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
Mar 2016 - Sep 2017Sub-Investigator - A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study with a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
Mar 2014 - Aug 2015Principal Investigator - A 12-Week Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 3 Study, Followed by a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Oral Ibodutant 10 mg Once Daily in Female Patients with Irritable Bowel Syndrome with Diarrhea (IBS-D).
May 2013 - Sep 2014Sub-Investigator - A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients with Diarrhea-Predominant Irritable Bowel Syndrome. 
Jan 2013 - Sep 2013Sub-Investigator - A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C).
May 2012 - Jan 2014Sub-Investigator - A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients with Diarrhea-Predominant Irritable Bowel Syndrome. 
GYNECOLOGICAL / WOMEN'S STUDIES:
Dysmenorrhea
Feb 2013 - Aug 2015 Sub-Investigator - A Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Further Assess the Efficacy, Safety and Dose Response of KYG0395 in the Treatment of Primary Dysmenorrhea. 
Endometriosis
Jan 2015 - Jul 2017Sub-Investigator- Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis Associated Pain
May 2014 - Dec 2016 Sub - Investigator -A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain.
May 2013 - Apr 2016Sub Investigator - Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain. 
Jun 2012 - Dec 2015Sub-Investigator- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain. 
Fibroids
Aug 2010 - Jun 2011Sub-Investigator - A Hysteroscopic Office Myomectomy Evaluation Using the MyoSure™ Tissue Removal System for the Removal of Uterine Fibroids and Polyps in the Treatment of Abnormal Uterine Bleeding.
Jul 2008 - Jan 2010Sub-Investigator - A Phase 3, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 and 50 mg Proellex (CDB-4124) in the Treatment of Premenopausal Women with Symptomatic Uterine Fibroids. 
Hypoactive Sexual Desire Disorder
Nov 2010 - Mar 2012Sub-Investigator - A Phase 3, Multicenter Extension Study to Assess Persistence of Benefit of LibiGel® for the Teatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women.
Aug 2008 - Oct 2012Sub-Investigator - A Phase 3, Multicenter Extension Study to Assess Persistence of Benefit of LibiGel® for the Teatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women.
Aug 2008 - Mar 2012Sub-Investigator - A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women. 
Menopause
Apr 2015 - Jan 2016Sub-Investigator - Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial to Evaluate the Safety and Efficacy of HR TX-004HR in Postmenopausal Women with Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy.
Apr 2011 - Mar 2012Sub-Investigator - A Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Mesafem (Paroxetine Mesylate) Capsules in the Treatment of Vasomotor Symptoms Associated with Menopause.
Aug 2010 - Oct 2011Sub-Investigator - A Phase 3, 24-Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Mesafem (Paroxetine Mesylate) Capsules in the Treatment of Vasomotor Symptoms Associated with Menopause.
Jan 2009 - Jan 2011Sub-Investigator - A Double-Blind, Randomized, Placebo- and Active-Controlled Efficacy and Safety Study of the Effects of Bazedoxifene / Conjugated Estrogens Combination on Endometrial Hyperplasia and Prevention of Osteoporosis in Postmenopausal Women.  
Jul 2008 - Sep 2009Sub-Investigator - Efficacy and Safety of Ospemifene in the Treatment of  Moderate to Severe Vaginal Dryness and Vaginal Pain Associated with Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated with Menopause:  A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Daily Dose with Placebo in Postmenopausal Women.
May 2008 - Aug 2010Sub-Investigator - A Double-Blind, Randomized, Placebo-Controlled Study Assessing the Safety and Efficacy of DVS SR for the Treatment of Vasomotor Symptoms Associated with Menopause.
IMMUNOLOGICAL:
Dust Mite
May 2013 - Jul 2015Sub-Investigator - A 1-Year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite Induced Allergic Rhinitis/Rhinoconjunctivitis with or without Asthma.  
Grass Pollen
May 2011 - Nov 2012Sub-Investigator - A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum Pratense) Sublingual Tablet (SCH 697243) in Subjects Between 5 and 65 Years of Age, With a History of Grass Pollen-Induced Rhinoconjunctivitis, with or without Asthma.
Ragweed
Oct 2009 - Jul 2011 Sub-Investigator - A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects with a History of Ragweed-Induced Rhinoconjunctivitis with or without Asthma.
INFECTIOUS DISEASE:
Influenza
Sep 2013 - Sep 2014Sub-Investigator - A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide and Nitazoxanide Plus Oseltamivir in the Treatment of Acute Uncomplicated Influenza.
MUSCULOSKELETAL:
Arthritis
Mar 2008 - Jan 2011Sub-Investigator - A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-α Therapy.
Mar 2008 - Jun 2009Sub-Investigator - A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab in Combination with Methotrexate Compared to Methotrexate Alone in Methotrexate-Naïve Patients with Active Rheumatoid Arthritis.
May 2007 - May 2009Sub-Investigator - A Phase 3, 53-Week Study on Analgesic Efficacy and Safety of Naproxcinod (HCT 3012): 26-Week, Randomized, Parallel-Group, Double-Blind, Placebo (13 Weeks)- and Naproxen (26 Weeks)-Controlled, Multicenter Study of Naproxcinod (375 mg bid and 750 mg bid) with a 26-Week Naproxen-Controlled Safety Follow-Up in Subjects with Osteoarthritis of the Knee, and a 1-Week Post-Treatment Safety Follow-Up.
Jun 2005 - Feb 2006Sub-Investigator - An 8-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of an Anti-Inflammatory in Patients with Primary Osteoarthritis of the Hand.
Gout
Mar 2012 - Oct 2014Principal Investigator - A Phase 3 Randomized, Double-Blind, Multicenter, Multi-Country, Placebo-Controlled, Combination Study that will Compare the Efficacy and Safety of Lesinurad Plus Allopurinol to Placebo or Lesinurad Plus Allopurinol in Approximately 750 Subjects with Gout who have had an Inadequate Hypouricemic Response to Standard of Care Allopurinol. 
Apr 2010 - Sep 2017Principal Investigator - A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in Subjects with Gout and Cardiovascular Comorbidities.
Jan 2007 - Apr 2008Sub-Investigator - A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects with Gout.
NEUROLOGICAL:
Migraine
May 2010 - Oct 2013Sub-Investigator - A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 4-Armed Parallel-Group Study to Evaluate the Efficacy of Zolmitriptan 0.5, 2.5 and 5 mg Nasal Spray in the Treatment of Acute Migraine Headache in Adolescents.
RESPIRATORY:
Asthma
Dec 2017 - Jun 2019Principal Investigator - A Randomized, Double-Blind, Parallel Group, Multi-Center 24-Week Study Comparing the Efficacy and Safety of Three Doses of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma
Jan 2015 - Apr 2016 Principal Investigator - A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
Nov 2014 - Jan 2016Principal Investigator - A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder Versus Advair Diskus® 100/50 Versus Placebo in Subjects with Asthma.
Mar 2012 - Jul 2015Principal Investigator - A Randomized, Double-Blind, Stratified, Parallel-Group, Multicenter Study that is Designed to Evaluate the Non-Inferiority of Fluticasone Propionate/Salmeterol Combination Versus Fluticasone Propionate on the Composite Endpoint of Serious Asthma Outcomes. 
Sep 2007 - Sep 2008Sub-Investigator - A 26-Week Treatment, Randomized, Multicenter, Double-Blind, Double-Dummy, Parallel-Group Study to Assess the Safety of Indacaterol (300 and 600 µg od) in Patients with Moderate to Severe Persistent Asthma Using Salmeterol (50 µg bid) as an Active Control.
COPD
Aug 2017 - Jun 2019Principal Investigator - A 6-week, randomized, double-blind, placebo and active-controlled, parallel group, dose ranging study to evaluate the efficacy and safety of 4 doses of CHF 5259 pMDI (glycopyrronium bromide) in subjects with Chronic Obstructive Pulmonary Disease (COPD)
Aug 2015 - Jun 2019 Principal Investigator - A Randomized, Double-Blind, Multi-Center, Parallel Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and Pt009 on COPD Exacerbations over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD. 
Aug 2015 - Jul 2006Principal Investigator - A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing Multi-Center Study to Assess the Efficacy and Safety of PT010,PT003, and PT009 Compared with Symbicort® Turbuhaler® as an Active Control in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.
Aug 2015 - Jul 2017Principal Investigator - Phase 3, 52-week, Randomized, Active-Controlled Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized TD-4208 in Subjects with Chronic Obstructive Pulmonary Disease. 
Apr 2015 - Aug 2017Principal Investigator - A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD. [DYNAGITO]
Nov 2014 - Aug 2016Principal Investigator - A phase III, 52 week, randomized, double-blind, 3-arm parallel group study, comparing the efficacy, safety and tolerability of the fixed dose triple combination FF/UMEC/VI with the fixed dose dual combinations of FF/VI and UMEC/VI, all administered once-daily in the morning via a dry powder inhaler in subjects with chronic obstructive pulmonary disease
Feb 2014 -    Mar 2015Principal Investigator - A Randomized, Double-Blind, Placebo- and Active-Controlled Parallel-Group Study to Assess the Efficacy of 12 Weeks of Once Daily Treatment of Two Doses of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (Delivered by the Respimat® Inhaler) in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) [OTEMPTO™].
Jun 2013 - Apr 2015Principal Investigator - A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared with Placebo.
Jun 2013 - Apr 2015Principal Investigator - A 28-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects with Moderate to Very Severe COPD, with Spiriva® Handihaler® as an Active Control.
Oct 2011 - Sep 2014Principal Investigator - A 52-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Treated with a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS). 
Jan 2013 - Jun 2014Principal Investigator - A 12-Week Treatment, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Study to Assess the Efficacy, Safety and Tolerability of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in COPD Patients with Moderate to Severe Airflow Limitation. 
Oct 2012 - Dec 2013Principal Investigator - A Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of 12 Weeks of Once Daily, Orally Inhaled, Co-Administration of Olodaterol 5 μg (Delivered by the Respimat® Inhaler) and Tiotropium 18 μg (Delivered by the HandiHaler®) Compared to Once Daily, Orally Inhaled, Co-Administration of Placebo (Delivered by the Respimat® Inhaler) and Tiotropium 18 μg (Delivered by the HandiHaler®) in Patients with Chronic Obstructive Pulmonary Disease (COPD).  
Oct 2012 - Dec 2013Sub-Investigator - A Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of 12 Weeks of Once Daily, Orally Inhaled, Co-Administration of Olodaterol 5 μg (Delivered by the Respimat® Inhaler) and Tiotropium 18 μg (Delivered by the HandiHaler®) Compared to Once Daily, Orally Inhaled, Co-Administration of Placebo (Delivered by the Respimat® Inhaler) and Tiotropium 18 μg (Delivered by the HandiHaler®) in Patients with Chronic Obstructive Pulmonary Disease (COPD). 
Jun 2012 - Jul 2013 Principal Investigator - A Phase 3, Randomized, Double-Blind, Extension Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients with Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).
Oct 2011 - Jun 2012Sub-Investigator - A 12-Week, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multicenter Trial to Assess the Efficacy and Safety of Tiotropium Bromide (18 μg) Delivered Via the Handihaler® in Patients with Newly Diagnosed and/or Maintenance Treatment-Naïve ChF3.
Oct 2011 - Nov 2012Principal-Investigator - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo for 24-Week Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).
Apr 2011 - Feb 2013Principal Investigator - A Clinical Outcomes Study to Compare the Effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25 mcg with Placebo on Survival in Subjects with Moderate Chronic Obstructive Pulmonary Disease (COPD) and a History of or at Increased Risk for Cardiovascular Disease.
Jul 2010 - Jul 2013Principal Investigator - A Randomized, Active-Controlled, Double-Dlind, Double-Dummy, Parallel-Group Design, Multicenter Trial to Compare the Efficacy and Safety of 2.5 μg and 5 μg Tiotropium Inhalation Solution Delivered by the Respimat® Inhaler with Tiotropium Inhalation Capsules 18 μg Delivered by the HandiHaler®. 
Sep 2009 - Jun 2011 Sub-Investigator - Phase 3, One-Year, Randomized, Open-Label Safety and Patient Acceptability Study of Combivent® Respimat® (Ipratropium Bromide and Albuterol Sulfate) (20/100 mcg) Inhalation Spray in Comparison to Combivent® Inhalation Aerosol (36/206 mcg) and the Free Combination of Atrovent® HFA (Ipratropium Bromide HFA) Inhalation Aerosol (34 mcg) and Albuterol HFA Inhalation Aerosol (180 mcg) in Adults with Chronic Obstructive Pulmonary Disease (COPD).
Jul 2009 - Jul 2012Principal Investigator - A Large Simple Safety Study of Arformoterol Tartrate Inhalation Solution in Subjects with Chronic Obstructive Pulmonary Disease.   
Jan 2009 - Dec 2009Principal Investigator - A 12-Week Treatment, Multicenter, Randomized, Parallel-Group, Double-Blind, Double-Dummy Study to Assess the Superiority of Indacaterol (159 µg od) Via a SDDPI in Patients with Moderate to Severe COPD, Using Salmeterol (50 µg bid) as an Active Comparator Delivered Via a DISKUS Inhaler.
Oct 2008 - Feb 2011Sub-Investigator - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally-Inhaled BI 1744 CL (5 μg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]) Delivered by the Respimat® Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD).
Jan 2008 - Sep 2008Sub-Investigator - A 12-Week Teatment, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Indacaterol (150 mg od) in Patients with Chronic Obstructive Pulmonary Disease.
Dec 2007 - Feb 2011Principal Investigator - A 26-Week Treatment, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients with Chronic Obstructive Pulmonary Disease (COPD).
May 2007 - Aug 2009Sub-Investigator - A Multinational, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Efficacy and Safety Comparison Over 24 Weeks of Three Doses (50 mg, 100 mg, 200 mg) of BEA 2180 to Tiotropium 5 g and Placebo Delivered by the Respimat® Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD).
Apr 2007 - Sep 2008Principal Investigator - A 26-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Adaptive, Seamless, Parallel-Group Study to Assess the Efficacy, Safety and Tolerability of Two Doses of a Long-Acting Beta-Agonist (Selected from 75, 150, 300, and 600 µg od) in Patients with Chronic Obstructive Pulmonary Disease Using Blinded Formoterol (12 µg bid) and Open Label Tiotropium (18 µg od) as Active Controls.
Apr 2007 - Jul 2008Sub-Investigator - A Randomized, Double-Blind, Double-Dummy, Parallel-Group Trial Comparing 12 Weeks Treatment with Tiotropium Inhalation Capsules 18 mcg Via the HandiHaler® Once Daily to Combivent® Inhalation Aerosol CFC MDI 2 Actuations qid in COPD Patients Currently Prescribed Combivent® Inhalation Aerosol CFC MDI.
Feb 2007 - Apr 2008Sub-Investigator - A Comparison of Ipratropium Bromide/Salbutamol Delivered by the Respimat® Inhaler to Combivent® Inhalation Aerosol and Ipratropium Bromide Delivered by the Respimat® Inhaler in a 12-Week, Double-Blind, Safety and Efficacy Study in Adults with Chronic Obstructive Pulmonary Disease.
Jan 2007 - Nov 2007Sub-Investigator - A Two-Week, Randomized, Modified-Blind, Double-Dummy, Parallel-Group Efficacy and Safety Study of Arformoterol Tartrate Inhalation Solution Twice-Daily, Tiotropium Once-Daily, and Arformoterol Tartrate Inhalation Solution Twice-Daily and Tiotropium Once-Daily (Dosed Sequentially) in Subjects with Chronic Obstructive Pulmonary Disease.
Nov 2005 - Nov 2007Sub-Investigator - A Multicenter, Double-Blind, Double-Dummy, Randomized, Active-Controlled, Parallel-Group Long-Term Safety Study of 15 μg and 25 μg Arformoterol Tartrate Inhalation Solution BID in the Treatment of Subjects with Chronic Obstructive Pulmonary Disease.
COPD - Data Only
Jan 2011 - Jun 2011Principal Investigator - COPD:  An Assessment of Treatment in Primary Care Practice Settings (CAPPS).