40 and older, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Patients With Therapeutic Success After Approximately 6 Weeks.Primary· Approximately 6 weeks
The therapeutic success was defined as a minimum of 10- point increase in the Physical Functioning (PF-10) score between visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1), having approximately time period of 6 weeks between the evaluated questionnaires. PF-10 score measures changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients.
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
67.76
66.67 – 68.84
Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2)Secondary· Baseline and week 6
Change in PF-10 score was determined by taking into account the individual change of each patient between visit 1 and visit 2. The PF-10 used for assessing the primary outcome is a sub-domain of the validated Short Form (SF)-36 quality of life questionnaire and consists of 10 questions evaluating the experienced restrictions while conducting usual activities. Each question of the PF-10 may be answered with "yes, limited a lot", "yes, limited a little", or "No, not limited at all", with a score of 1, 2, or 3, respectively. The scores will be summed up between 10 and 30. The final sum of the ind
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
16.62
± 17.87
General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2).Secondary· Baseline and week 6
This outcome measures general condition of the patient evaluated by the physician (PGE score) at visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1) evaluated on an 8-point scale with the scores "Poor (1,2)", "Satisfactory (3, 4)", "Good (5, 6)" and "Excellent (7, 8)". More the score, the better is the general condition of patient.
Score 1 at visit 1
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
96
Score 2 at visit 1
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
754
Score 3 at visit 1
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
1907
Score 4 at visit 1
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
2159
Score 5 at visit 1
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
1317
Score 6 at visit 1
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
743
Score 7 at visit 1
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
203
Score 8 at visit 1
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
39
Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)Secondary· Approximately 6 weeks
At visit 2 patients were asked for their overall satisfaction with the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.
Very satisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
2847
Satisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
2998
Rather satisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
890
Neither satisfied nor dissatisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
307
Rather dissatisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
93
Dissatisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
52
Very dissatisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
26
Not answered
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
5
Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)Secondary· Approximately 6 weeks
At visit 2 patients were asked how satisfied they were with inhaling from the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.
Very satisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
3143
Satisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
3021
Rather satisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
716
Neither satisfied nor dissatisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
228
Rather dissatisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
48
Dissatisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
34
Very dissatisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
11
Not answered
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
17
Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)Secondary· Approximately 6 weeks
At visit 2 patients were asked how satisfied they were with handling the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.
Very satisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
3086
Satisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
2988
Rather satisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
794
Neither satisfied nor dissatisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
239
Rather dissatisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
55
Dissatisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
30
Very dissatisfied
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
9
Not answered
Group
Value
95% CI
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
17
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose adminstration until 21 days after permanently discontinuation of therapy or end of the study..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
Serious: 5/7443 (0%)
Deaths: 4/7443
Serious adverse events (5 terms)
Reaction
System
Spiolto® Respimat® 2.5 Mic…
Atrial fibrillation
Cardiac disorders
—
Pneumonia
Infections and infestations
—
Sepsis
Infections and infestations
—
Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Real-world data on the effects of a fixed-dose combination Long-acting beta agonists + long-acting antimuscarinic agent (LABA+LAMA) therapy with tiotropium and olodaterol administered in a single device, in COPD patients who need treatment with two long-acting bronchodilators, is not available. This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto Respimat according to the approved Summary of Product Characteristics (SmPC).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 9 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02719639.