Trial · NCT00563381
Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients.
NCT00563381, Phase 4, Completed, Boehringer Ingelheim; results first posted 2011-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients. Trials, record NCT00563381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00563381
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients.
- NCT number
- NCT00563381
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 7,376 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Tiotropium bromide, Salmeterol, Placebo Salmeterol, Placebo Tiotropium
- First posted
- 2007-11-26
- Last updated
- 2013-12-24
- Other registries' IDs
- eudract:2007-001840-33
- Results first posted
- 2011-05-17
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | First Occurrence of (Moderate or Severe) COPD Exacerbation | 52 weeks | First occurrence analysed by Cox regression as time to first exacerbation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). |
| Secondary | COPD Exacerbations Per Patient-year Leading to Hospitalisation | 52 weeks | An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). |
| Secondary | Number of Participants With at Least One COPD Exacerbation | 52 weeks | An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). |
| Secondary | COPD Exacerbations Per Patient-year | 52 weeks | |
| Secondary | First Occurrence of COPD Exacerbation Leading to Hospitalization | 52 weeks | First occurrence analysed by Cox regression as time to first exacerbation leading to hospitalisation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). |
| Secondary | Number of Participants With at Least One COPD Exacerbation Leading to Hospitalisation | 52 weeks | An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). |
| Secondary | Occurrence of Premature Discontinuation of Trial Medication | 52 weeks | Occurrence analysed by Cox regression as time to premature discontinuation of trial medication and reported as hazard ratio |
| Secondary | Number of Participants With Premature Discontinuation of Trial Medication | 52 weeks | |
| Secondary | First Occurrence of COPD Exacerbation or Discontinuation of Trial Medication Because of Worsening of Underlying Disease, Whichever Comes First | 52 weeks | First occurrence analysed by Cox regression as time to first exacerbation or discontinuation of trial medication because of worsening of underlying disease, whichever comes first and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). |
| Secondary | First Occurrence of COPD Exacerbations Treated With Systemic Steroids | 52 weeks | First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | First Occurrence of (Moderate or Severe) COPD Exacerbation | 52 weeks | All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment | number of first occurrences | NUMBER |
| SECONDARY | COPD Exacerbations Per Patient-year Leading to Hospitalisation | 52 weeks | All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment | Hospitalizations per patient-year | MEAN |
| SECONDARY | Number of Participants With at Least One COPD Exacerbation | 52 weeks | All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment | Participants | NUMBER |
| SECONDARY | COPD Exacerbations Per Patient-year | 52 weeks | All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment | exacerbations per patient-year | MEAN |
| SECONDARY | First Occurrence of COPD Exacerbation Leading to Hospitalization | 52 weeks | All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment | number of first occurrences | NUMBER |
| SECONDARY | Number of Participants With at Least One COPD Exacerbation Leading to Hospitalisation | 52 weeks | All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment | Participants | NUMBER |
| SECONDARY | Occurrence of Premature Discontinuation of Trial Medication | 52 weeks | All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment | number of first occurrences | NUMBER |
| SECONDARY | Number of Participants With Premature Discontinuation of Trial Medication | 52 weeks | All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment | Participants | NUMBER |
| SECONDARY | First Occurrence of COPD Exacerbation or Discontinuation of Trial Medication Because of Worsening of Underlying Disease, Whichever Comes First | 52 weeks | All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment | number of first occurrences | NUMBER |
| SECONDARY | First Occurrence of COPD Exacerbations Treated With Systemic Steroids | 52 weeks | All patients who received study medication, were randomised, and were documented to have taken at least one dose of double-blind treatment | number of first occurrences | NUMBER |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| First Occurrence of (Moderate or Severe) COPD Exacerbation | Tiotropium | 1277 | number of first occurrences | ||
| First Occurrence of (Moderate or Severe) COPD Exacerbation | Salmeterol | 1414 | number of first occurrences | ||
| COPD Exacerbations Per Patient-year Leading to Hospitalisation | Tiotropium | 0.09 | 95% Confidence Interval 0.09 to 0.10 | Hospitalizations per patient-year | |
| COPD Exacerbations Per Patient-year Leading to Hospitalisation | Salmeterol | 0.13 | 95% Confidence Interval 0.12 to 0.14 | Hospitalizations per patient-year | |
| Number of Participants With at Least One COPD Exacerbation | Tiotropium | Participants with (at least one) event | 1277 | Participants | |
| Number of Participants With at Least One COPD Exacerbation | Salmeterol | Participants with (at least one) event | 1414 | Participants | |
| Number of Participants With at Least One COPD Exacerbation | Tiotropium | Participants with no event | 2430 | Participants | |
| Number of Participants With at Least One COPD Exacerbation | Salmeterol | Participants with no event | 2255 | Participants | |
| COPD Exacerbations Per Patient-year | Tiotropium | 0.64 | 95% Confidence Interval 0.61 to 0.67 | exacerbations per patient-year | |
| COPD Exacerbations Per Patient-year | Salmeterol | 0.72 | 95% Confidence Interval 0.68 to 0.75 | exacerbations per patient-year |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tiotropium | 3,707 | |
| Overall Study | STARTED | Salmeterol | 3,669 | |
| Overall Study | COMPLETED | Tiotropium | 3,122 | |
| Overall Study | COMPLETED | Salmeterol | 3,021 | |
| Overall Study | NOT COMPLETED | Tiotropium | 585 | |
| Overall Study | NOT COMPLETED | Salmeterol | 648 |
Source ClinicalTrials.gov
Adverse events866
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Tiotropium | 495 | 3,707 | |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Salmeterol | 581 | 3,669 | |
| serious | Anaemia | Blood and lymphatic system disorders | Tiotropium | 1 | 3,707 | |
| serious | Anaemia | Blood and lymphatic system disorders | Salmeterol | 3 | 3,669 | |
| serious | Haemorrhagic anaemia | Blood and lymphatic system disorders | Tiotropium | 1 | 3,707 | |
| serious | Haemorrhagic anaemia | Blood and lymphatic system disorders | Salmeterol | 0 | 3,669 | |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | Tiotropium | 1 | 3,707 | |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | Salmeterol | 0 | 3,669 | |
| serious | Lymphadenopathy | Blood and lymphatic system disorders | Tiotropium | 0 | 3,707 | |
| serious | Lymphadenopathy | Blood and lymphatic system disorders | Salmeterol | 1 | 3,669 |
1 to 10 of 866Source ClinicalTrials.gov
See all 866 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tiotropium | ||
| Total, all-cause mortality | Salmeterol | ||
| Total, other adverse events | Tiotropium | 495 | 3,707 |
| Total, other adverse events | Salmeterol | 581 | 3,669 |
| Total, serious adverse events | Tiotropium | 545 | 3,707 |
| Total, serious adverse events | Salmeterol | 606 | 3,669 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tiotropium vs Salmeterol: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00563381
GET https://conductscience.org/api/trials/v1/NCT00563381/registered?page=2