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A Randomised, Double-Blinded, Placebo-Controlled Phase II Trial to Determine the Safety and Efficacy of AM424 in the Prevention or Amelioration of Chemotherapy-Induced Neuropathy
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A multicentre, randomised, open-label, parallel group, comparison of Seretide Accuhaler™ (50/250 or 50/500 µg strength salmeterol/fluticasone propionate) bd with salmeterol 50 µg twice daily via one Accuhaler and either fluticasone 250 µg or 500 µg twice daily via another Accuhaler in adults with reversible airways disease.
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A multicentre, randomised, double-blind, parallel group, placebo-controlled study to investigate the long-term effects of salmeterol/fluticasone propionate (Seretide™/Viani™/Advair™) 50/500 µg bd, all delivered via the Diskus™/Accuhaler™ inhaler, on the survival of subjects with chronic obstructive pulmonary disease (COPD) over 3 years of treatment.
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Gaining Optimal Asthma Control (GOAL): A multi-centre, stratified, randomised, double-blind, parallel-group, step-up comparison of the level of asthma control achieved with salmeterol/fluticasone propionate combination Diskus™ (Accuhaler™) dry powder inhaler compared with fluticasone propionate Diskus™ (Accuhaler™) alone in adults and adolescents
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Efficacy and safety of Symbicort® (budesonide/formoterol) 1280/36 µg daily delivered dose compared to Pulmicort® (budesonide) 1600 µg metered dose plus Oxis® (formoterol) 36 µg delivered dose all delivered via Turbuhaler® in steroid-using asthmatic adolescents and adults. A double-blind, double-dummy, randomised, parallel-group, phase III, multicentre study
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Randomised, open, controlled trial to assess safety and acceptance of the 2001/2002-season intranasal influenza vaccine versus intramuscular influenza vaccines
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A randomised, double-blind, placebo-controlled, multicentre, Phase III study of Tarceva plus chemotherapy (cisplatin and gemcitabine) versus chemotherapy alone in patients with advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) who have not received prior chemotherapy.
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A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Oral Cilomilast (15 mg bd) When Given as Maintenance Treatment of 12 Months to Subjects with Chronic Obstructive Pulmonary Disease (COPD)
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Randomised Phase III Trial Comparing Targretin® Capsules/Cisplatin/Vinorelbine Versus Cisplatin/Vinorelbine in Chemotherapy-Naïve Patients with Advanced or Metastatic Non-Small Cell Lung Cancer.
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A 12-week multicentre, randomised, double-blind, placebo-controlled parallel-group study to compare the efficacy and tolerability of salmeterol/fluticasone propionate combination (SERETIDE™) 50/100 μg once daily in the morning with fluticasone propionate 100 μg once daily in the morning and placebo (short-acting β2-agonist as required only) once daily in the morning, all via the HFAMDI as initial maintenance therapy in mild asthmatic subjects.
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A 52-week multicentre, randomised, double-blind, double-dummy, placebo-controlled, parallel-group study to compare the efficacy and tolerability of salmeterol/fluticasone propionate combination (SERETIDE™) 50/100 μg once daily in the morning with fluticasone propionate 100 μg twice daily and placebo (short-acting β2-agonist as required only) twice daily, all via the ACCUHALER™ as initial maintenance therapy in mild asthmatic subjects.
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A phase IIb Comparative Study of the Safety and Efficacy of Three Oral Doses of ABT-492 for the Treatment of Subjects with Community Acquired Pneumonia
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Efficacy and safety of roflumilast 500 μg once daily compared with placebo as an add-on therapy to fluticasone propionate 12 μg twice daily over 24 weeks in patients with asthma
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A randomised, double-blind, double-dummy, 52-week, parallel-group study of a standard dosing regimen with salmeterol/fluticasone combination 50/125 μg bid (via the Accuhaler™ inhaler) versus a symptom-driven, variable-dosing regimen with formoterol/budesonide combination 4.5/160 μg (via a breath-actuated dry powder reservoir inhaler) in adult asthmatics.
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A randomised, double-blind, placebo-controlled study of subjects with previously untreated extensive end-stage small-cell lung cancer (SCLC) treated with platinum plus etoposide chemotherapy with or without darbepoetin alfa
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A randomised, double-blind, double-dummy, placebo-controlled, parallel-group study comparing ciclesonide (160 μg in the evening) and fluticasone/salmeterol (100 μg/50 μg b.i.d.) versus placebo in patients with mild bronchial asthma
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A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5 μg (two actuations of 2.5 μg) and 10 μg (two actuations of 5 μg)) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients with Chronic Obstructive Pulmonary Disease (COPD)
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Morning versus evening administration of 500 μg Roflumilast once daily for 6 weeks in patients with asthma
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A randomized, double-blind multicenter 2-stage phase III study of bevacizumab in combination with cisplatin and gemcitabine versus placebo, cisplatin and gemcitabine in patients with advanced or recurrent non-squamous non-small cell lung cancer, who have not received prior chemotherapy
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A phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with half dose (i.e. 75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 28-35 days, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.RE-NOVATE (Extended thromboembolism prevention after hip surgery)
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A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 8 ± 2 days, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery RE-MODEL (Thromboembolism prevention after knee surgery)
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Re:Efficacy and safety of Symbicort ® Turbuhaler ® 160/4.5 µg/inhalation, two inhalations twice daily plus as-needed compared with Seretide™ Diskus™ 50/500 µg/inhalation, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg/inhalation as-needed - a 6-month, randomised, double-blind, parallel-group, active controlled, multinational phase IIIB study in adult and adolescent patients with persistent asthma (AHEAD).
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A Phase 11 study to Investigate Mannitol Challenge as a tool to predict treatment response to Inhaled Corticosteroids in COPD
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults taking Opioid Therapy for Persistent Non-Cancer Pain
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A Randomized, Double-Blind, Placebo-Controlled, Multi-centre Phase 3 Study to Evaluate the Long-Term Safety of Alvimopan 0.5mg Twice Daily for 12 Months for the Treatment of Opioid-Induced Bowel Dysfunction in Adults taking Opioid Therapy for Persistent Non-Cancer Pain
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Randomised, double blind, multicentre, placebo controlled phase III study of the safety and tolerability following administration of live attenuated je vaccine (chimerivax™-je)
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International, Randomized, Open-Label, Phase 3, Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone As First Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer
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Effect of roflumilast on exacerbation rate in patients with COPD. A 52 weeks, double-blind study with 500 mcg roflumilast once daily versus placebo.
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A phase III Multicenter, randomised, parallel, placebo-controlled,double-blind study to investigate the safety and efficacy of treatment with Bronchitol (dry powder mannitol) in the symptomatic treatment of bronchiectasis.
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 6 Weeks in Adult and Adolescent Participants 12 years of Age and Older with Perennial Allergic Rhinitis (PAR)
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A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel plus or minus Sorafenib (BAY 43-9006) in chemonaive patients with Stage IIIB-IV Non-Small Cell Lung Cancer
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An observational survey to characterize the burden of illness associated with laxative use in subjects using opioids for the management of persistent non-cancer pain
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Open Label Extension Phase (Sub-study sites)- above protocol
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A 52-week randomised, double-blind, parallel group, placebo controlled, multicenter clinical trial, to assess the efficacy and safety of 200 µg of the anti-cholinergic LAS 34273 compared to placebo, both administered once-daily by inhalation, in the maintenance treatment of patients with moderate to severe stable chronic obstructive pulmonary disease
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A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (erlotinib) Following Complete Tumor Resection with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA Non‑small Cell Lung Carcinoma who have EGFR-positive Tumors (study)
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A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Long Term (one-year) Efficacy and Safety of Tiotropium Inhalation Solution 5µg (2 puffs of 2.5µg) Delivered by the Respimat® Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD).
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A phase III, multicenter, Placebo-controlled, double-blind, Randomized clinical trial to evaluateThe efficacy of bevacizumab inCombination with tarceva (erlotinib) Compared with tarceva alone for Treatment of advanced non-small cell Lung cancer (nsclc) after failure of Standard first-line chemotherapy
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A randomized, double-blind, placebo-controlled, phase IIIb trial comparing bevacizumab therapy with or without erlotinib after completion of chemotherapy with bevacizumab for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer
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Phase 11, A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50, 100 and 150 mg bid on annual FVC decline in patients with Idiopathic Pulmonary Fibrosis, with optional extension until the end of
the study.
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Efficacy and Safety of 2 mg/day of M100907 on Sleep Maintenance Insomnia: a 6-week, Multi-center, Randomized, Double-blind, Placebo-controlled Polysomnography Study - Nocturne 907 Study
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A randomized, Double –blind, parallel study of a once daily of EPI-12323 versus placebo in symptomatic moderate to severe asthmatics on low-dose inhaled corticosteroids
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A Randomised, Double-Blind, Active-controlled, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged release tablets in subjects with Moderate to Severe, Chronic Cancer Pain.
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A randomised, 4-week, placebo-controlled, double-blind, 6 arm parallel group, dose finding clinical trial, to assess the efficacy, safety and pharmacokinetics of three different doses of formoterol (6, 12 & 18 µg) combined with the inhaled anticholinergic aclidinium bromide 200µg, aclidinium bromide 200µg monotherapy, formoterol 12µg monotherapy and placebo all administered once daily by inhalation via ALMIRALL inhaler in patients with stable moderate to severe chronic obstructive pulmonary disease
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Multi-center, double-blind, randomized, placebo-controlled, active reference, parallel-group polysomnography study to assess the efficacy and safety of a 16-day oral administration of ACT-078573 in adult subjects with chronic primary insomnia - RESTORA 1
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A randomized, multicentre phase II study to explore whether biomarkers correlate with treatment outcome in chemo-naïve patients with advanced or recurrent non-squamous non-small-cell lung cancer, who receive treatment with bevacizumab (at a dose of either 7.5mg/kg or 15 mg/kg) in addition to Carboplatin-based chemotherapy (gemcitabine or Paclitaxel)
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A Randomized, double blind study to determine the effect of two dose schedules of R1507 or placebo, both in combination with erlotinib (Tarceva®), on progression-free survival in patients with advanced non-small cell lung cancer with disease progression after first or second line chemotherapy.
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A Double-Blind, Multi-Center, Placebo-Controlled Trial of SABER™‑Bupivacaine for Post-Operative Pain Control and Opioid Sparing/Opioid-Related Adverse Event Reduction Following Arthroscopic Shoulder Surgery
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Multicenter, randomized, double-blind, Phase III trial to investigate the efficacy and safety of oral BIBF 1120 plus standard pemetrexed therapy compared to placebo plus standard pemetrexed therapy in patients with stage IIIB/IV or recurrent non small cell lung cancer after failure of first line chemotherapy
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Randomised, 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)
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A randomised, open-label, phase III study of BIBW 2992 versus chemotherapy as first-line treatment for patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR activating mutation.
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A randomised, double-blind, active-controlled study to evaluate the impact of stepwise withdrawal of inhaled corticosteroid treatment in patients with severe to very severe chronic obstructive pulmonary disease (COPD) on optimised bronchodilator therapy.
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A multi-centre randomised, open-label phase II trial of Tarceva® in sequential combination with Gemcitabine compared to Gemcitabine Monotherapy as first line therapy in elderly or ECOG PS of 2 patients with advanced NSCLC
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A randomized. phase II, multi-center, double-blind, placebo-controlled study evaluating the safety and activity of MetMAb, a monovalent antagonist antibody to the receptor Met, administered to patients with advanced Non-Small Cell Lung Cancer, in combination with Tarceva®
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Randomized, placebo-controlled, double-blind, multi-center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis.
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A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
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A 48-week, double blind, randomized, multinational, multicentre, 2-arm parallel group, reference treatment controlled clinical trial of “fixed combination” beclomethasone dipropionate plus formoterol fumarate administered via pMDI (CHF 1535 Foster®) versus formoterol in patients with severe Chronic Obstructive Pulmonary Disease (COPD)
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A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once- Daily in Subjects with Asthma
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A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 μg, Open-Label) and Spiriva® Handihaler® (18 μg, Open-Label) as Active Controls
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(IPF Roll-Over Study)
A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)
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A Multi-Center, Prospective, Observational, Extension Trial Following DURECT Protocol C803-017 to Investigate the Long-term Safety of SABER™-Bupivacaine Following Arthroscopic Shoulder Surgery
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A Randomized, Double-blind, Parallel Group, 14-day, Multi-Center Study to Evaluate the Safety of PT003, PT005, PT001 and Foradil® Aerolizer® (12 µg, Open‑Label) as Evaluated by Holter Monitoring, in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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A Clinical Outcomes Study to compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease.
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A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects with Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX1)
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Effect of roflumilast on exacerbation rate in patients with COPD treated with fixed combinations of LABA and ICS. A 52-week, randomised double-blind trial with roflumilast 500 μg versus placebo The REACT-trial
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A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 µg / 5 and 5 µg / 5 µg) (delivered by the Respimat® Inhaler) compared with the individual components (2.5 µg and 5 µg tiotropium, 5 µg olodaterol) (delivered by the Respimat® Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD) - [TOnadoTM 1]
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A Phase III, 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-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
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A randomised, double-blind, 5 treatment arms, 4-period, incomplete cross-over study to determine the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (FDC) (2.5 / 5 µg; and 5 / 5 µg) (delivered by the Respimat® Inhaler) compared with tiotropium (5 µg), olodaterol (5 µg ) and placebo (delivered by the Respimat® Inhaler) on lung hyperinflation and exercise endurance time during constant work rate cycle ergometry in patients with Chronic Obstructive Pulmonary Disease (COPD) MORACTO™ 1
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A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution / Aztreonam 75mg Powder and Solvent for Nebuliser Solution in Subjects with non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)
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Phase 2, Randomized Dose-ranging Study to Evaluate the Efficacy of Tralokinumab in Adults with Idiopathic Pulmonary Fibrosis
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A randomized, double-blind placebo-controlled study to compare the efficacy of indacaterol with that of placebo in patients with COPD who have not previously received maintenance COPD medication, using blinded tiotropium as active control
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A Multinational, Randomized, Open-Label Phase III Study of Custirsen (TV-1011/OGX-011) In Combination With Docetaxel Versus Docetaxel As A Second-Line Treatment In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer
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Randomized, double-blind, placebo-controlled, multicEnter Study comparing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. (RESPIRE 1)
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A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo and Spiriva® Handihaler® (Tiotropium Bromide 18 μg, Open-Label) as an Active Control
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A multicenter, randomized, blinded, active-controlled, parallel-group study to compare the efficacy, tolerability and safety of NVA237 compared to tiotropium added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary disease (Glisten)
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A phase lll, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lebrikizumab in patients with uncontrolled asthma who are on inhaled corticosteroids and a second controller medication (LAVOLTA11)
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A randomised, 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) OTEMTO™2
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An exploratory, 12 week, randomised, partially double-blinded, placebo-controlled, parallel group trial to explore the effects of once daily bronchodilator treatment, supervised exercise training and behavioural modification on exercise capacity and physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD) [PHYSACTOTM]
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A 12-week Phase II Study to Evaluate the Efficacy and Safety of AQX-1125 Following Exacerbations in Patients with Chronic Obstructive Pulmonary Disease (COPD) by Targeting the SHIP1 Pathway
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4)
A Phase III, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel versus Docetaxel Alone as Second-Line Therapy in Patients with Stage IIIb/IV Non-Squamous Non‑Small-Cell Lung Cancer
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