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Comparison · NCT00387088-c1c5a67a

Tiotropium vs Placebo: Number of Patients With at Least One COPD 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. Tiotropium vs Placebo: Number of Patients With at Least One COPD Exacerbation. Trial comparisons, record NCT00387088-c1c5a67a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00387088-c1c5a67a

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3530.3320.375wilson
Risk in group 20.4310.4090.453wilson
Risk difference, group 1 minus group 2-0.0779-0.108-0.0472newcombe hybrid score
Risk ratio, group 1 over group 20.8190.7570.887log
Odds ratio, group 1 over group 20.7210.6330.82log
Number needed to treat, for one fewer participant with the outcome on Tiotropium than on Placebo12.89.2321.2from the risk difference interval

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1TiotropiumTiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)6851,939OG000
Group 2PlaceboPlacebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)8421,953OG001

Outcome

Type
SECONDARY
Title
Number of Patients With at Least One COPD Exacerbation
Description
Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
Time frame
During actual study treatment period (planned Day 1 to Day 337)
Population
The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data.

Source ClinicalTrials.gov

Trial

Title
Tiotropium / Respimat One Year Study in COPD.
NCT number
NCT00387088
Phases
PHASE3
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
Respimat, Tiotropium
Lead sponsor
Boehringer Ingelheim
Results first posted
2010-01-22

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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