Symbicort in Chronic Obstructive Pulmonary Disease (SYMBOL)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00611520
First received: January 29, 2008
Last updated: January 27, 2011
Last verified: January 2011
| Tracking Information | |||||
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| First Received Date ICMJE | January 29, 2008 | ||||
| Last Updated Date | January 27, 2011 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | December 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00611520 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
to get further insight into the details of the use , dosage scheme and duration of treatment with budesonide /formoterol in this population | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Symbicort in Chronic Obstructive Pulmonary Disease | ||||
| Official Title ICMJE | Symbicort in Chronic Obstructive Pulmonary Disease | ||||
| Brief Summary | Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. pneumologists and internists) are asked to document relevant data related to the budesonide/formoterole therapy in patients with COPD. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients |
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| Condition ICMJE | Chronic Obstructive Pulmonary Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1
Patients with COPD treated with budesonide/formoterol |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 64730 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | December 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00611520 | ||||
| Other Study ID Numbers ICMJE | 1312005009 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr Kai Richter, AstraZeneca Germany | ||||
| Study Sponsor ICMJE | AstraZeneca | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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