JPRN-jRCT2080220715UnknownPhase 3
A Comparison of Symbicort SMART (160/4.5mcg) and Symbicort Turbuhaler 160/4.5mcg, Plus Terbutaline Turbuhaler 0.4mg as Needed, for Treatment of Asthma - a 12-Month, Randomized, Double-Blind, Parallel Group, Active-Controlled, Multinational Phase 3 Study in Asthmatic Patients From 16 Years
Conditions
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- AstraZeneca
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 16age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •Diagnosis of asthma according to GINA 2007 with a documented history of at least 6 months duration
- •- Turbuhaler-Prescribed use of inhaled GCS (any brand) for at least 12 weeksAges
- •- Reversible airway obstruction, defined as an increase in 12% of FEV1 or more relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline
Exclusion Criteria
- •- Respiratory infection affecting the asthma, as judged by the investigator within 4 weeks
- •- Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks
Investigators
Similar Trials
Completed
Not Applicable
Study to Investigate the Efficacy of Symbicort® SMART. SAKURA-J45J45PER-017-09ASTRAZENECA - PERU,55
Completed
Phase 3
Study to Investigate the Efficacy of Symbicort® SMART.AsthmaNCT00839800AstraZeneca2,091
Active, not recruiting
Not Applicable
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 treatment of persistent asthma in adolescents and adults. A randomised, open, parallel-group, multicentre, 26 weeks study - MONOEUCTR2004-000679-32-FIAstraZeneca Oy1,900
Active, not recruiting
Not Applicable
A comparison of Symbicort® Maintenance and Reliever Therapy (Symbicort Turbuhaler® 160/4.5 mg, one inhalation bid plus as-needed) and Symbicort Turbuhaler 160/4.5 mg, one inhalation bid plus terbutaline Turbuhaler 0.4 mg/inhalation as needed, for treatment of asthma – a 12-month, randomized, double-blind, parallel group, active-controlled, multinational phase III study in asthmatic patients aged 16 years and above. - SAKURAAsthmaEUCTR2008-006869-86-HUAstraZeneca AB2,400
Active, not recruiting
Not Applicable
A comparison of Symbicort Single inhaler Therapy (Symbicort Turbuhaler 160/4.5 mg, 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, multicentre study - STYLEThis is a Phase IIIB trial to be conducted in patients with persistent asthmaMedDRA version: 7.0Level: LLTClassification code 10003553EUCTR2005-000532-25-LTAstraZeneca AB1,000