Trial · NCT01126437
Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease
NCT01126437, Phase 3, Completed, Boehringer Ingelheim; results first posted 2014-06-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease. Trials, record NCT01126437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01126437
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease
- NCT number
- NCT01126437
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 17,183 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- tiotropium 18 mcg, tiotropium 1.25 mcg (2 actuations/day), tiotropium 2.5 mcg (2 actuations/day)
- First posted
- 2010-05-19
- Last updated
- 2014-06-20
- Other registries' IDs
- eudract:2009-015713-51
- Results first posted
- 2014-06-20
- Limitations and caveats
Prospectively defined outcome events, serious adverse events, adverse events leading to discontinuation, and investigator-determined drug-related adverse events were required for collection in this trial.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to All-Cause Mortality | Up to 3 years | Number of patients with all-cause mortality |
| Primary | Time to First COPD Exacerbation | Up to 3 years | Defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines). "Onset of exacerbation" was defined by the onset of first recorded symptom. The "end of exacerbation" was decided by the investigator based on clinical judgement. Exacerbations were classified as follows: Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization. |
| Secondary | Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients) | Up to 3 years | Trough forced expiratory volume in one second (FEV1) over 120 weeks (in a substudy of 1370 patients) |
| Secondary | Number of COPD Exacerbations | Up to 3 years | The number of COPD exacerbations. COPD exacerbation defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines). |
| Secondary | Time to First Hospitalization Associated With COPD Exacerbation | Up to 3 years | The results presented below are for the patients with hospitalizations due to COPD exacerbations. |
| Secondary | Number of Hospitalizations Associated With COPD Exacerbation | Up to 3 years | Total number of hospitalizations associated with COPD exacerbation. |
| Secondary | Time to First Moderate to Severe COPD Exacerbation | Up to 3 years | COPD exacerbation defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines). Exacerbations classified as follows: Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization. Results presented below are number of patients with moderate to severe exacerbations. |
| Secondary | Time to Onset of First Major Adverse Cardiovascular Event (MACE) | Up to 3 years | Time to onset of first major adverse cardiovascular event (MACE). MACE was defined as: Fatal event in the system organ classes of cardiac and vascular disorders, Preferred terms: sudden death, cardiac death, sudden cardiac death, Outcome events of myocardial infarction (serious and non-serious), Outcome events of stroke (serious and non-serious) and Outcome events of TIA (serious and non-serious). The results presented below are for the number of patients with MACE. |
| Secondary | Time to Death From Major Adverse Cardiovascular Event (MACE) | Up to 3 years | The results presented below are number of patients with death from MACE. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to All-Cause Mortality | Up to 3 years | Death analysis set (DAS) including vital status follow-up: This analysis set included all randomized subjects excluding only subjects who were documented as not treated. | Number of deaths | NUMBER |
| PRIMARY | Time to First COPD Exacerbation | Up to 3 years | Treated set (TS, on-treatment only) | days to event | MEDIAN |
| SECONDARY | Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients) | Up to 3 years | SSS - PFT - Sub-study set (pulmonary function testing). This analysis set included all subjects in the TS who signed informed consent to participate in the spirometry sub-study and had at least baseline and one on-treatment trough FEV1. | Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Number of COPD Exacerbations | Up to 3 years | Treated Set - on treatment only | number of COPD exacerbations | NUMBER |
| SECONDARY | Time to First Hospitalization Associated With COPD Exacerbation | Up to 3 years | treated set - on-treatment only | Number of patients with event | NUMBER |
| SECONDARY | Number of Hospitalizations Associated With COPD Exacerbation | Up to 3 years | treated set - on treatment only | number of hospitalizations | NUMBER |
| SECONDARY | Time to First Moderate to Severe COPD Exacerbation | Up to 3 years | treated set - on treatment only | number of patients with event | NUMBER |
| SECONDARY | Time to Onset of First Major Adverse Cardiovascular Event (MACE) | Up to 3 years | Treated set - on treatment only | number of patients with MACE | NUMBER |
| SECONDARY | Time to Death From Major Adverse Cardiovascular Event (MACE) | Up to 3 years | TS including vital status follow-up, DAS | Number of deaths from MACE | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to All-Cause Mortality | Tiotropium 2.5 mcg and Placebo | 440 | 7.7 | Number of deaths | |
| Time to All-Cause Mortality | Tiotropium 5 mcg and Placebo | 423 | 7.4 | Number of deaths | |
| Time to All-Cause Mortality | Tiotropium 18 mcg and Placebo | 439 | 7.7 | Number of deaths | |
| Time to First COPD Exacerbation | Tiotropium 2.5 mcg and Placebo | 707 | 95% Confidence Interval 662 to 750 | days to event | |
| Time to First COPD Exacerbation | Tiotropium 5 mcg and Placebo | 756 | 95% Confidence Interval 692 to 816 | days to event | |
| Time to First COPD Exacerbation | Tiotropium 18 mcg and Placebo | 719 | 95% Confidence Interval 672 to 777 | days to event | |
| Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients) | Tiotropium 2.5 mcg and Placebo | 1.258 | Standard Error 0.012 | Liter | |
| Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients) | Tiotropium 5 mcg and Placebo | 1.285 | Standard Error 0.012 | Liter | |
| Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients) | Tiotropium 18 mcg and Placebo | 1.295 | Standard Error 0.012 | Liter | |
| Number of COPD Exacerbations | Tiotropium 2.5 mcg and Placebo | 6565 | number of COPD exacerbations |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tiotropium 2.5 mcg and Placebo | 5,741 | |
| Overall Study | STARTED | Tiotropium 5 mcg and Placebo | 5,729 | |
| Overall Study | STARTED | Tiotropium 18 mcg and Placebo | 5,713 | |
| Overall Study | COMPLETED | Tiotropium 2.5 mcg and Placebo | 4,400 | |
| Overall Study | COMPLETED | Tiotropium 5 mcg and Placebo | 4,399 | |
| Overall Study | COMPLETED | Tiotropium 18 mcg and Placebo | 4,400 | |
| Overall Study | NOT COMPLETED | Tiotropium 2.5 mcg and Placebo | 1,341 | |
| Overall Study | NOT COMPLETED | Tiotropium 5 mcg and Placebo | 1,330 | |
| Overall Study | NOT COMPLETED | Tiotropium 18 mcg and Placebo | 1,313 |
Source ClinicalTrials.gov
Adverse events3,723
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 2.5 mcg and Placebo | 1,932 | 5,724 | |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Tiotropium 5 mcg and Placebo | 1,876 | 5,705 | |
| other | Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Tiotropium 18 mcg and Placebo | 1,928 | 5,687 | |
| serious | Anaemia | Blood and lymphatic system disorders | Tiotropium 2.5 mcg and Placebo | 10 | 5,724 | |
| serious | Anaemia | Blood and lymphatic system disorders | Tiotropium 5 mcg and Placebo | 10 | 5,705 | |
| serious | Anaemia | Blood and lymphatic system disorders | Tiotropium 18 mcg and Placebo | 13 | 5,687 | |
| serious | Coagulopathy | Blood and lymphatic system disorders | Tiotropium 2.5 mcg and Placebo | 0 | 5,724 | |
| serious | Coagulopathy | Blood and lymphatic system disorders | Tiotropium 5 mcg and Placebo | 0 | 5,705 | |
| serious | Coagulopathy | Blood and lymphatic system disorders | Tiotropium 18 mcg and Placebo | 3 | 5,687 | |
| serious | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Tiotropium 2.5 mcg and Placebo | 1 | 5,724 |
1 to 10 of 3,723Source ClinicalTrials.gov
See all 3,723 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tiotropium 2.5 mcg and Placebo | ||
| Total, all-cause mortality | Tiotropium 5 mcg and Placebo | ||
| Total, all-cause mortality | Tiotropium 18 mcg and Placebo | ||
| Total, other adverse events | Tiotropium 2.5 mcg and Placebo | 1,932 | 5,724 |
| Total, other adverse events | Tiotropium 5 mcg and Placebo | 1,876 | 5,705 |
| Total, other adverse events | Tiotropium 18 mcg and Placebo | 1,928 | 5,687 |
| Total, serious adverse events | Tiotropium 2.5 mcg and Placebo | 1,932 | 5,724 |
| Total, serious adverse events | Tiotropium 5 mcg and Placebo | 1,876 | 5,705 |
| Total, serious adverse events | Tiotropium 18 mcg and Placebo | 1,928 | 5,687 |
Source ClinicalTrials.gov
Papers5
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01126437
GET https://conductscience.org/api/trials/v1/NCT01126437/results?page=2