Tiotropium vs Salmeterol: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.147 | 0.136 | 0.159 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.165 | 0.154 | 0.178 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0181 | -0.0347 | -0.00158 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.89 | 0.8 | 0.99 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.871 | 0.768 | 0.988 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with a serious adverse event on Tiotropium than on Salmeterol | 55.1 | 28.8 | 632 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | Tiotropium | Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID) | 545 | 3,707 | EG000 | ClinicalTrials.gov |
| Group 2 | Salmeterol | Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily | 606 | 3,669 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | 52 weeks (while on treatment with study drugs + 30 days) | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients. | ClinicalTrials.gov |
| NCT number | NCT00563381 | ClinicalTrials.gov |
| Phases | PHASE4 | ClinicalTrials.gov |
| Conditions | Pulmonary Disease, Chronic Obstructive | ClinicalTrials.gov |
| Interventions | Tiotropium bromide, Salmeterol, Placebo Salmeterol, Placebo Tiotropium | ClinicalTrials.gov |
| Lead sponsor | Boehringer Ingelheim | ClinicalTrials.gov |
| Results first posted | 2011-05-17 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00563381?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.