Trial Outcomes & Findings for Greek NIS Spiolto ELLACTO (NCT NCT03419962)
NCT ID: NCT03419962
Last Updated: 2020-04-27
Results Overview
Therapeutic success was defined as ≥0.4 point decrease in the Clinical COPD Questionnaire (CCQ) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score. A higher CCQ score is indicative of worse status. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for CCQ score.
COMPLETED
1360 participants
Between visit 1 (baseline visit at study start) and visit 2 (final visit after end of study, approximately 6 weeks after visit 1).
2020-04-27
Participant Flow
This was an open-label observational study to measure the effectiveness of 6 weeks treatment of Spiolto® Respimat® in Patients with Chronic Obstructive Pulmonary Disease (COPD). The Clinical COPD Questionnaire (CCQ)-score was used to evaluate changes in health and functional status.
All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion and non of the exclusion criteria. 1 enrolled participant was excluded as he/she did not have at least one documented administration of Spiolto® Respimat®.
Participant milestones
| Measure |
Spiolto® Respimat® 2.5mg/2.5mg
2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
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|---|---|
|
Overall Study
STARTED
|
1359
|
|
Overall Study
COMPLETED
|
1322
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Spiolto® Respimat® 2.5mg/2.5mg
2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
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|---|---|
|
Overall Study
Change to other medication
|
1
|
|
Overall Study
Refusal of continuing with trial drug
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Difficulty in inhaling the doses
|
1
|
|
Overall Study
Missing completion data
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31
|
Baseline Characteristics
Treated Set (TS): Treated Set included all screened patients with the informed consent, date of registration and at least one documented administration of Spiolto® Respimat®.
Baseline characteristics by cohort
| Measure |
Spiolto® Respimat® 2.5mg/2.5mg
n=1359 Participants
2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
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|---|---|
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Age, Continuous
|
68.1 Years
STANDARD_DEVIATION 10.17 • n=1359 Participants • Treated Set (TS): Treated Set included all screened patients with the informed consent, date of registration and at least one documented administration of Spiolto® Respimat®.
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|
Sex: Female, Male
Female
|
437 Participants
n=1359 Participants • Treated Set: Treated Set included all screened patients with the informed consent, date of registration and at least one documented administration of Spiolto® Respimat®.
|
|
Sex: Female, Male
Male
|
922 Participants
n=1359 Participants • Treated Set: Treated Set included all screened patients with the informed consent, date of registration and at least one documented administration of Spiolto® Respimat®.
|
PRIMARY outcome
Timeframe: Between visit 1 (baseline visit at study start) and visit 2 (final visit after end of study, approximately 6 weeks after visit 1).Population: Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2.
Therapeutic success was defined as ≥0.4 point decrease in the Clinical COPD Questionnaire (CCQ) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score. A higher CCQ score is indicative of worse status. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for CCQ score.
Outcome measures
| Measure |
Spiolto® Respimat® 2.5mg/2.5mg
n=1332 Participants
2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
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|---|---|
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Percentage of Patients Achieving "Therapeutic Success" Defined as a ≥ 0.4 Point of Decrease in the Clinical COPD Questionnaire (CCQ) Score
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64.3 Percentage of participants
Interval 62.0 to 67.0
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SECONDARY outcome
Timeframe: At visit 1 (baseline visit at study start) and at visit 2 (final visit at end of study, approximately 6 weeks after visit 1).Population: Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2.
Absolute change in Clinical COPD Questionaire (QQC) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6. The sum of the scores divided by 10 gives the CCQ score which measured the health and functional status. A higher CCQ score is indicative of worse status.
Outcome measures
| Measure |
Spiolto® Respimat® 2.5mg/2.5mg
n=1332 Participants
2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
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|---|---|
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Absolute Change in Clinical COPD Questionnaire (CCQ) Score Between Visit 1 and Visit 2
|
-0.63 CCQ-score
Standard Deviation 0.635
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SECONDARY outcome
Timeframe: At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1).Population: Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2.
Absolute change in the functional status subdomain of Clinical COPD Questionnaire (CCQ-4) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ-4 score is a subdomain of the CCQ-score. It contains 4 questions about the functional status of patients. Each questions was scored by the patient on a 7-point scale, (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The QQC-4 score was calculated by the sum of 4 questions divided by 4. A higher CCQ-4 score was indicative of worse status.
Outcome measures
| Measure |
Spiolto® Respimat® 2.5mg/2.5mg
n=1332 Participants
2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
|
|---|---|
|
Absolute Change in the Functional Status Subdomain of Clinical COPD Questionnaire (CCQ-4) Score Between Visit 1 and Visit 2
|
-0.59 CCQ-4 score
Standard Deviation 0.714
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SECONDARY outcome
Timeframe: At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1).Population: Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2.
General condition of the patient, evaluated by Physician´s Global Evaluation (PGE) score at visit 1 and visit 2. The PGE score uses a eight-point ordinal scale, ranging from poor (1,2) to excellent (7,8).
Outcome measures
| Measure |
Spiolto® Respimat® 2.5mg/2.5mg
n=1332 Participants
2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
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|---|---|
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General Condition of Patient at Visit 1 and Visit 2
Visit 1 · Poor (1-2)
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153 Participants
|
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General Condition of Patient at Visit 1 and Visit 2
Visit 1 · Satisfactory (3-4)
|
496 Participants
|
|
General Condition of Patient at Visit 1 and Visit 2
Visit 1 · Good (5-6)
|
568 Participants
|
|
General Condition of Patient at Visit 1 and Visit 2
Visit 1 · Excellent (7-8)
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115 Participants
|
|
General Condition of Patient at Visit 1 and Visit 2
Visit 1 · Missing (Not Done)
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0 Participants
|
|
General Condition of Patient at Visit 1 and Visit 2
Visit 2 · Poor (1-2)
|
38 Participants
|
|
General Condition of Patient at Visit 1 and Visit 2
Visit 2 · Satisfactory (3-4)
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260 Participants
|
|
General Condition of Patient at Visit 1 and Visit 2
Visit 2 · Good (5-6)
|
709 Participants
|
|
General Condition of Patient at Visit 1 and Visit 2
Visit 2 · Excellent (7-8)
|
323 Participants
|
|
General Condition of Patient at Visit 1 and Visit 2
Visit 2 · Missing (Not Done)
|
2 Participants
|
SECONDARY outcome
Timeframe: At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).Population: Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2. Only 1330 patients completed the PASAPQ Part1+Part2.
The patients satisfaction with Respimat was assessed at end of study (visit 2) by the Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 1. PASAPQ Part 1 uses a 7-point ordinal scale, ranging from very dissatisfied to very satisfied, to rate the satisfaction with inhaler attributes. The patients were requested to describe their satisfaction level answering three questions.
Outcome measures
| Measure |
Spiolto® Respimat® 2.5mg/2.5mg
n=1332 Participants
2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
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|---|---|
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Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with feeling of inhaled dose · Somewhat satisfied
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184 Participants
|
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Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with reliability of inhaler · Somewhat satisfied
|
190 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with reliability of inhaler · Satisfied
|
647 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with ease of inhaling · Very satisfied
|
458 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with ease of inhaling · Missing
|
1 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with feeling of inhaled dose · Very dissatisfied
|
2 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with feeling of inhaled dose · Dissatisfied
|
7 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with feeling of inhaled dose · Somewhat dissatisfied
|
7 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with feeling of inhaled dose · Neither satisfied nor dissatisfied
|
99 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with feeling of inhaled dose · Satisfied
|
600 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with feeling of inhaled dose · Very satisfied
|
432 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with feeling of inhaled dose · Missing
|
1 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with reliability of inhaler · Very dissatisfied
|
4 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with reliability of inhaler · Dissatisfied
|
0 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with reliability of inhaler · Somewhat dissatisfied
|
13 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with reliability of inhaler · Neither satisfied nor dissatisfied
|
71 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with reliability of inhaler · Very satisfied
|
406 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with reliability of inhaler · Missing
|
1 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with ease of inhaling · Very dissatisfied
|
3 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with ease of inhaling · Dissatisfied
|
6 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with ease of inhaling · Somewhat dissatisfied
|
8 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with ease of inhaling · Neither satisfied nor dissatisfied
|
67 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with ease of inhaling · Somewhat satisfied
|
175 Participants
|
|
Patients Satisfaction With Spiolto® Respimat® at Visit 2
Satisfaction with ease of inhaling · Satisfied
|
614 Participants
|
SECONDARY outcome
Timeframe: At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit)Population: Only patients from the Full Analysis Set (FAS), who have used Spiriva HandiHaler (HH) prior to the study.
Patients preference for Respimat® Inhaler vs. Spiriva HandiHaler (HH) was assessed using the abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 2 survey. Patients were requested to describe their preference for each inhaler device by answering 2 additional questions.
Outcome measures
| Measure |
Spiolto® Respimat® 2.5mg/2.5mg
n=254 Participants
2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
|
|---|---|
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Patients Preference for Spiolto® Respimat® at Visit 2
Preference for Spiriva HH
|
17 Participants
|
|
Patients Preference for Spiolto® Respimat® at Visit 2
Preference for Spiolto Respimat
|
217 Participants
|
|
Patients Preference for Spiolto® Respimat® at Visit 2
No preference
|
20 Participants
|
SECONDARY outcome
Timeframe: At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).Population: Only patients from the Full Analysis Set (FAS), who have used Spiriva HandiHaler (HH) prior to the study. Only 253 patients were analyzed, as one patient did not answer the question.
Patients' reported willingness to continue using either of the inhalers was measured with a scale score ranking from 0 to 100. 0 indicates not willing to continue using this inhaler and 100 indicates definitely willing to continue using it.
Outcome measures
| Measure |
Spiolto® Respimat® 2.5mg/2.5mg
n=253 Participants
2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
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|---|---|
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Patient's Willingness to Continue Treatment With Spiolto® Respimat® at Visit 2
Scoring of Spiriva HH
|
32.3 Scores on scale
Standard Deviation 27.06
|
|
Patient's Willingness to Continue Treatment With Spiolto® Respimat® at Visit 2
Scoring of Spiolto® Respimat®
|
79.8 Scores on scale
Standard Deviation 21.19
|
Adverse Events
Spiolto® Respimat® 2.5mg/2.5mg
Serious adverse events
| Measure |
Spiolto® Respimat® 2.5mg/2.5mg
n=1359 participants at risk
2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD).
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.07%
1/1359 • From study start until end of study, up to 6 weeks.
Adverse Events were reported for the Treated Set (TS). TS included all screened patients with the informed consent, date of registration and at least one documented administration of Spiolto® Respimat®.
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Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place