Comparison · NCT00975195-sae
Fluticasone Maintenance vs Fluticasone Withdrawal: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Fluticasone Maintenance vs Fluticasone Withdrawal: serious adverse events. Trial comparisons, record NCT00975195-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00975195-sae
On this page
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 | 0.235 | 0.212 | 0.259 | wilson | |
| Risk in group 2 | 0.242 | 0.219 | 0.266 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00663 | -0.0401 | 0.0269 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.973 | 0.845 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 0.964 | 0.802 | 1.16 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Fluticasone Maintenance than on Fluticasone Withdrawal | 151 | from the risk difference interval | the interval includes no difference |
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 | Fluticasone Maintenance | 18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period). | 292 | 1,243 | EG000 |
| Group 2 | Fluticasone Withdrawal | 18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period). | 300 | 1,242 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
Source ClinicalTrials.gov
Trial
- Title
- Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
- NCT number
- NCT00975195
- Phases
- PHASE4
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- tiotropium inhalation, salmeterol xinafoate, fluticasone propionate, placebo matched for fluticasone propionate
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2015-02-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00975195?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00975195-sae