Trial · NCT02850978
Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease
NCT02850978, Completed, Boehringer Ingelheim; results first posted 2019-12-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease. Trials, record NCT02850978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02850978
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease
- NCT number
- NCT02850978
- Status
- Completed
- Enrollment
- 1,335 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Spiolto
- First posted
- 2016-08-01
- Last updated
- 2019-12-06
- Results first posted
- 2019-12-06
- Limitations and caveats
- The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Drug Reactions | From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks. | Percentage of participants with adverse drug reactions (ADR). An adverse drug reaction (ADR) is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Spiolto® Respimat® as "Yes". |
| Secondary | Change of COPD Assessment Test (CAT) Score From Baseline to Week 12 | Baseline and Week 12 | The COPD Assessment Test™ (CAT) is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health). The CAT questionnaire has the advantage of a reduced number of items and could be used to assess the effects of inhaled therapies. The CAT score was the sum of the values corresponding to the answers to the eight questions. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Drug Reactions | From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks. | Safety set: This patient set includes all patients who were documented to have taken at least one dose of Spiolto® Respimat® excluding no visit after Spiolto® Respimat® administration. | Percentage of participants (%) | NUMBER |
| SECONDARY | Change of COPD Assessment Test (CAT) Score From Baseline to Week 12 | Baseline and Week 12 | Effectiveness set: The effectiveness set included all patients in the safety set except for those patients who had no any values of CAT, Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC) after Spiolto® Respimat® administration. | Unit on a scale | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Drug Reactions | Spiolto® | 3.93 | Percentage of participants (%) | ||
| Change of COPD Assessment Test (CAT) Score From Baseline to Week 12 | Spiolto® | -3.7 | Standard Deviation 7.1 | Unit on a scale |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Spiolto® | 1,335 | |
| Overall Study | Case Report Form (CRF) Collected | Spiolto® | 1,308 | |
| Overall Study | Treated | Spiolto® | 1,308 | |
| Overall Study | COMPLETED | Spiolto® | 909 | |
| Overall Study | NOT COMPLETED | Spiolto® | 426 |
Source ClinicalTrials.gov
Adverse events78
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 |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Spiolto® | 2 | 1,273 | |
| serious | Cardiac failure | Cardiac disorders | Spiolto® | 5 | 1,273 | |
| serious | Cardiac failure congestive | Cardiac disorders | Spiolto® | 3 | 1,273 | |
| serious | Cardio-respiratory arrest | Cardiac disorders | Spiolto® | 2 | 1,273 | |
| serious | Acute myocardial infarction | Cardiac disorders | Spiolto® | 1 | 1,273 | |
| serious | Angina pectoris | Cardiac disorders | Spiolto® | 1 | 1,273 | |
| serious | Atrioventricular block second degree | Cardiac disorders | Spiolto® | 1 | 1,273 | |
| serious | Cardiac arrest | Cardiac disorders | Spiolto® | 1 | 1,273 | |
| serious | Cardiac failure acute | Cardiac disorders | Spiolto® | 1 | 1,273 | |
| serious | Cardiac failure chronic | Cardiac disorders | Spiolto® | 1 | 1,273 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Spiolto® | 38 | 1,273 |
| Total, other adverse events | Spiolto® | 0 | 1,273 |
| Total, serious adverse events | Spiolto® | 94 | 1,273 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35948844 | DERIVED |
Source PubMed
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/NCT02850978
GET https://conductscience.org/api/trials/v1/NCT02850978/events?page=2