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| Study Number | Completed Clinical Trial Report Summaries |
| BN-00S-0011 | Effects of Symbicort Single Inhaler Therapy on top of a regular daily dose on Bronchial Hyperresponsiveness, asthma control and safety in mild to moderate asthmatics in general practice, compared to usual care therapy. |
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BN-00S-0022 | A randomized double blind comparison between single doses of Symbicort Turbuhaler (budesonide/formoterol combination), formoterol, salbutamol and placebo in repeated AMP-challenges in patients with mild - to moderate asthma. Investigating the supplementary value of the budesonide component within Symbicort when tested in a model of slow onset acute asthma. |
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D5890C00002 | Efficacy and safety of Symbicort® Turbuhaler® 160/4.5 mcg/inhalation, two inhalations twice daily plus as-needed compared with Seretide™ Diskus™ 50/500 mcg/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. |
D5890C00007 | Onset of relief of dyspnoea after methacholine provocation with single doses of one inhalation of Symbicort® Turbuhaler® 160/4.5 mcg/inhalation, two inhalations of Ventoline™ via pMDI 100mcg/actuation, or placebo in adults with asthma - a randomised, double-blind, cross-over, phase IIIB study. |
D5890C00009 | An open, phase III, multicentre, 52-week study, evaluating the safety and efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 μg twice daily) in Japanese patients with asthma |
D5890L00001 | Symbicort and Health Economics in a Real Life Evaluation – SHARE – A randomised, open-label, parallel-group, multicentre study to assess the asthma related health care costs, in ordinary clinical practice during 12 months |
D5892L00002 | A randomised, double blind, double dummy, multicentre phase III study comparing the efficacy of budesonide/formoterol (Symbicort® forte Turbuhaler®) and oral prednisolone + formoterol (Oxis® Turbuhaler) during
two weeks, in COPD patients with an acute exacerbation, followed by twelve weeks open follow up period with budesonide/formoterol (Symbicort forte Turbuhaler) - SPACE |
D5890L00005 | A comparison of Symbicort Single inhaler Therapy (Symbicort Turbuhaler 200/6 μg, 1 inhalation b.i.d. plus as needed) and conventional best practice for the treatment of persistent asthma in adolescents and adults – a 26-week, randomised, open, parallel group multicentre study. |
D5890L00008 | A comparison of the efficacy of Symbicort® SMARTª (Symbicort Turbuhaler® 160/4.5 μg 1 inhalation bi.d. plus as-needed) and conventional best standard treatment for the treatment of persistent asthma in adolescents and adults. A randomized, open, parallel-group, multicentre, 26 weeks study. |
D5890L00009 | A comparison of Symbicort Single inhaler Therapy (Symbicort Turbohaler 160/4.5 μg, 1 inhalation b.i.d. plus as needed) and conventional best practice for the treatment of persistent asthma in adolescents and adults - a 26-week, randomised, open-label, parallel-group, multi-centre study (SALTO) |
| D5890L00012 | Real life effectiveness in asthma of Symbicort® Single Inhaler Therapy (RELEASE). |
| D5890L00017 | A comparison of budesonide/formoterol Turbuhaler®160/4.5 μg 2 inhalations BID plus as needed (Symbicort Maintenance and Reliever Therapy) to budesonide Turbuhaler® 320 μg 2 inhalations BID plus terbutaline Turbuhaler® 0.4 mg as needed for the prevention of asthma relapse following emergency department discharge due to an asthma exacerbation. An 8 week, randomized, double blind, parallel group, active controlled, multicentre phase IIIB efficacy study in adult asthmatic patients. |
| D5890L00031 | NIS for patients using Symbicort Turbuhaler for maintenance and reliever therapy in a single inhaler. |
D5892C00013 | A randomized, double-blind, double-dummy, two-way cross-over study evaluating systemic bioavailability and airway clearance of Symbicort® Turbuhaler® 320/9 μg/inhalation versus Seretide™ Diskus™ 50/500 μg/inhalation after single inhalations in patients with Chronic Obstructive Pulmonary Disease (COPD) and healthy volunteers |
D5892C00013 | A 6-month phase IIIA, multi-centre, randomised, double-blind, doubledummy, parallel-group study of the efficacy and safety of budesonide/formoterol (Symbicort®) Turbuhaler® 160/4.5μg/inhalation, two inhalations twice daily plus terbutaline (Bricasol®) pMDI (0.25mg/dose) as
needed compared with budesonide (Pulmicort®) Turbuhaler® (200μg/dose), two inhalations twice daily plus terbutaline (Bricasol®) pMDI (0.25mg/dose) as needed, in Chinese subjects with chronic obstructive pulmonary disease (COPD) |
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 mcg x 2 actuations once-daily (qd) compared to SYMBICORT pMDI 80/4.5 mcg x 2 actuations qd, SYMBICORT pMDI 80/4.5 mcg x 2 actuations twice-daily (bid) and to budesonide pMDI 160 mcg x 2 actuations qd in asthmatic subjects 12 years of age and older |
D5896C00005 | A two-stage randomized, open-label, parallel group, phase III, multicenter, 7 month study to assess the efficacy and safety of SYMBICORT® pMDI administered either as fixed or as an adjustable regimen versus a fixed regimen of Advair™ in subjects 12 years of age and older with asthma |
D5896C00023 | A Two-Week, Randomized, Double-Blind Study Assessing the Onset of Effect Questionnaire (OEQ) Administered Daily Versus Weekly in Adult Subjects (≥18 Years of Age) with Mild to Moderate Asthma, Receiving SYMBICORT® pMDI 80/4.5 μg x 2 Actuations Twice Daily or Budesonide
HFA pMDI 80 μg x 2 Actuations Twice Daily |
D5896C00025 | A Two-Week, Randomized, Double-Blind Study Assessing the Onset of Effect Questionnaire (OEQ) Administered Pre-dose Versus Post-dose in Adult Subjects (≥18 Years of Age) with Mild to Moderate Asthma, Receiving SYMBICORT® pMDI 80/4.5 μg x 2 Actuations Twice Daily or Budesonide HFA pMDI 80 μg x 2 Actuations Twice Daily |
D5899C00002(SHINE) | A 6-Month Double-blind, Double-dummy, Randomized, Parallel group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 mcg & 80/4.5 mcg bid Compared to Formoterol TBH, Budesonide pMDI (& the combination) & placebo in COPD Patients. |
D5899C00001 | A 12-Month Double-blind, Double-dummy, Randomized, Parallel group, Multicenter Efficacy & 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 |
D5899C0748 | A randomised, placebo-controlled, double-blind, double-dummy, crossover study to assess the onset of action of two inhalations of Symbicort 160/4.5 mcg, compared with two inhalations of Seretide 25/250 mcg, two inhalations of Ventoline 100 mcg, and placebo, delivered by pressurised metered dose inhalers, in patients with chronic obstructive pulmonary disease (COPD). |
LD-039-0003 | An open, randomized, parallel-group, multicentre, phase IIIB study to evaluate the efficacy of Symbicort® Turbuhaler® Single Inhaler Therapy (SiT), given as a low maintenance dose once or twice daily plus as needed, compared to a higher maintenance dose of Symbicort Turbuhaler given twice daily plus Oxis® Turbuhaler® as needed during 24 weeks in asthmatic patients |
NIS-RCN-SYM-2006/1 | A 3-month Non-interventional Study of Asthmatics Treated with Symbicort® Turbuhaler® |
NIS-RFI-SYM-2006/1 | INSPIRE Asthma Patient Survey to Clarify the Use of Asthma Medication and Effects of Asthma in Everyday Life in Finland |
SD-039-0348 | Efficacy and safety of budesonide/formoterol Turbuhaler® (80/4.5 mcg b.i.d.) in steroid-using asthmatic adults. |
SD-039-0349 | Efficacy and safety of a fixed combination of budesonide/formoterol Turbuhaler® in inhaled steroid-using asthmatic adults. |
| SD-039-0353 | Efficacy and safety of budesonide/formoterol Turbuhaler® in a fixed combination in steroid-using asthmatic children. |
| SD-039-0617 | Onset of Action of Symbicort Turbuhaler® compared with Seretide Diskus™ in asthmatic patients. |
| SD-039-0618 | Efficacy of Symbicort Turbuhaler® compared with fluticasone DiskusTM in asthmatic patients. |
| SD-039-0629 | A placebo-controlled 12 month efficacy study of the fixed combination budesonide/formoterol compared with budesonide and formoterol as monotherapies in patients with chronic obstructive pulmonary disease (COPD). |
| SD-039-0664 | Safety of a combination of budesonide/formoterol in a single inhaler (Symbicort® Turbuhaler®) in steroid-using asthmatic adults. |
| SD-039-0664(B) | Safety of a combination of budesonide/formoterol in a single inhaler (Symbicort® Turbuhaler®) in steroid-using asthmatic adults. |
| SD-039-0665 | Symbicort low dose once daily in mild to moderate asthmatic patients. |
| SD-039-0666 | Symbicort high dose once daily in mild to moderate asthmatic patients. |
| SD-039-0667 | Efficacy and Safety of Symbicort® Turbuhaler® as Single Therapy in Patients with Mild to Moderate Asthma - STEAM |
| SD-039-0668 | Efficacy and safety of Symbicort® (budesonide/formoterol) Turbuhaler® as Single Therapy in subjects with moderate-severe asthma. Comparison with conventional asthma therapy, Pulmicort®(budesonide) Turbuhaler® as regular treatment complemented with Bricanyl®(terbutaline) Turbuhaler®. |
| SD-039-0670 | A placebo-controlled 12-month efficacy study of the fixed combination budesonide/formoterol compared to budesonide and formoterol as monotherapies in patients with Chronic Obstructive Pulmonary Disease (COPD). |
| SD-039-0671 | Efficacy of Symbicort Turbuhaler® compared with fluticasone Diskus™ in asthmatic patients not using steroids. |
| SD-039-0673 | Efficacy and safety of budesonide/formoterol (Symbicort) Turbuhaler® as Single Therapy in patients with mild-moderate asthma. Comparison with Symbicort Turbuhaler and Pulmicort®Turbuhaler as maintenance therapy, both complemented with Bricanyl®Turbuhaler (STAY). |
| SD-039-0681 | A randomised, double-blind, parallel-group, multicentre phase-III study to compare the efficacy and safety of Symbicort® pMDI (budesonide/formoterol 160/4.5 mcg 2 actuations b.i.d., delivered dose) with that of Pulmicort® pMDI (budesonide 200 mcg 2 actuations b.i.d., metered dose) and Symbicort Turbuhaler® (budesonide/formoterol 160/4.5 mcg 2 inhalations b.i.d., delivered dose) in adolescents and adults with asthma. |
| SD-039-0682 | A 12-week randomised, double-blind, parallel-group, multicentre phase-III study to compare the efficacy and safety of Symbicort® pMDI (budesonide/formoterol 80/4.5 mcg 2 actuations b.i.d., delivered dose) with that of Pulmicort® pMDI (budesonide 100 mcg 2 actuations b.i.d., metered dose) and Symbicort Turbuhaler® (budesonide/formoterol 80/4.5 mcg 2 actuations b.i.d., delivered dose) in children with asthma. |
| SD-039-0686 | A randomized, double-dummy, double-blind/open, parallel-group, phase-III, multicentre, 7-month study to assess the efficacy and safety of Symbicort® Turbuhaler® (budesonide/formoterol; 160/4.5 mcg delivered dose) given either as standard therapy (2 inhal. b.i.d.) or with an adjustable dosing regimen (1, 2 or 4 inhal. b.i.d.) versus Seretide™ Diskus™ (salmeterol/fluticasone; 50/250 mcg metered dose) given as standard therapy (1 inhal. b.i.d.) in adult and adolescent asthmatic patients. |
| SD-039-0688 | Efficacy and safety of Symbicort® (budesonide/formoterol 80/4.5 mcg, 2 inhal. b.i.d.) compared to Pulmicort® (budesonide 100 mcg, 2 inhal. b.i.d.) and Pulmicort (budesonide 100 mcg, 2 inhal. b.i.d.) plus Oxis® (formoterol 4.5 mcg, 2 inhal. b.i.d.) all delivered via Turbuhaler® in steroid using asthmatic children. A double-blind, double-dummy, randomised, parallel-group, phase III, multicentre 12-week study. |
| SD-039-0689 | Efficacy and safety of Symbicort® (budesonide/ formoterol) 1280/36 mcg daily delivered dose compared to Pulmicort® (budesonide) 1600 mcg metered dose and Pulmicort (budesonide) 1600 mcg metered dose plus Oxis® (formoterol) 36 mcg delivered dose all delivered via Turbuhaler® in steroid-using asthmatic adolescents and adults. A double-blind, double-dummy, randomized, parallel group, phase III, multicentre study. |
| SD-039-0691 | A comparison of the effectiveness of treatment with Symbicort® Turbuhaler® (budesonide/formoterol; 160/4.5 mcg) Single Inhaler Therapy and Seretide™ Diskus™ (salmeterol/fluticasone; 50/100, 50/250 or 50/500 mcg) plus Ventoline™ (salbutamole) as needed in steroid-treated adult and adolescent asthmatic subjects. A randomised, open, parallel-group, phase IIIB, multicentre, 12-month study. |
| SD-039-0698 | Effects of high dose inhaled budesonide+ formoterol versus placebo and oral prednisolone on biomarkers of airway inflammation in the treatment of exacerbations in non-hospitalised patients with mild to moderate COPD. |
| SD-039-0714 | Efficacy and safety of budesonide/formoterol Turbuhaler® (160/4.5 mcg b.i.d. delivered dose) compared to budesonide Turbuhaler® (200 mcg b.i.d. metered dose) in steroid-using asthmatic adolescent patients. A double-blind, double-dummy, randomised, parallel group, phase III, multicentre study |
| SD-039-0715 | An open, parallel-group, randomised, multi-centre phase IIIstudy to compare the long-term (52-week) safety of Symbicort®(budesonide/ formoterol) pMDI 160/4.5 mcg 2 actuations b.i.d. withthat of Symbicort Turbuhaler® 160/4.5 mcg 2 inhalations b.i.d. inadults and adolescents with asthma |
SD-039-0716 | A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of SYMBICORT® pMDI (80/4.5 mcg) versus its Monoproducts (budesonide and formoterol) in Children (³6 Years of Age) and Adults with Asthma. |
SD-039-0717 | A Twelve Week, Randomized, Double Blind, Double Dummy, Placebo Controlled Trial of SYMBICORT® (160/4.5 mcg) versus its Mono Products (budesonide and formoterol) in Adolescents (³12 Years of Age) and Adults with Asthma. |
SD-039-0718 | A Twelve-Week, Randomized, Double-Blind, Double-Dummy Trial of Symbicort® (40/4.5 mcg) versus its Mono-Products (budesonide and formoterol) in Asthmatic Children Aged Six to Fifteen Years - SEEDLING 40/4.5 |
SD-039-0719 | A Six-Month, Randomized, Open-Label Safety Study of SYMBICORT® (160/4.5 mcg) Compared to PULMICORT Turbuhaler® in Asthmatic Children Aged 6 to 11 Years. |
SD-039-0725 | 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. |
SD-039-0726 | 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. |
SD-039-0728 | A 52-week, randomized, double-blind, single-dummy, parallel-group, multicenter Phase III study comparing the long-term safety of SYMBICORT® pMDI 160/4.5 mcg x 4 actuations twice daily to SYMBICORT® pMDI 160/4.5 mcg x 2 actuations twice daily and budesonide HFA pMDI 160 mcg x 4 actuations twice daily in adult and adolescent subjects with asthma. |
| SD-039-0734 | Efficacy of Symbicort® Turbuhaler® 160/4.5 mcg as needed versus Oxis® 4.5 mcg as needed and Bricanyl® 0.4 mg as needed in adults and adolescents with asthma receiving Symbicort® Turbuhaler® 160/4.5 mcg twice daily as maintenance treatment. A 12-month, randomised, double-blind, parallel-group, active-controlled, phase IIIB, multi-centre study. |
| SD-039-0735 | Comparison of the efficacy and safety of one inhalation of Symbicort® Turbuhaler® 160/4.5 mcg bid plus as-needed with two inhalations of SeretideTM EvohalerTM 25/125 mcg bid plus Terbutaline Turbuhaler® 0.4 mg as-needed, and one inhalation of Symbicort® Turbuhaler® 320/9 mcg bid plus Terbutaline Turbuhaler® 0.4 mg as-needed. A 6-month, randomised, double-blind, double-dummy, parallel-group, active-controlled, multicentre, phase IIIB study in adult and adolescent asthmatic patients. |
| SRP-RB-COPD-2005/1 | A Scientific Research Program to evaluate the effects of
SYMBICORT 320/9μg® in the treatment of COPD in real life environment by General Practitioners. |