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Clinical trials for Symbicort

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44393   clinical trials with a EudraCT protocol, of which   7405   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    78 result(s) found for: Symbicort. Displaying page 2 of 4.
    EudraCT Number: 2008-004833-70 Sponsor Protocol Number: BUSAL-III-08-1 Start Date*: 2009-01-16
    Sponsor Name:Laboratoires SMB S.A.
    Full Title: A phase III, randomized, parallel group, open study to compare the therapeutic efficacy and safety of SMB BUDESONIDE-SALMETEROL DPI capsule 150/25μg BID delivered by the AXAHALER® versus SYMBICORT®...
    Medical condition: Patients with moderate to severe persistent asthma.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10049106 Asthma chronic LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2005-003297-13 Sponsor Protocol Number: D5892N00005 Start Date*: 2005-12-01
    Sponsor Name:Imperial College
    Full Title: A randomised, double-blind, placebo-controlled, parallel-group study to investigate the effect of Symbicort® and Pulmicort® on HAT and HDAC expression and activity in induced sputum cells obtained ...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-002790-28 Sponsor Protocol Number: D5896C00027 Start Date*: 2011-11-23
    Sponsor Name:AstraZeneca AB
    Full Title: A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) SE (Completed) CZ (Completed) BG (Completed) IT (Completed) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-000679-32 Sponsor Protocol Number: D5890L00008 Start Date*: 2005-05-04
    Sponsor Name:AstraZeneca Oy
    Full Title: A comparison of the efficacy of Symbicort Single inhaler Therapy (Symbicort Turbuhaler 160/4.5 microg, one inhalation twice a day plus as-needed) and conventional best standard treatment for the tr...
    Medical condition: This is a Phase IIIB trial to be conducted in patients with persistent asthma.
    Disease: Version SOC Term Classification Code Term Level
    7.0 10003553 LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2004-001724-20 Sponsor Protocol Number: D5899C00748 Start Date*: 2004-10-08
    Sponsor Name:AstraZeneca AB
    Full Title: A randomised, placebo-controlled, double-blind, double-dummy, crossover study to assess the onset of action of two inhalations of Symbicort 160/4.5μg compared with two inhalations of Seretide 25/2...
    Medical condition: This is an application for a phase III study to be conducted in COPD patients.
    Disease: Version SOC Term Classification Code Term Level
    10010952
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2020-001521-31 Sponsor Protocol Number: D5982C00008 Start Date*: 2021-04-20
    Sponsor Name:AstraZeneca AB
    Full Title: A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter 24 to 52 Week Variable Length Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Me...
    Medical condition: Severe and inadequately controlled asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Trial now transitioned) DE (Trial now transitioned) CZ (Trial now transitioned) PT (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2013-004474-96 Sponsor Protocol Number: D589SC00001 Start Date*: 2014-05-08
    Sponsor Name:AstraZeneca AB
    Full Title: A 52-week, double-blind, randomised, multi-centre, parallel-group,Phase III study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort® (budesonide/formoterol...
    Medical condition: Asthma
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: HU (Completed) GB (Completed) PL (Completed) RO (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2013-004630-14 Sponsor Protocol Number: BFS-AS-40035 Start Date*: 2014-01-23
    Sponsor Name:Teva Branded Pharmaceutical Products R&D, Inc.
    Full Title: A 12 Week, Randomized, Open-Label, Parallel Group Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) Spiromax(160/4.5 and 320/9 mcg) as Compared to SYMBICORT® TURBOHA...
    Medical condition: Persistent asthma
    Disease: Version SOC Term Classification Code Term Level
    17.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038738 Respiratory, thoracic and mediastinal disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-018316-32 Sponsor Protocol Number: D589GC00002 Start Date*: 2010-11-23
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase 2, randomized, blinded, 5-period cross-over, placebo and activecontrolled, multicenter, dose-finding study of single doses of formoterol 2.25 μg, 4.5 μg, and 9 μg delivered via Symbicort pM...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    12.1 10003553 Asthma LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2004-001107-36 Sponsor Protocol Number: D5890L00009 Start Date*: 2004-11-19
    Sponsor Name:AstraZeneca NV/SA
    Full Title: A comparison of Symbicort Single inhaler Therapy (Symbicort Turbohaler 160/4.5 mg, 1 inhalation b.i.d. plus as needed) and conventional best practice for the treatment of persistent asthma in adole...
    Medical condition: persistent asthma
    Disease: Version SOC Term Classification Code Term Level
    7.0 10003553
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2004-001168-28 Sponsor Protocol Number: D5899C00001 Start Date*: 2005-01-04
    Sponsor Name:AstraZeneca AB
    Full Title: A 12-month, double-blind, double-dummy, randomized, parallel group, multicenter efficacy and safety study of Symbicort® pMDI 2x160/4.5μg bid and 2x80/4.5 μg bid compared to Formoterol Turbuhaler 2x...
    Medical condition: This is an application for a phase III study to be conducted in COPD patients.
    Disease: Version SOC Term Classification Code Term Level
    10010952
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) HU (Completed) IS (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-002722-29 Sponsor Protocol Number: D5897C00004 Start Date*: 2007-08-15
    Sponsor Name:AstraZeneca AB
    Full Title: A 4-week, open-label, randomized, multi-centre, parallel-group study evaluating the safety and efficacy of 4 actuations Symbicort (budesonide/formoterol) HFA pMDI 40/2.25ug twice daily, with and wi...
    Medical condition: asthma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003553 Asthma LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2008-006768-13 Sponsor Protocol Number: SAM109780 Start Date*: 2008-12-18
    Sponsor Name:GlaxoSmithKline AB
    Full Title: Follow-up survey for comparing stable dosing with a symptom based “as needed-regimen” in moderate and severe persitent asthma.
    Medical condition: Moderate and severe persistent asthma.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003553 Asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2004-001183-41 Sponsor Protocol Number: D5899C00002 Start Date*: 2005-02-14
    Sponsor Name:AstraZeneca AB
    Full Title: A 6-month, double-blind, double-dummy, randomised, parallel group, multicenter, efficacy and safety study of Symbicort® pMDI 2x160/4.5μg and 2x80/4.5μg bid compared to Formoterol Turbuhaler, Budes...
    Medical condition: This is an application for a phase III study to be conducted in COPD patients.
    Disease: Version SOC Term Classification Code Term Level
    10010952
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2005-000372-41 Sponsor Protocol Number: D5890L00012 Start Date*: 2005-06-19
    Sponsor Name:AstraZeneca UK Limited
    Full Title: Real life effectiveness in asthma of Symbicort® Single Inhaler Therapy (RELEASE)
    Medical condition: This is a Phase IIIb Trial to be conducted in adult, uncontrolled asthmatic patients.
    Disease: Version SOC Term Classification Code Term Level
    10003553
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-001029-34 Sponsor Protocol Number: 2014-BUDFOR-EL-47 Start Date*: 2015-10-07
    Sponsor Name:ELPEN Pharmaceutical Co. Inc
    Full Title: Evaluation of the effect of the inhaled combination budesonide -formoterol (Pulmoton® Elpenhaler®) in exhaled nitric oxide (FeNO) of patients with bronchial asthma.
    Medical condition: Bronchial Asthma
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-020407-73 Sponsor Protocol Number: D9830C00008 Start Date*: 2010-10-27
    Sponsor Name:AstraZeneca AB
    Full Title: A double-blind, placebo-controlled, randomised, parallel-group, phase-II, multi-centre study to assess the efficacy, safety and tolerability of 4 twice daily doses and 2 once daily doses of AZD1981...
    Medical condition: asthma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed)
    Trial results: View results
    EudraCT Number: 2009-016502-16 Sponsor Protocol Number: PML_DOC_0905_/_ISSSYMB0020 Start Date*: 2009-12-02
    Sponsor Name:University Hospital Antwerp : Department Respiratory Medicine
    Full Title: A randomized, double-blind, placebo-controlled, two way cross-over study to assess the particle deposition and acute effects of formoterol and budesonide combination therapy (Symbicort® forte Turbo...
    Medical condition: COPD
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-002412-10 Sponsor Protocol Number: D5892C00012 Start Date*: 2007-04-25
    Sponsor Name:AstraZeneca AB
    Full Title: A randomized, double-blind, double-dummy, two-way cross-over study evaluating systemic bioavailability and airway clearance of Symbicort® Turbuhaler® 320/9μg/inhalation versus Seretide™ Diskus ™...
    Medical condition: This is a Clinical Pharmacology study to be conducted in one patient group with severe COPD and one group of healthy volunteers.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-005707-26 Sponsor Protocol Number: CCD-0812-PR-0003 Start Date*: 2008-12-30
    Sponsor Name:Chiesi Farmaceutici SpA
    Full Title: Effect of beclomethasone dipropionate/formoterol fumarate (BDP+FF) administered as a fixed pMDI combination on lung impedance and exhaled nitric oxide in comparison with the fixed combination of bu...
    Medical condition: Bronchial Asthma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003553 Asthma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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