| November 29, 2005 |
| March 26, 2009 |
| September 2005 |
| |
| Forced Expiratory Volume in one second (FEV1) |
| Same as current |
| Complete list of historical versions of study NCT00259779 on ClinicalTrials.gov Archive Site |
- Number of patients with treatment failures
- Time to first exacerbation
- Number of patients developing an exacerbation
- Diary cards
- Quality of Life
- - Adverse Events (AEs)
- Serious Adverse Events (SAEs) and Discontinuations due to AEs
- Variables will be assessed before and over the 2+12 weeks treatment period
|
- - Number of patients with treatment failures
- - Time to first exacerbation
- - Number of patients developing an exacerbation
- - Diary cards
- - Quality of Life
- - Adverse Events (AEs)
- Serious Adverse Events (SAEs) and Discontinuations due to AEs
- Variables will be assessed before and over the 2+12 weeks treatment period
|
| |
| Comparison Between Symbicort® and Prednisolone in COPD |
| A Randomised, Double Blind, Double Dummy, Multicentre Phase III Study Comparing the Efficacy of Budesonide/Formoterol (Symbicort® Forte Turbuhaler®) and Oral Prednisolone + Formoterol (Oxis® Turbuhaler) During Two Weeks, in COPD Patients With an Acute Exacerbation, Followed by Twelve Weeks Open Follow up Period With Budesonide/Formoterol (Symbicort Forte Turbuhaler) |
To assess if Symbicort forte Turbuhaler (during two weeks) is as effective as an oral course of prednisolone + Oxis Turbuhaler (during two weeks) for the treatment of an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| Chronic Obstructive Pulmonary Disease |
- Drug: budesonide/formoterol
- Drug: Prednisolone
|
| |
| Ställberg B, Selroos O, Vogelmeier C, Andersson E, Ekström T, Larsson K. Budesonide/formoterol as effective as prednisolone plus formoterol in acute exacerbations of COPD. A double-blind, randomised, non-inferiority, parallel-group, multicentre study. Respir Res. 2009 Feb 19;10:11. |
| |
| Completed |
| 120 |
| July 2007 |
|
Inclusion Criteria:
- Patients with chronic obstructive pulmonary disease and an acute exacerbation
- After the acute treatment a simple pulmonary function test shows a value of 30%-60% of the predicted normal value.
- Patients, who, based on the clinical examination after the initial acute treatment, are candidates for a course of oral steroids for the treatment of acute symptoms due to chronic obstructive pulmonary disease
Exclusion Criteria:
- Diagnosis/history of asthma
- Oxygen uptake (saturation) is <92% after the initial acute treatment
- A requirement for regular use of oxygen therapy
- Regular treatment with any inhaled steroid >1 000 µg/day at study entry
Additional inclusion and exclusion criteria will be evaluated by the investigator |
| Both |
| 40 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Denmark, Finland, Germany, Norway, Sweden |
| |
| NCT00259779 |
|
| D5892L00002, Eudra CT 2005-001090-10, SPACE |
| AstraZeneca |
|
| Study Director: |
AstraZeneca Symbicort Medical Science Director, MD |
AstraZeneca |
|
|
| AstraZeneca |
| March 2009 |
