Trial Outcomes & Findings for Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease During Therapy With Spiolto® Respimat® (AERIAL®) (NCT NCT03165045)
NCT ID: NCT03165045
Last Updated: 2020-04-09
Results Overview
The primary endpoint of the study was "therapeutic success" at 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. 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. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4.
COMPLETED
1351 participants
Final visit at the end of the study, approximately 6 weeks after start of study
2020-04-09
Participant Flow
Chronic obstructive pulmonary disease patients receiving treatment with Spiolto® Respimat® for approximately 6 weeks in routine clinical practice
All subjects were screened for eligibility to participate in trial. Subjects attended specialist site to ensure that they (the subjects) met all implemented inclusion/exclusion criteria.
Participant milestones
| Measure |
Spiolto® Respimat®
Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution Baseline visit at the start of the study
|
|---|---|
|
Visit 1
STARTED
|
1351
|
|
Visit 1
COMPLETED
|
1322
|
|
Visit 1
NOT COMPLETED
|
29
|
|
Visit 2
STARTED
|
1322
|
|
Visit 2
COMPLETED
|
1140
|
|
Visit 2
NOT COMPLETED
|
182
|
Reasons for withdrawal
| Measure |
Spiolto® Respimat®
Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution Baseline visit at the start of the study
|
|---|---|
|
Visit 1
No registration after visit 1
|
9
|
|
Visit 1
No treatment documented
|
10
|
|
Visit 1
No visit 1
|
10
|
|
Visit 2
Available CCQ score at visit 1 only
|
109
|
|
Visit 2
No available total CCQ score at all
|
29
|
|
Visit 2
Available total CCQ score at vist 2 only
|
44
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Spiolto® Respimat® at Study Start
n=1322 Participants
Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution Baseline visit at the start of the study
|
|---|---|
|
Age, Continuous
|
65.63 Years
STANDARD_DEVIATION 10.09 • n=1322 Participants
|
|
Sex: Female, Male
Female
|
562 Participants
n=1322 Participants
|
|
Sex: Female, Male
Male
|
760 Participants
n=1322 Participants
|
|
CCQ Score
Symptom (Items: 1; 2; 5; 6)
|
3.42 Score
STANDARD_DEVIATION 1.13 • n=1140 Participants • CCQ at baseline is measured for patients with an observation of the score for visit 1 and visit 2.
|
|
CCQ Score
Functional state (CCQ-4) (Items: 7-10)
|
3.05 Score
STANDARD_DEVIATION 1.24 • n=1140 Participants • CCQ at baseline is measured for patients with an observation of the score for visit 1 and visit 2.
|
|
CCQ Score
Mental state (Items: 3; 4)
|
2.69 Score
STANDARD_DEVIATION 1.58 • n=1140 Participants • CCQ at baseline is measured for patients with an observation of the score for visit 1 and visit 2.
|
|
CCQ Score
Total CCQ score (All subscales)
|
3.12 Score
STANDARD_DEVIATION 1.09 • n=1140 Participants • CCQ at baseline is measured for patients with an observation of the score for visit 1 and visit 2.
|
PRIMARY outcome
Timeframe: Final visit at the end of the study, approximately 6 weeks after start of studyPopulation: All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS).
The primary endpoint of the study was "therapeutic success" at 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. 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. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4.
Outcome measures
| Measure |
Spiolto® Respimat
n=1140 Participants
Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution
|
Spiolto® Respimat® Final Vist
Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution
|
|---|---|---|
|
Therapeutic Success
Therapy successfull
|
756 Participants
|
—
|
SECONDARY outcome
Timeframe: Final visit at the end of the study, approximately 6 weeks after start of studyPopulation: All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS).
Absolute changes in total CCQ score and CCQ-4 score from baseline visit at the start of the study to final visit at the end of study. The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. 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. A change of 0.4 points is was considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4.
Outcome measures
| Measure |
Spiolto® Respimat
n=1140 Participants
Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution
|
Spiolto® Respimat® Final Vist
Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution
|
|---|---|---|
|
Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2
Symptom
|
0.84 Percentage of patients (%)
Standard Deviation 1.06
|
—
|
|
Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2
Functional State (CCQ-4)
|
0.75 Percentage of patients (%)
Standard Deviation 1.05
|
—
|
|
Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2
Mental state
|
0.73 Percentage of patients (%)
Standard Deviation 1.34
|
—
|
|
Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2
Total CCQ Score
|
0.78 Percentage of patients (%)
Standard Deviation 0.95
|
—
|
SECONDARY outcome
Timeframe: Baseline visit (Visit 1) at the start of the study and final visit at the end of the study (visit 2), approximately 6 weeks after visit 1Population: All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS).
General condition of the patient, evaluated by the physician (Physician's global Evaluation score) at visit 1 and visit 2. The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent). The modified Medical Research Council (mMRC) scale was used to assess the breathlessness state of the patient before the treatment.
Outcome measures
| Measure |
Spiolto® Respimat
n=1140 Participants
Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution
|
Spiolto® Respimat® Final Vist
n=1140 Participants
Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution
|
|---|---|---|
|
General Condition of the Patient
Score 1
|
11 Participants
|
1 Participants
|
|
General Condition of the Patient
Score 2
|
93 Participants
|
23 Participants
|
|
General Condition of the Patient
Score 3
|
281 Participants
|
95 Participants
|
|
General Condition of the Patient
Score 4
|
378 Participants
|
223 Participants
|
|
General Condition of the Patient
Score 5
|
195 Participants
|
350 Participants
|
|
General Condition of the Patient
Score 6
|
138 Participants
|
325 Participants
|
|
General Condition of the Patient
Score 7
|
43 Participants
|
102 Participants
|
|
General Condition of the Patient
Score 8
|
1 Participants
|
20 Participants
|
|
General Condition of the Patient
Missing
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS).
A patient satisfaction survey was performed at visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. The 7-item satisfaction scale is a self-designed Boehringer-Ingelheim scale, without a public source or validation status.
Outcome measures
| Measure |
Spiolto® Respimat
n=1140 Participants
Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution
|
Spiolto® Respimat® Final Vist
Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution
|
|---|---|---|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient overall satisfaction · Very satisfied
|
427 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient overall satisfaction · Satisfied
|
544 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient overall satisfaction · Rather satisfied
|
95 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient overall satisfaction · Neither satisfied nor dissatisfied
|
46 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient overall satisfaction · Rather dissatisfied
|
13 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient overall satisfaction · Dissatisfied
|
12 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient overall satisfaction · Very dissatisfied
|
3 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient satisfaction with inhaling · Very satisfied
|
429 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient satisfaction with inhaling · Satisfied
|
579 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient satisfaction with inhaling · Rather satisfied
|
85 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient satisfaction with inhaling · Neither satisfied nor dissatisfied
|
33 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient satisfaction with inhaling · Rather dissatisfied
|
8 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient satisfaction with inhaling · Dissatisfied
|
4 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient satisfaction with inhaling · Very dissatisfied
|
2 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient satisfaction with handling · Very satisfied
|
389 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient satisfaction with handling · Satisfied
|
590 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient satisfaction with handling · Rather satisfied
|
116 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient satisfaction with handling · Neither satisfied nor dissatisfied
|
24 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient satisfaction with handling · Rather dissatisfied
|
16 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient satisfaction with handling · Dissatisfied
|
4 Participants
|
—
|
|
Patient Satisfaction With Spiolto® Respimat® at Visit 2
Patient satisfaction with handling · Very dissatisfied
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Patients with a performed visit 2
To assess the willingness to continue treatment with Spiolto® Respimat® at visit 2 patients were asked a yes/no question if they would continue the treatment.
Outcome measures
| Measure |
Spiolto® Respimat
n=1254 Participants
Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution
|
Spiolto® Respimat® Final Vist
Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution
|
|---|---|---|
|
Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2
|
1194 Participants
|
—
|
Adverse Events
Total
Serious adverse events
| Measure |
Total
n=1322 participants at risk
Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.08%
1/1322 • approximated up to 6 weeks after visit 1
|
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