Trial · NCT02173769
Changes in Physical Functioning in Patients With COPD During Therapy With a Combination Inhalation Therapy
NCT02173769, Completed, Boehringer Ingelheim; results first posted 2016-04-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Changes in Physical Functioning in Patients With COPD During Therapy With a Combination Inhalation Therapy. Trials, record NCT02173769. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02173769
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Changes in Physical Functioning in Patients With COPD During Therapy With a Combination Inhalation Therapy
- NCT number
- NCT02173769
- Status
- Completed
- Enrollment
- 1,845 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Spiriva® Respimat®, Striverdi® Respimat®
- First posted
- 2014-06-25
- Last updated
- 2017-06-05
- Results first posted
- 2016-04-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With "Therapeutic Success" | Baseline and 4-6 weeks | Percentage of participants with "therapeutic success" defined as a 10-point increase in the physical activity assessed by patient´s questionnaire (PF-10) score between the initial examination and after 4-6 weeks. The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning. |
| Secondary | Absolute Changes in the PF-10 Score | 4-6 weeks | Absolute changes in the PF-10 score. The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning. |
| Secondary | General Health of the Patient at Baseline | Baseline | General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score at the initial examination. The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent). |
| Secondary | General Health of the Patient After 4-6 Weeks | 4-6 weeks | General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score after 4-6 weeks. The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent). |
| Secondary | Patient Satisfaction: Overall Satisfaction | 4-6 weeks | Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat. Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7). |
| Secondary | Patient Satisfaction: Satisfaction With Inhaler | 4-6 weeks | Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat. Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7). |
| Secondary | Patient Satisfaction: Satisfaction With Handling of Inhaler | 4-6 weeks | Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat. Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7). |
Source ClinicalTrials.gov
Outcomes7
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 Therapeutic Success | Baseline and 4-6 weeks | Full analysis (FAS) which includes all patients enrolled in the study who did not violated any inclusion or exclusion criteria. | Percentage of participants | NUMBER |
| SECONDARY | Absolute Changes in the PF-10 Score | 4-6 weeks | FAS | Units on a scale | MEAN |
| SECONDARY | General Health of the Patient at Baseline | Baseline | FAS including patients with available PGE score at baseline | Percentage of participants | NUMBER |
| SECONDARY | General Health of the Patient After 4-6 Weeks | 4-6 weeks | FAS including patients with available PGE score at end of study visit | Percentage of participants | NUMBER |
| SECONDARY | Patient Satisfaction: Overall Satisfaction | 4-6 weeks | FAS including patients with available satisfaction data | Percentage of participants | NUMBER |
| SECONDARY | Patient Satisfaction: Satisfaction With Inhaler | 4-6 weeks | FAS including patients with available inhaler satisfaction data | Percentage of participants | NUMBER |
| SECONDARY | Patient Satisfaction: Satisfaction With Handling of Inhaler | 4-6 weeks | FAS including patients with available handling of inhaler satisfaction data | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
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 Therapeutic Success | All Patients | Therapy successful | 48.90 | Percentage of participants | |
| Percentage of Participants With Therapeutic Success | All Patients | Therapy not successful | 51.10 | Percentage of participants | |
| Absolute Changes in the PF-10 Score | All Patients | 10.15 | Standard Deviation 19.22 | Units on a scale | |
| General Health of the Patient at Baseline | All Patients | 1 (poor) | 2.10 | Percentage of participants | |
| General Health of the Patient at Baseline | All Patients | 2 | 14.72 | Percentage of participants | |
| General Health of the Patient at Baseline | All Patients | 3 | 25.73 | Percentage of participants | |
| General Health of the Patient at Baseline | All Patients | 4 | 29.13 | Percentage of participants | |
| General Health of the Patient at Baseline | All Patients | 5 | 16.57 | Percentage of participants | |
| General Health of the Patient at Baseline | All Patients | 6 | 9.44 | Percentage of participants | |
| General Health of the Patient at Baseline | All Patients | 7 | 2.16 | Percentage of participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Patients | 1,858 | |
| Overall Study | COMPLETED | All Patients | 1,854 | |
| Overall Study | NOT COMPLETED | All Patients | 4 |
Source ClinicalTrials.gov
Adverse events54
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 | Spiriva Respimat + Striverdi Respimat | 1 | 1,298 | |
| serious | Anaemia | Blood and lymphatic system disorders | Spiriva 18 mcg + Striverdi Respimat | 0 | 560 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Spiriva Respimat + Striverdi Respimat | 1 | 1,298 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Spiriva 18 mcg + Striverdi Respimat | 0 | 560 | |
| serious | Angina pectoris | Cardiac disorders | Spiriva Respimat + Striverdi Respimat | 1 | 1,298 | |
| serious | Angina pectoris | Cardiac disorders | Spiriva 18 mcg + Striverdi Respimat | 0 | 560 | |
| serious | Atrial flutter | Cardiac disorders | Spiriva Respimat + Striverdi Respimat | 0 | 1,298 | |
| serious | Atrial flutter | Cardiac disorders | Spiriva 18 mcg + Striverdi Respimat | 1 | 560 | |
| serious | Cardiac arrest | Cardiac disorders | Spiriva Respimat + Striverdi Respimat | 0 | 1,298 | |
| serious | Cardiac arrest | Cardiac disorders | Spiriva 18 mcg + Striverdi Respimat | 1 | 560 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Spiriva Respimat + Striverdi Respimat | ||
| Total, all-cause mortality | Spiriva 18 mcg + Striverdi Respimat | ||
| Total, other adverse events | Spiriva Respimat + Striverdi Respimat | 0 | 1,298 |
| Total, other adverse events | Spiriva 18 mcg + Striverdi Respimat | 0 | 560 |
| Total, serious adverse events | Spiriva Respimat + Striverdi Respimat | 30 | 1,298 |
| Total, serious adverse events | Spiriva 18 mcg + Striverdi Respimat | 12 | 560 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Spiriva Respimat + Striverdi Respimat vs Spiriva 18 mcg + Striverdi Respimat: 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/NCT02173769
GET https://conductscience.org/api/trials/v1/NCT02173769/results?page=2