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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00379028 |
The purpose of the study is to evaluate how the airways in COPD patients, compared to healthy volunteers, absorb steroid drugs from Symbicort Turbuhaler and Seretide Diskus. The blood concentrations of the steroids will be used as surrogate marker.
Condition | Intervention | Phase |
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Chronic Obstructive Pulmonary Disease |
Drug: Budesonide/Formoterol Turbuhaler Drug: Salmeterol/Fluticasone Diskus |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Randomized, Double-Blind, Two-Way Cross-Over Study Evaluating Systemic Bioavailability and Airway Clearance of SymbicortTurbuhaler 320/9mcg vs SeretideDiskus 50/500mcg After Single Inhalations in Patients With COPD and Healthy Volunteers |
Enrollment: | 54 |
Study Start Date: | September 2006 |
Study Completion Date: | July 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
Research Site | |
Lund, Sweden | |
United Kingdom | |
Research Site | |
Nottingham, United Kingdom |
Study Director: | Christer Hultquist, MD | AstraZeneca |
Principal Investigator: | Tim Harrisson, MD | Nottingham University |
Study ID Numbers: | D5892C00012, EUDRACT 2006-002412-10 |
Study First Received: | September 20, 2006 |
Last Updated: | March 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00379028 History of Changes |
Health Authority: | Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
COPD |
Anti-Inflammatory Agents Salmeterol Symbicort Budesonide Anti-Asthmatic Agents Anti-Allergic Agents Healthy Lung Diseases, Obstructive |
Respiratory Tract Diseases Lung Diseases Fluticasone Formoterol Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Respiratory System Agents Symbicort Physiological Effects of Drugs Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Lung Diseases, Obstructive Respiratory Tract Diseases |
Autonomic Agents Therapeutic Uses Lung Diseases Fluticasone Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |