Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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| Tracking Information | |||||
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| First Received Date ICMJE | June 23, 2011 | ||||
| Last Updated Date | March 15, 2012 | ||||
| Start Date ICMJE | August 2009 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
HOSPITALIZATION/ER VISIT [ Time Frame: July 1, 2004 to September 30, 2006 (up to 2 years) ] [ Designated as safety issue: No ] HOSPITALIZATION/ER VISIT related to COPD as well as oral steroids/antibiotics treatment associated with adherence |
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| Change History | Complete list of historical versions of study NCT01381471 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD) | ||||
| Official Title ICMJE | Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD) | ||||
| Brief Summary | The specific aim of this study is to describe 1 year Advair dispensing rates for patients with COPD, and to measure the association between Advair adherence and healthcare utilization (e.g. emergency room visits and inpatient admissions, etc.). To compare the risk of a COPD exacerbation (moderate or severe) during a 3-month follow-up period between patients thqat are adherent versus those that are not. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients 40 years of age or older with at least one pharmacy claim for FSC during the index date range (July 1, 2005 through June 30, 2006). An index date was designated as the date of the first pharmacy claim for FSC. Patients were also required to have continuous medical and pharmacy eligibility for the 12 month pre-Index year and the 12 month Index year (referred to as the 24 month observation period), and the 3 month post-Index outcome period (referred to as the outcome period). Eligible patients were further required to have at least one medical claim with a diagnosis (either primary or secondary) of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, and 496), AND at least 1 pharmacy claim for an anticholinergic medication, both occurring during the12 month pre-index period. |
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| Condition ICMJE | Pulmonary Disease, Chronic Obstructive | ||||
| Intervention ICMJE | Drug: fluticasone propionate/salmeterol xinafoate combination
fluticasone propionate/salmeterol xinafoate combination
Other Name: Advair (TM) |
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| Study Group/Cohort (s) | COPD
Patients with a diagnosis code of COPD
Intervention: Drug: fluticasone propionate/salmeterol xinafoate combination |
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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 | 11060 | ||||
| Completion Date | May 2010 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Gender | Both | ||||
| Ages | 40 Years and older | ||||
| 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 | NCT01381471 | ||||
| Other Study ID Numbers ICMJE | 113865 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | GlaxoSmithKline | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | February 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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