Trial · NCT00387088
Tiotropium / Respimat One Year Study in COPD.
NCT00387088, Phase 3, Completed, Boehringer Ingelheim; results first posted 2010-01-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tiotropium / Respimat One Year Study in COPD. Trials, record NCT00387088. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00387088
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tiotropium / Respimat One Year Study in COPD.
- NCT number
- NCT00387088
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,991 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Respimat, Tiotropium
- First posted
- 2006-10-12
- Last updated
- 2014-05-16
- Results first posted
- 2010-01-22
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 | Baseline and Day 337 | Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration). |
| Primary | Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | During actual study treatment period (planned Day 1 to Day 337) | Time to first 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 is days from start of study treatment to onset of exacerbation. |
| Secondary | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29 | Baseline and Day 29 | Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug. |
| Secondary | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169 | Baseline and Day 169 | Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug. |
| Secondary | Number of COPD Exacerbations Per Patient - Exposure Adjusted | During actual study treatment period (planned Day 1 to Day 337) | Number of COPD exacerbations (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) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure) |
| Secondary | Number of COPD Exacerbations Per Patient - naïve Estimate | During actual study treatment period (planned Day 1 to Day 337) | Number of COPD exacerbations (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) per patient not adjusted for treatment exposure (i.e. naïve estimate) |
| Secondary | Number of Patients With at Least One COPD Exacerbation | During actual study treatment period (planned Day 1 to Day 337) | 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) |
| Secondary | Time to First Hospitalisation for COPD Exacerbation | During actual study treatment period (planned Day 1 to Day 337) | Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation |
| Secondary | Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted | During actual study treatment period (planned Day 1 to Day 337) | Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure) |
| Secondary | Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate | During actual study treatment period (planned Day 1 to Day 337) | Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate) |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 | Baseline and Day 337 | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data. | Litres | LEAST_SQUARES_MEAN |
| PRIMARY | Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | Days | MEDIAN |
| SECONDARY | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29 | Baseline and Day 29 | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 147 participants from the FAS were excluded due to insufficient FEV1 data. | Litres | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169 | Baseline and Day 169 | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. 133 participants from the FAS were excluded due to insufficient FEV1 data. | Litres | LEAST_SQUARES_MEAN |
| SECONDARY | Number of COPD Exacerbations Per Patient - Exposure Adjusted | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | COPD exacerbations per year | MEDIAN |
| SECONDARY | Number of COPD Exacerbations Per Patient - naïve Estimate | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | COPD exacerbations | MEDIAN |
| SECONDARY | Number of Patients With at Least One COPD Exacerbation | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | participants | NUMBER |
| SECONDARY | Time to First Hospitalisation for COPD Exacerbation | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | Days | MEDIAN |
| SECONDARY | Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | hospitalisations for COPD exacerbations | MEDIAN |
| SECONDARY | Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate | During actual study treatment period (planned Day 1 to Day 337) | The FAS was made up of all randomised and treated participants excluding 99 patients with questionable data. | hospitalisations for COPD exacerbations | MEDIAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 | Tiotropium | 0.119 | Standard Error 0.007 | Litres | |
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 | Placebo | 0.018 | Standard Error 0.007 | Litres | |
| Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Tiotropium | NA | 95% Confidence Interval NA to NA | Days | |
| Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | Placebo | NA | 95% Confidence Interval 354.0 to NA | Days | |
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29 | Tiotropium | 0.11 | Standard Error 0.005 | Litres | |
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29 | Placebo | 0.017 | Standard Error 0.005 | Litres | |
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169 | Tiotropium | 0.121 | Standard Error 0.006 | Litres | |
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169 | Placebo | 0.018 | Standard Error 0.006 | Litres | |
| Number of COPD Exacerbations Per Patient - Exposure Adjusted | Tiotropium | 0 | Full Range 0 | COPD exacerbations per year | |
| Number of COPD Exacerbations Per Patient - Exposure Adjusted | Placebo | 0 | Full Range 0 | COPD exacerbations per 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 | 1,989 | |
| Overall Study | STARTED | Placebo | 2,002 | |
| Overall Study | COMPLETED | Tiotropium | 1,671 | |
| Overall Study | COMPLETED | Placebo | 1,629 | |
| Overall Study | NOT COMPLETED | Tiotropium | 318 | |
| Overall Study | NOT COMPLETED | Placebo | 373 |
Source ClinicalTrials.gov
Adverse events718
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 | Nasopharyngitis | Infections and infestations | Tiotropium | 157 | 1,952 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 151 | 1,965 | |
| other | Upper respiratory tract infection | Infections and infestations | Tiotropium | 97 | 1,952 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 123 | 1,965 | |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Tiotropium | 561 | 1,952 | |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Placebo | 659 | 1,965 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Tiotropium | 122 | 1,952 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Placebo | 144 | 1,965 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Tiotropium | 123 | 1,952 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 106 | 1,965 |
1 to 10 of 718Source ClinicalTrials.gov
See all 718 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 | Placebo | ||
| Total, other adverse events | Tiotropium | 866 | 1,952 |
| Total, other adverse events | Placebo | 926 | 1,965 |
| Total, serious adverse events | Tiotropium | 342 | 1,952 |
| Total, serious adverse events | Placebo | 336 | 1,965 |
Source ClinicalTrials.gov
Papers2
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tiotropium vs Placebo: Number of Patients With at Least One Hospitalisation for a COPD Exacerbation | Trial comparisons |
| Tiotropium vs Placebo: Number of Patients With at Least One COPD Exacerbation | Trial comparisons |
| Tiotropium vs Placebo: serious adverse events | 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.
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