Comparison · NCT01337336-8dba9506
FSC Cohort vs AC Cohort: Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. FSC Cohort vs AC Cohort: Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation. Trial comparisons, record NCT01337336-8dba9506. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01337336-8dba9506
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.186 | 0.163 | 0.21 | wilson | |
| Risk in group 2 | 0.231 | 0.216 | 0.246 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0451 | -0.0721 | -0.0165 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.805 | 0.698 | 0.927 | log | |
| Odds ratio, group 1 over group 2 | 0.76 | 0.637 | 0.906 | log | |
| Number needed to treat, for one fewer participant with the outcome on FSC Cohort than on AC Cohort | 22.2 | 13.9 | 60.5 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | FSC Cohort | Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day | 200 | 1,078 | OG000 |
| Group 2 | AC Cohort | Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available. | 674 | 2,923 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation
- Description
The number of participants with any of the following COPD-related exacerbations during the follow-up period was computed: COPD-related hospitalization, emergency room (ER) visit, or physician visit with a prescription (Rx) for oral corticosteroid (OCS) or antibiotic within 5 days of the visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.
- Time frame
- Maximum of 1 year after index date (January 1, 2004 to June 30, 2009)
- Population
Managed care enrollees (aged \>=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).
Source ClinicalTrials.gov
Trial
- Title
Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a COPD-Comorbid Depression/Anxiety Population
- NCT number
- NCT01337336
- Phases
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- fluticasone propionate/salmeterol xinafoate, Anticholinergics
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2011-05-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01337336?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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