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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00496470 |
The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease, COPD |
Drug: Symbicort (budesonide/formoterol turbuhaler 320/9ug) Drug: Spiriva (tiotropium bromide 18ug) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A 12-Week, Double-Blind, Randomised, Parallel Group, Multi-Centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva) 18 µg One Inhalation Once Daily |
Estimated Enrollment: | 620 |
Study Start Date: | May 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Tomas Andersson, MD | AstraZeneca R&D Lund |
Principal Investigator: | Tobias Welte, MD | Hannover Medical School |
Study ID Numbers: | D5892C00015, Eudract no:2006-006796-21 |
Study First Received: | July 3, 2007 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00496470 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Poland: Ministry of Health; Slovakia: State Institute for Drug Control; Canada: Canadian Institutes of Health Research; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency |
Chronic Obstructive Pulmonary Disease, COPD |
Lung Diseases, Obstructive Symbicort Respiratory Tract Diseases Bromides Lung Diseases |
Budesonide Formoterol Tiotropium Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Parasympatholytics Respiratory System Agents Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic beta-Agonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Anti-Asthmatic Agents Cholinergic Agents Glucocorticoids Hormones Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |