NARES2 - Publications

NARES2 clinical trials as of 12/06

Psychosocial Research:
(Clicking on the title provides a PDF copy of the full text for the paper.)

Reilly, T. and Grace Woo. “Predictors of High-Risk Sexual Behavior Among People Living with HIV/AIDS.” AIDS and Behavior Vol. 5: No. 3 (2001).


Reilly, T. and Grace Woo. "Access to Services and Maintenance of Safer Sex Practices Among People Living with HIV/AIDS." Social Work in Health Care Vol. 36: No. 2 (2003).


Reilly, T. and Grace Woo. “Social Support and Maintenance of Safer Sex Practices Among People Living with HIV/AIDS.” Health and Social Work Vol. 29: No. 2 (2004).


Reilly, T. DPA and Smith L., Phd. "Reasons for Unsafe Sex Among a Community Sample of People with HIV / AIDS" Social Work in Health Vol.41(2) 2005

 

Medical Research:

Albendazole (Eskazole) for Compassionate Use in Microsporidiosis (IND 45062). Principal Investigator, SmithKline Beecham.

Azithromycin.  Oral/Intravenous Azithromycin Treatment of Cryptosporidiosis in Patients Whose Disease has not been Controlled by Conventional Therapy (066- 167S). Principal Investigator, Premier Research.

Saquinavir.  HIV Proteinase Inhibitor Saquinavir Ro 31-8959 (SV14604). Investigator,   F. Hoffmann LaRoche Limited.

Saquinavir Ro 31-8959 A Continuation Protocol with Open Label Saquinavir for HIV-1  Infected Patients Who Have Completed a Clinical Trial with Saquinavir Treatment (SV 14788). Co-investigator, F. Hoffmann LaRoche Limited. Lamivudine.  3TC (Lamivudine) Open Label Program (NUCA 3004). Investigator, Glaxo, Inc.

Ambisome.  Compassionate Use of Ambisome for Treatment of Invasive Fungal Infections in Patients Intolerant to, or with, Disease Unresponsive to Standard Antifungal Therapy (95-0-010).  Investigator, Fujisawa USA. Principal Investigator.

Mycobutin (Rifabutin).  An Open-Label Randomized Pharmacological/ Pharmacodynamic study of mycobutin (Rifabutin) monotherapy, and in combination with myambutal (Ethambutal), for prophylactic use in prevention of Mycobacterium-Avium Complex (MAC) bacteria in AIDS patients with CD4 count < 100mm³.  Principal Investigator, Pharmacia.

Indinavir (Crixivan).  A Noncomparative, Multisite, Open-Label, 48-Week Study To Monitor the Safety and Tolerability of MK-0639 (Indinavir Sulfate) 800mg q8h Administered as Monotherapy or in Combination with Reverse Transcriptase Inhibitor Therapy for the Treatment of HIV-1 Infection in Advanced AIDS Patients (Patients with CD4 Counts # 50cells/mm3 (99-00). Investigator, Merck and Co., Inc.

Vistide (Cidofovir).  IV Treatment IND Protocol for Relapsing Cytomegalovirus Retinitis in Patients with AIDS (GS 95120). Principal Investigator, Gilead Sciences.

Synercid.  Emergency Use Open Study of Synercid (Quinupristin/Delfopristin, RP 59500) for Infections Due to Resistant Bacteria Treatment Failure or in Treatment Intolerant Patients.  Protocol JRV 398.  Investigator, Rhone- Poulenc Rorer.

Nitazoxanide.  Open-Label Compassionate Use of Nitazoxanide for the treatment of  Cryptosporidiosis in AIDS patients.  Protocol UMD-95-009.  Principal Investigator, Unimed Pharmaceuticals.

Viracept.  Viracept Expanded Access Program (Ind#  48.124).  Principle Investigator, Auguron.

Nevirapine (Viramune).  An Open Label Non-Randomized Trial to Evaluate the
Tolerability and safety of Viramune (nevirapine) in Adult and Pediatric Patients with Progressive, Symptomatic HIV Disease.  Protocol 1100.859. Principal Investigator, Roxanne.

Viracept.  An Open-Label Study to Evaluate Viracept Treatment of HIV-Infected Children Who Could Benefit from a Protease Inhibitor Based on Clinical or Immunologic Status (AG1343-546).  Investigator, Aguoron. 

Saquinavir.  A Randomized Phase IIIB Comparative Study to Evaluate Saquinavir Soft Gel Capsules (SGC) TID Regimen in Combination with two NRTI’s Versus Saquinavir Soft Gel Capsules (SGC) BID Regimen in Combination with two NRTI’s Versus Saquinavir Soft Gel Capsules (SGC) BID plus Nelfinavir BID plus an NRTI in HIV-1 Infected Patients (NR5520B/M51018).  Investigator, F. Hoffmann-La Roche LTD.

A 1592U89 Open Label Protocol of Adult Patients with HIV-1 Infection (CNAA/3008). Principal Investigator, Glaxo Wellcome Research & Development.A 1592U89 Open Label Protocol for Pediatric Patients with HIV Infection (CNAA/3007).  Investigator, Glaxo Wellcome Research & Development.  Thalidomide.  Treatment of Aphthous Ulcers in a Patient with Behcet’s Syndrome, having Failed Steroid and Immunosuppressive Therapy (IND# 53,970).  Investigator.

Preveon Expanded Access Program for the Treatment of Patients with AIDS Who Have Failed Other Antiretroviral Therapy and have Limited Treatment Options (GS-52-427). Investigator, Gilead Sciences.

Thalidomide.  Treatment of Aphthous Ulcers in a Patient with Behcet’s Syndrome Having Failed Steroid and Immunosuppressive Therapy (IND# 54,463). Principal Investigator. 

Sustiva (efavirenz).  Expanded Access Program DMP266-903 (IND# 49,465).  Principal Investigator, DuPont Merck. 

An Open-Label Multicenter Study to Assess the Safety and Antiviral Activity of a Twice-Daily Dosing Regimen of Viracept Combined with Two Reverse Transcriptase Inhibitors in HIV-Infected, Treatment Naive Patients (AG13543-1022), Investigator, Auguron

Compassionate Use of Thalidomide in Hypocomplementemic Urticarial VasculitisSyndrome (IND 55,590), Investigator.

A Multicenter Open Label Randomized 24-Week Study to Compare the Safety and activity of Indinavir Sulfate 800mg Q8H Versus 1200mg Q12H in HIV-1 Infected Individuals Having Plasma Viral RNA Less Than 400 copies/ml on Concomitant herapy with Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTI) 076-00.  Investigator, Merck & Company.  

The Thalidomide Compassionate Use Program.  Compassionate Use of Thalidomide in Adults with HIV-Associated Wasting (W-002), Investigator, Celgene Corp (1998).

Amprenavir (141W94).  Open label protocol for patients with HIV-1 infection who ave experienced treatment failure or are intolerant to protease therapy, PR030010), Principal Investigator, Glaxo Wellcome, Dec. 1998. 

A Phase III trial to determine efficacy of bivalent AIDSVAX™ B/B vaccine in adults t risk for sexually transmitted HIV-1 infection in North America (VAX004), Principal nvestigator, Vaxgen Inc., March, 1999. 

Evaluation of the safety and antiviral activity of stavudine extended release ormulation as compared to stavudine immediate release formulation, each as part of potent antiretroviral combination therapy. (AI455-096), Principal Investigator, Bristol-Myers Squibb, Oct 1999.

DE 009.  A multicenter randomized placebo controlled phase II study of the Human Anti-TNF Antibody D2E7 administered as subcutaneous injections in rheumatoid arthritis patients treated with methotrexate. (LU 200134).  Knoll Pharmaceutical Corp. Investigator.  Dec. 1999.

O99009 Transdermal oxybutynin in patients with urge urinary incontinence: A 12 week multicenter, randomized, double-blind, placebo-controlled study with a 12-week open-label, dose-titration, safety extension.  Watson Laboratories.  Investigator. Jan. 2000.

Protocol M99-046. ABT-378/r (ABT-378/ritonavir) Early Access Program.  Abbott Laboratories. Principal Investigator. Jan 2000.

Protocol ESS 40001 A Phase IV, open-label, randomized study to compare the efficacy and safety of Epivir/Ziagen/Zerit versus Epivir/Ziagen/Sustiva versus Epivir/Ziagen/Agenerase/Norvir for 96 weeks in the treatment of HIV-1 infected subjects who are Antiretroviral therapy naive.  Glaxo Wellcome. Principal          nvestigator. Aug 2000.

Protocol ESS 40009 Ziagen Optimal Regimen and Resistance Observational tudy.  A Phase IV, Open-label study to assess the safety and tolerability of abacavir (Ziagen), in HIV-1 infected individuals and to investigate the effect of baseline genotype with virtual phenotype on the response to abacavir (Ziagen) in therapy experienced subjects in the clinical setting.GlaxoWellcome Research and Development. Investigator. Aug 2000.

AII455-110. A Study to Compare Long-Term Safety and Tolerability of Stavudine (D4T) Extended Release (ER) versus Conventional (Immediate Release, IR) Formulations, Each in Combination with Lamivudine (3TC) and Efavirenz (EFV) in Subjects who have Completed BMS Studies AI455-096 and AI455-099. Britstol-Myers Squibb. Principal Investigator. Jan 2001.

ESS40013. A Phase IV Muliticenter Study of the Efficacy and Safety Of 48- Week Induction Treatment with Trizivir + Efavirenz Followed by 48-Week Randomized, Open-Label Maintenance Treatment with Trizivir ± Efavirenz in HIV-1 Infected ART Naïve Subjects. GlaxoSmithKline. Investigator. March 2001.

CLAF237A 2203.  A 12-week, multicenter, double-blind, randomized, parallel-group, dose-ranging study to assess the efficacy, safety and tolerability of LAF237 25mg bid, 25, 50 or 100mg OD compared to placebo in patients with type 2 diabetes.  Novartis. Investigator.  2001

N49-01-02-193.  Clinical protocol for the assessment of the efficacy of treatment by Celecoxib 200mg QD and 400mg Qd on the symptoms of ankylosing spondylitis compared to naproxen and placebo. Pharmacia.  Investigator. 2001

MEM-MD-06.  Evaluation of the safety and efficacy of memantine in the treatment of chronic pain in patients with painful diabetic neuropathy.  Forest Laboratories. Investigator. 2001.

HMR3647A/3014.  Randomized, open-label, multicenter trial of the safety and effectiveness of Oral telithromycin (Ketek) and amoxicillin/clavulanic acid (Augmentin) in outpatients with respiratory tract infections in usual care settings. Aventis Pharmaceuticals, Inc. Investigator. 2001.

Astra Zeneca 233.  Efficacy and safety study of the oral direct thrombin inhibitor H 376/95 compared with dose-adjusted warfarin (Coumadin) in the prevention of stroke and systemic embolic events in patients with atrial fibrillation (SPORTIF V).  Astra Zeneca. Investigator. 2001.

N91-00-02-079.  Clinical protocol for a randomized, double-blind, placebo- controlled, parallel group comparison of the analgesic activity of valdecoxib (SC- 65872) 20mg bid versus diclofenac 75mg bid in patients with chronic cancer pain. Pharmacia/Pfizer. Investigator. 2001.

NARES001.  Predictors of high-risk sexual behavior among people living with HIV/AIDS in Las Vegas, Nevada. Nevada AIDS Research and Education Society.  Principal Investigator.  2001.

CNA30021.  A phase III, 48 week, randomized, double-blind, multicenter study  to evaluate the safety and efficacy of abacavir (ABC) 600mg once-daily(QD) vs abacavir 300mg BID in combination with lamivudine (3TC) (300mg QD) and efavirenz (EFV) (600mg QD) in antiretroviral therapy Naive HIV-1 infected subjects. GlaxoSmithKline. Principal Investigator. 2001.
                       
HIV-TE - Evaluation Project 101.  An Evaluation of the Use of the HIV-Therapy Edge (HIV-TE) Service in the Management of HIV-Positive Patients Currently Failing Antiretroviral Drug Therapy.  Intelligent Therapeutic Solutions, Inc.   Investigator. 2001.

O00011.  A multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing Oxybutynin Transdermal Systems versus Tolterodine Long Acting Capsules in Patients with Overactive Bladder.  Investigator. Watson Laboratories, Inc. 2001.

Nateglinide/CDJN608B (NAVIGATOR). A multinational, randomized, double- blind, placebo-controlled, forced-titration, 2 X 2 factorial design study of the efficacy and safety of long term administration of nateglinide and valsartan in the prevention of diabetes and cardiovascular outcomes in subjects with impaired glucose tolerance.  Novartis. Investigator. 2001.

M016455P/3003.  A multicenter, open label, randomized, parallel group study toassess the long term safety, performance, and efficacy of fexofenadine compared to montelukast in subjects with asthma.  Aventis.  Investigator. April 2002.

AI424-045.  A randomized, open label study of the antiviral efficacy and safety of atazanavir, in combination with ritonavir or saquinavir, and the combination of lopinavir each with tenofovir and a nucleoside in subjects who have experienced virologic failure.  Bristol-Myers Squibb.  Principal Investigator. April 2002.

CFOR258D2307.  A randomized, multicenter, placebo controlled, parallel group study, of four month duration per patient, to evaluate the safety and efficacy of treatment with 24mcg bid and 12mcg bid formoterol double blind and 12mcg bid formoterol with additional on demand formoterol doses open label in adolescent and adult patients with persistent stable asthma. Novartis. Investigator. April 2002.

BI1182.52.  Double-blind, randomized, dose optimization trial of three doses of tipranavir boosted with low dose ritonavir (TPV/RTV) in multiple antiretroviral drug-experienced subjects.  Boehringer Ingelheim Pharmaceuticals, Inc.  Principal Investigator. May 2002.

MEM-MD-06.  Evaluation of the long term safety and efficacy of memantine in the treatment of chronic pain in patients with painful diabetic neuropathy.  Forest Laboratories. Investigator. June 2002. 

ZOL446H2310 (zoledronic acid).  Multinational, multicenter, double-blind, randomized, placebo controlled, parallel group study assessing the efficacy of intravenous zoledronic acid in preventing subsequent osteoporotic fractures after a hip fracture.  Novartis. Investigator. June 2002.

AI424900.  Atazanavir (BMS-232632) for HIV infected individuals: An early access program.  Bristol-Myers Squibb.  Principal Investigator. July 2002.

BI1182.17.  A long term open label rollover trial assessing the safety and tolerability of combination tipranavir and ritonavir use in HIV-1 infected subjects. Boehringer Ingelheim Pharmaceuticals, Inc. Principal Investigator. August 2002.

MV16812.  Multicenter, open-label, early access program of fuzeon (enfuvirtide) T-20/Ro29-9800, HIV-1 Fusion Inhibitor) in combination with free choice antiretroviral regimen to assess serious adverse events, serious AIDS defining events, and tolerability in patients with advanced HIV-infection. F. Hoffmann- LaRoche LTD, Trimeris Inc., Investigator.

BI1182.12. Randomized, open-label, comparative safety and efficacy study of  tipranavir boosted with low-dose ritonavir (TPV/RTV) versus genotypically-defined protease inhibitor/ritonavir (PI/RTV) in multiple antiretroviral drug-experienced patients (RESIST-1: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients with Tipranavir). Boehringer Ingelheim Pharmaceuticals, Inc. Investigator. Jan 2003.

BI1182.51. An open label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced patients. Boehringer Ingelheim Pharmaceuticals, Inc. Investigator. January 2003. 

CCIB002K2302. A randomized, double-blind, multicenter,positive controlled, parallel group study to evaluate the safety and efficacy of LotrelR (amlodipine/benazepril) compared to ZestoreticR (lisinopril/hydrochlorothiazide) in hypertensive patients. Novartis. Investigator. January 2003.

BI1182.58. An open label safety study to evaluate the safety of tipranavir plus ritonavir when used in combinations with other agents for the treatment of patients with HIV infection who have failed and/or are intolerant to combination antiretroviral therapy and have limited treatment options.  Boehringer Ingelheim Pharmaceuticals, Inc. Investigator. April 2003.

CHTF919A2306. A randomized, double-blind, placebo-controlled, parallel group, multicenter study to assess the efficacy and safety of repeated treatment with tegaserod 6mg bid and placebo in female patients with irritable bowel syndrome with constipation (IBS-C). Novartis. Investigator. July 2003.

CVAH631C2301. A 54-week open-label extension to a randomized, double- blind, multicenter, placebo-controlled, parallel group study to evaluate the efficacy and safety of valsartan (320mg) and hydrochlorothiazide (12.5mg and 25mg) combined and alone, valsartan 160mg and valsartan 160mg/hydrochorothiazide 12.5mg in hypertensive patients. Novartis Pharmaceuticals. Investigator. 2003. 

A3841012. Clinical utility of amlodipine/atorvastatin to improve concomitant cardiovascular risk factors of hypertension and dyslipidemia (Gemini). Pfizer.  Investigator. 2003.

BY217/M2-023. A randomized, controlled study of roflumilast (250mcg and 500mcg) versus placebo in patients with asthma.  A 24-week, multinational, double-blind, parallel group clinical study. Altana. Investigator. 2003

066-00. A randomized, double-blind, active-comparator-controlled, parallel-group study to evaluate the safety of etoricoxib on patients with osteoarthritis or rheumatoid arthritis.  Merck. Investigator. 2003.

MK-038. A multicenter, randomized, double-blind, placebo-controlled, “factorial” design study to evaluate the lipid-altering efficacy and safety of ezetimibe/simvastatin combination tablet in patients with primary hypercholesterolemia. Merck. Investigator. 2003.

C02-009. A phase III, randomized, multicenter, allopurinol and placebo- controlled study assessing the safety and efficacy of oral febuxostat in subjects with gout. Tap Pharmaceuticals. Investigator. 2003.

D5896C00005. A two-stage randomized, open-label, parallel group, phase III, multicenter, 7-month study to assess the efficacy and safety of SymbicortR pMDI administered either as fixed or as an adjustable regimen versus a fixed regimen of AdvairR in subjects 12 years and older with asthma. AstraZeneca. Investigator.
January 2004.

4522US/0011. A randomized, double-blind, placebo-controlled, multicenter, phase III study of Rosuvastatin (Crestor) 20 mg in the primary prevention of cardiovascular events among subjects with low levels of LDL- Cholesterol and elevated levels of C-reactive protein. AstraZeneca. Investigator. June 2004

NN210005. A phase I, multicenter, randomized, parallel, double-blinded dose ranging, placebo-controlled study to compare antiviral effect, safety, tolerability and pharmacokinetics of four oral dosage regimens of GW695634G monotherapy versus placebo over 7 days in NNRTI-experienced HIV-1 infected adults. GlaxoSmithKline. Principal Investigator. July 2004.

CCOX189A2369. A 52-week, international, multicenter, randomized, double-blind, double-dummy, parallel-group clinical trial to compare retention on treatment, safety, tolerability and efficacy of lumiracoxib 100mg od, lumiracoxib 100mg bid and celecoxib 200mg od in patients with primary osteoarthritis of hip, knee, hand or spine. Novartis Pharmaceuticals. Investigator. July 2004.

D5896C00001. A randomized, double-blind, active-controlled, parallel-group, single-dummy, multicenter, 12 week study to assess the efficacy and safety of Symbicort pMDI 160/4.5 ug x 2 actuations once-daily (QD) compared to symbicort pMDI 80/4.5 ug x 2 actuations QD, Symbicort pMDI 80/4.5 ug x 2 actuations twice-daily (BID) and to budesonide pMDI 160 ug x 2 actuations QD in asthmatic subjects 12 years of age and older.  AstraZeneca Pharmaceuticals LP. Investigator. July 2004.

L8890. Prospective, observational registry and patient survey of the management of men with symptomatic benign prostatic hyperplasia (BPH):  BPH registry and patient survey. Sanofi. Investigator. September 2004.

COL102060. An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of a Fixed-Dose Combination of Abacavir 600 mg/Lamivudine 300 mg Once-Daily in Combination with Atazanavir 300 mg + Ritonavir 100 mg Once- Daily in Antiretroviral-Naїve HIV-1 Infected Subjects Over 48 Weeks.  GlaxoSmithKline.  Investigator. October 2004.

Protocol ML18018:  A 12-Week, Prospective, Open-label, Multicenter, Cohort Study to Assess HIV-Patient QUAlity of LIfe and Tolerability After Administration of Enfuvirtide-Containing HAART (QUALITE). Roche. Investigator. December 2004.

BI1182.70.  An Open Label, Non-randomized Treatment Protocol of Tipranavir Co-administered with Low-dose Ritonavir (TPV/r) in Protease Inhibitor- experienced Patients with HIV-1 Infection (the Tipranavir Expanded Access Program). Boehringer Ingelheim. Principal Investigator.  December 2004.

HMR3647A/4019. A randomized, double-blind, parallel-group, multicenter study to compare clinical health outcomes of telithromycin versus azithromycin in outpatients with community-acquired lower respiratory tract infections. Aventis Principal Investigator. February 2005.

CCR102881. A Phase IIb, 96 week, randomized, partially double-blinded, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of GW873140 in combination with COMBIVIR (lamivudine and zidovudine) upon selected immunological and virological markers of HIV-1 infection in antiretroviral therapy naive adults. GlaxoSmithKline. Principal Investigator.  March 2005.

CCR104627. A screening protocol to determine eligibility for one of three Phase III treatment studies evaluating the efficacy and safety of GW873140 in R5-tropic and R5/X4-tropic HIV-1 infected, treatment-experienced subjects with drug- resistant virus or an observational study in X4-tropic or non-phenotypeable HIV-1 infected, treatment-experienced subjects with drug-resistant virus. GlaxoSmithKline. Principal Investigator. July 2005.

U10-04-02-007. A randomized, double-blind, placebo-controlled, multicenter, pilot study to evaluate the safety and analgesic activity of M40403 co-administered with an opioid agent in a cancer pain model. Metaphore Pharmaceuticals. Investigator. July 2005

CVAH631BUS04/A. A 28 week, multicenter, randomized, active controlled, parallel group study to evaluate the effects of Diovan HCT (160/12.5 mg) in comparison with hydrochlorothiazide (25 mg) monotherapy, for the treatment of patients with hypertension, uncontrolled by hydrochlorothiazide (12.5 mg) monotherapy. Novartis. Investigator. August 2005.

CSPP100A2328. A randomized, double-blind, placebo-controlled, parallel-group, multicenter study comparing an eight week treatment of aliskiren 75 mg, 150 mg and 300 mg to placebo in patients with essential hypertension. Novartis. Investigator. August 2005.

HPR20001. A phase IIb, randomized, multicenter, parallel group study to evaluate the short-term safety, pharmacokinetics and antiviral activity of four blinded dosing regimens of GW640385/ritonavir therapy compared to open-label current protease inhibitor therapy in HIV-1 infected, protease inhibitor experienced adults for 2 weeks with long-term evaluation (>48 weeks) of safety, pharmacokinetic and antiviral activity of selected GW640385/ritonavir dosing regimen(s) vs. a ritonavir-boosted, protease inhibitor containing regimen. GlaxoSmithKline. Principal Investigator. October 2005.

TMC114-C211. A randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114/ritonavir versus lopinavir/ritonavir in treatment-naïve HIV-1 infected subjects. ARTEMIS TRIAL.Tibotec Pharmaceuticals Ltd. Investigator. November 2005.

TMC114-C226. Early access of TMC114 in combination with low-dose ritonavir (RTV) and other antiretrovirals (ARVs) in highly treatment experienced HIV-1 infected subjects with limited to no treatment options. Tibotec Pharmaceuticals Ltd. Investigator. November 2005.

M05-750. A multicenter, randomized, double-blind, prospective study comparing the safety and efficacy of fenofibric acid and atorvastatin calcium combination therapy to fenofibric acid and atorvastatin calcium monotherapy in subjects with mixed dyslipidemia. Abbott Laboratories. Principal Investigator. December 2005.

M05-758. A long-term, open-label, safety extension study of the combination of fenofibric acid and statin therapy for subjects with mixed dyslipidemia. Abbott Laboratories. Principal Investigator. December 2005.

D5899C00001. A 12 month double-blind, double-dummy, randomized parallel group, multicenter efficacy and safety study of SYMBICORT® pMDI 2 x 160/4.5 mcg bid and 2 x 80/4.5 mcg bid compared to Formoterol TBH 2 x 4.5 mcg bid and placebo in patients with COPD. AstraZeneca. Investigator. March 2006.

 

 

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