A Study of the Inflammatory Pathways Associated With Chronic Obstructive Pulmonary Disease Exacerbations
This study has been completed.
Sponsor:
MedImmune LLC
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01337661
First received: April 13, 2011
Last updated: August 27, 2012
Last verified: August 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 13, 2011 | ||||||||
| Last Updated Date | August 27, 2012 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Identification of how inflammatory pathways differ in COPD subjects [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] Identify how inflammatory pathways differ in subjects with COPD during an acute exacerbation relative to when the disease is stable. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01337661 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Biomarker Sample Repository [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] Establish a biomarker sample repository to support future target validation for the treatment of subjects with COPD. |
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| 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 | A Study of the Inflammatory Pathways Associated With Chronic Obstructive Pulmonary Disease Exacerbations | ||||||||
| Official Title ICMJE | An Exploratory Study of the Cellular Inflammatory Mechanisms Associated With Chronic Obstructive Pulmonary Disease Exacerbations | ||||||||
| Brief Summary | The purpose of this study is to observe how the inflammatory pathways differ in subjects with chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD). |
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| Detailed Description | This is an observational study in adult male and female subjects with COPD to collect blood, endobronchial tissues and BAL to investigate the inflammatory genes/pathways associated with AECOPD at the time of exacerbation (ie, active disease) and at 6 weeks later (ie, stable disease). |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Blood, Endobronchial tissues and Bronchoalveolar (BAL) samples |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Subjects referred to the hospital clinic with AECOPD |
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| Condition ICMJE | Chronic Obstructive Pulmonary Disease | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | COPD subjects
Adult male and female subjects with COPD |
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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 | 26 | ||||||||
| Completion Date | February 2012 | ||||||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 40 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Ireland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01337661 | ||||||||
| Other Study ID Numbers ICMJE | CD-RI-INDP-1048 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | MedImmune LLC | ||||||||
| Study Sponsor ICMJE | MedImmune LLC | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | MedImmune LLC | ||||||||
| Verification Date | August 2012 | ||||||||
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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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