Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: budesonide/formoterol Turbuhaler 320/9µg (Drug); formoterol Turbuhaler 9µg (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Tomas Andersson, MD, Study Director, Affiliation: AstraZeneca
Heinrich Worth, MD, Principal Investigator, Affiliation: Akademisches Lehrkrankenhaus der Universität Erlangen-Nürnberg, Germany
Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Summary
The purpose of this study is to investigate the effect on exercise tolerance, lung function
and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic
obstructive pulmonary disease.
Clinical Details
Official title: A Multi-Centre, Randomised, Double-Blind, Cross-Over Design Study to Evaluate Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) 320/9µg One Inhalation Twice Daily Compared With Placebo and Oxis 9µg One Inhalation Twice Daily in Patients With Severe COPD.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Exercise Endurance Time (EET) measured at 75% of peak work capacity with cycle ergometry.
Secondary outcome: Exercise Endurance TestDyspnea Score Lung Function Symptoms and Health Status questionnaire Reliever Medication Use Peak Expiratory Flow
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- >=40 years of age
- diagnosed COPD with symptoms >= 2 years
- pre-bronchodilatory FEV1 <=50% of PN
Exclusion Criteria:
- Current respiratory tract disorder other than COPD
- history of asthma or rhinitis
- significant or unstable cardiovascular disorder
Locations and Contacts
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Research Site, BERLIN, Germany; Recruiting
Research Site, ERFURT, Germany; Recruiting
Research Site, FULDA, Germany; Recruiting
Research Site, FURTH, Germany; Recruiting
Research Site, GEESTHACHT, Germany; Recruiting
Research Site, GROBHANSDORF, Germany; Not yet recruiting
Research Site, LEIPZIG, Germany; Recruiting
Research Site, NEURUPPIN, Germany; Recruiting
Research Site, WIESBADEN, Germany; Not yet recruiting
Research Site, BASEL, BASEL STADT, Switzerland; Recruiting
Additional Information
AstraZeneca Clinical Trial Information - Outside US
Starting date: May 2007
Ending date: June 2008
Last updated: March 27, 2008
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