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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 9, 2005 | ||||||||
| Last Updated Date | September 26, 2008 | ||||||||
| Start Date ICMJE | July 2002 | ||||||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Clinical efficacy at the end of treatment | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00170222 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) | ||||||||
| Official Title ICMJE | The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients | ||||||||
| Brief Summary | The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized. The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics. |
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| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Chronic Obstructive Pulmonary Disease | ||||||||
| Intervention ICMJE | Drug: doxycycline | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 258 | ||||||||
| Completion Date | August 2008 | ||||||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 45 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00170222 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | M02-007 | ||||||||
| Study Sponsor ICMJE | Medical Center Alkmaar | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Medical Center Alkmaar | ||||||||
| Verification Date | September 2008 | ||||||||
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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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