Trial Outcomes & Findings for A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler (NCT NCT03663569)
NCT ID: NCT03663569
Last Updated: 2025-01-07
Results Overview
Therapeutic success of Spiolto® Respimat® treatment was defined as 0.4 point decrease in the Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire - Clinical COPD Questionnaire (CCQ) score from visit 1 to visit 2. Each of the 10 CCQ questions is scored by the patient on a 7-point scale between 0 (Never/Not limited at all) and 6 (Almost all the time/Totally limited or unable to do) at baseline (Visit 1) and at the end of the observation after approximately 6 weeks (Visit 2). The sum of the scores divided by 10 gives the CCQ score, which measures the health and functional status. A higher CCQ score is indicative of worse status.
COMPLETED
4819 participants
At Visit 2 (6 weeks after baseline visit 1)
2025-01-07
Participant Flow
This open-label self-controlled observational study over an observational period of 6 weeks (2 visits) was to investigate the potential changes in clinical control of Chronic Obstructive Pulmonary Disease (COPD) patients measured by the Clinical COPD Questionnaire (CCQ) during treatment with Spiolto® Respimat® in routine practice.
All patients were screened for eligibility prior to participation in the trial. Patients attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Participant milestones
| Measure |
Spiolto® Respimat®
Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
|
|---|---|
|
Overall Study
STARTED
|
4819
|
|
Overall Study
COMPLETED
|
4756
|
|
Overall Study
NOT COMPLETED
|
63
|
Reasons for withdrawal
| Measure |
Spiolto® Respimat®
Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
|
|---|---|
|
Overall Study
Discontinuation of study
|
11
|
|
Overall Study
Never taken Spiolto® Respimat®
|
1
|
|
Overall Study
Deceased patient
|
6
|
|
Overall Study
Lost to Follow-up
|
18
|
|
Overall Study
Withdrawal of consent
|
5
|
|
Overall Study
Patient's request
|
11
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Not come to second visit
|
3
|
|
Overall Study
Not meet inclusion / exclusion criterion
|
3
|
|
Overall Study
Serious adverse event
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Spiolto® Respimat®
n=4819 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
|
|---|---|
|
Age, Continuous
|
65.38 Years
STANDARD_DEVIATION 9.34 • n=4819 Participants
|
|
Sex: Female, Male
Female
|
1459 Participants
n=4819 Participants
|
|
Sex: Female, Male
Male
|
3360 Participants
n=4819 Participants
|
PRIMARY outcome
Timeframe: At Visit 2 (6 weeks after baseline visit 1)Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
Therapeutic success of Spiolto® Respimat® treatment was defined as 0.4 point decrease in the Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire - Clinical COPD Questionnaire (CCQ) score from visit 1 to visit 2. Each of the 10 CCQ questions is scored by the patient on a 7-point scale between 0 (Never/Not limited at all) and 6 (Almost all the time/Totally limited or unable to do) at baseline (Visit 1) and at the end of the observation after approximately 6 weeks (Visit 2). The sum of the scores divided by 10 gives the CCQ score, which measures the health and functional status. A higher CCQ score is indicative of worse status.
Outcome measures
| Measure |
Spiolto® Respimat®
n=4700 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
|
|---|---|
|
Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2
|
81.38 Percentage of participants
Interval 80.24 to 82.49
|
SECONDARY outcome
Timeframe: At baseline visit 1 and 6 weeks thereafter at visit 2Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
The CCQ questionnaire 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 at baseline and at the end of observation after approximately 6 weeks. Symptom domain covered 4 questions (number 1, 2, 5, 6), Functional state domain covered 4 questions (number 7, 8, 9, 10), and Mental state domain covered 2 questions (number 3, 4). Scores for the questions in each domain were summed up and divided by the number of questions in each domain giving the resulting score for respective domain. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. Change of the score was calculated as visit 2 minus visit 1.
Outcome measures
| Measure |
Spiolto® Respimat®
n=4700 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
|
|---|---|
|
Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2
Symptom
|
1.09 Score on a scale
Standard Deviation 0.97
|
|
Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2
Functional state
|
0.94 Score on a scale
Standard Deviation 0.96
|
|
Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2
Mental state
|
1.04 Score on a scale
Standard Deviation 1.21
|
|
Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2
Total CCQ score
|
1.02 Score on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: At visit 1Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).
Outcome measures
| Measure |
Spiolto® Respimat®
n=4700 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
|
|---|---|
|
Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)
PGE score = 1
|
44 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)
PGE score = 2
|
471 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)
PGE score = 3
|
1176 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)
PGE score = 4
|
1428 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)
PGE score = 5
|
888 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)
PGE score = 6
|
539 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)
PGE score = 7
|
140 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)
PGE score = 8
|
14 Participants
|
SECONDARY outcome
Timeframe: At visit 2 (6 weeks after baseline visit 1)Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).
Outcome measures
| Measure |
Spiolto® Respimat®
n=4700 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
|
|---|---|
|
Physician's Global Evaluation (PGE) Score at Visit 2
PGE score = 1
|
3 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 2
PGE score = 2
|
45 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 2
PGE score = 3
|
212 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 2
PGE score = 4
|
661 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 2
PGE score = 5
|
1227 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 2
PGE score = 6
|
1468 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 2
PGE score = 7
|
891 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 2
PGE score = 8
|
192 Participants
|
|
Physician's Global Evaluation (PGE) Score at Visit 2
Missing
|
1 Participants
|
SECONDARY outcome
Timeframe: At visit 2 (6 weeks after baseline visit 1)Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
Patient overall satisfaction with Spiolto® Respimat® treatment at visit 2 was reported.
Outcome measures
| Measure |
Spiolto® Respimat®
n=4700 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
|
|---|---|
|
Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2
Very dissatisfied
|
20 Participants
|
|
Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2
Very satisfied
|
1474 Participants
|
|
Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2
Satisfied
|
2055 Participants
|
|
Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2
Rather satisfied
|
803 Participants
|
|
Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2
Neither satisfied nor dissatisfied
|
236 Participants
|
|
Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2
Rather dissatisfied
|
64 Participants
|
|
Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2
Dissatisfied
|
44 Participants
|
|
Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2
Not answered
|
4 Participants
|
SECONDARY outcome
Timeframe: At visit 2 (6 weeks after baseline visit 1)Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
Patient satisfaction with inhaling from the Respimat® device at visit 2 was reported
Outcome measures
| Measure |
Spiolto® Respimat®
n=4700 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
|
|---|---|
|
Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2
Very satisfied
|
1579 Participants
|
|
Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2
Satisfied
|
2119 Participants
|
|
Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2
Rather satisfied
|
694 Participants
|
|
Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2
Neither satisfied nor dissatisfied
|
211 Participants
|
|
Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2
Rather dissatisfied
|
49 Participants
|
|
Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2
Dissatisfied
|
30 Participants
|
|
Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2
Very dissatisfied
|
10 Participants
|
|
Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2
Not answered
|
8 Participants
|
SECONDARY outcome
Timeframe: At visit 2 (6 weeks after baseline visit 1)Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
Patient satisfaction with handling of the Respimat® inhalation device at visit 2 was reported.
Outcome measures
| Measure |
Spiolto® Respimat®
n=4700 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
|
|---|---|
|
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2
Very satisfied
|
1554 Participants
|
|
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2
Satisfied
|
2083 Participants
|
|
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2
Rather satisfied
|
711 Participants
|
|
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2
Neither satisfied nor dissatisfied
|
244 Participants
|
|
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2
Rather dissatisfied
|
60 Participants
|
|
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2
Dissatisfied
|
31 Participants
|
|
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2
Very dissatisfied
|
11 Participants
|
|
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2
Not answered
|
6 Participants
|
SECONDARY outcome
Timeframe: At visit 2 (6 weeks after baseline visit 1)Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
Number of participants willing to continue treatment with Spiolto® Respimat® at visit 2 was reported.
Outcome measures
| Measure |
Spiolto® Respimat®
n=4700 Participants
Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
|
|---|---|
|
Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2
Yes
|
4539 Participants
|
|
Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2
No
|
161 Participants
|
Adverse Events
Spiolto® Respimat®
Serious adverse events
| Measure |
Spiolto® Respimat®
n=4819 participants at risk
Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks.
|
|---|---|
|
Infections and infestations
Sepsis
|
0.02%
1/4819 • From start of treatment until end of observation or discontinuation of treatment, whichever occurred first, up to 29 weeks.
Treated set (TS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), and at least one documented administration of Spiolto® Respimat®.
|
|
Infections and infestations
Septic shock
|
0.02%
1/4819 • From start of treatment until end of observation or discontinuation of treatment, whichever occurred first, up to 29 weeks.
Treated set (TS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), and at least one documented administration of Spiolto® Respimat®.
|
|
Nervous system disorders
Loss of consciousness
|
0.02%
1/4819 • From start of treatment until end of observation or discontinuation of treatment, whichever occurred first, up to 29 weeks.
Treated set (TS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), and at least one documented administration of Spiolto® Respimat®.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.02%
1/4819 • From start of treatment until end of observation or discontinuation of treatment, whichever occurred first, up to 29 weeks.
Treated set (TS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), and at least one documented administration of Spiolto® Respimat®.
|
|
General disorders
Death
|
0.06%
3/4819 • From start of treatment until end of observation or discontinuation of treatment, whichever occurred first, up to 29 weeks.
Treated set (TS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), and at least one documented administration of Spiolto® Respimat®.
|
|
General disorders
Sudden death
|
0.02%
1/4819 • From start of treatment until end of observation or discontinuation of treatment, whichever occurred first, up to 29 weeks.
Treated set (TS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), and at least one documented administration of Spiolto® Respimat®.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER