Trial Outcomes & Findings for Changes in Physical Functioning in Patients With COPD During Therapy With a Combination Inhalation Therapy (NCT NCT02173769)
NCT ID: NCT02173769
Last Updated: 2017-06-05
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
1845 participants
Primary outcome timeframe
Baseline and 4-6 weeks
Results posted on
2017-06-05
Participant Flow
An open, prospective non-interventional study in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Participant milestones
| Measure |
All Patients
Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
|
|---|---|
|
Overall Study
STARTED
|
1858
|
|
Overall Study
COMPLETED
|
1854
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
All Patients
Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
|
|---|---|
|
Overall Study
Protocol Violation
|
4
|
Baseline Characteristics
Changes in Physical Functioning in Patients With COPD During Therapy With a Combination Inhalation Therapy
Baseline characteristics by cohort
| Measure |
All Patients
n=1858 Participants
Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
|
|---|---|
|
Age, Continuous
|
67.41 Years
STANDARD_DEVIATION 10.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
770 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1088 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4-6 weeksPopulation: Full analysis (FAS) which includes all patients enrolled in the study who did not violated any inclusion or exclusion criteria.
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.
Outcome measures
| Measure |
All Patients
n=1726 Participants
Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
|
|---|---|
|
Percentage of Participants With "Therapeutic Success"
Therapy successful
|
48.90 Percentage of participants
|
|
Percentage of Participants With "Therapeutic Success"
Therapy not successful
|
51.10 Percentage of participants
|
SECONDARY outcome
Timeframe: 4-6 weeksPopulation: FAS
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.
Outcome measures
| Measure |
All Patients
n=1726 Participants
Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
|
|---|---|
|
Absolute Changes in the PF-10 Score
|
10.15 Units on a scale
Standard Deviation 19.22
|
SECONDARY outcome
Timeframe: BaselinePopulation: FAS including patients with available PGE score at 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).
Outcome measures
| Measure |
All Patients
n=1853 Participants
Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
|
|---|---|
|
General Health of the Patient at Baseline
1 (poor)
|
2.10 Percentage of participants
|
|
General Health of the Patient at Baseline
2
|
14.72 Percentage of participants
|
|
General Health of the Patient at Baseline
3
|
25.73 Percentage of participants
|
|
General Health of the Patient at Baseline
4
|
29.13 Percentage of participants
|
|
General Health of the Patient at Baseline
5
|
16.57 Percentage of participants
|
|
General Health of the Patient at Baseline
6
|
9.44 Percentage of participants
|
|
General Health of the Patient at Baseline
7
|
2.16 Percentage of participants
|
|
General Health of the Patient at Baseline
8 (excellent)
|
0.11 Percentage of participants
|
SECONDARY outcome
Timeframe: 4-6 weeksPopulation: FAS including patients with available PGE score at end of study visit
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).
Outcome measures
| Measure |
All Patients
n=1770 Participants
Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
|
|---|---|
|
General Health of the Patient After 4-6 Weeks
1 (poor)
|
0.96 Percentage of participants
|
|
General Health of the Patient After 4-6 Weeks
2
|
5.48 Percentage of participants
|
|
General Health of the Patient After 4-6 Weeks
3
|
13.67 Percentage of participants
|
|
General Health of the Patient After 4-6 Weeks
4
|
22.60 Percentage of participants
|
|
General Health of the Patient After 4-6 Weeks
5
|
25.08 Percentage of participants
|
|
General Health of the Patient After 4-6 Weeks
6
|
22.09 Percentage of participants
|
|
General Health of the Patient After 4-6 Weeks
7
|
8.25 Percentage of participants
|
|
General Health of the Patient After 4-6 Weeks
8 (excellent)
|
1.86 Percentage of participants
|
SECONDARY outcome
Timeframe: 4-6 weeksPopulation: FAS including patients with available satisfaction data
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).
Outcome measures
| Measure |
All Patients
n=1773 Participants
Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
|
|---|---|
|
Patient Satisfaction: Overall Satisfaction
Very satisifed
|
25.21 Percentage of participants
|
|
Patient Satisfaction: Overall Satisfaction
Satisfied
|
42.13 Percentage of participants
|
|
Patient Satisfaction: Overall Satisfaction
Rather satisfied
|
13.53 Percentage of participants
|
|
Patient Satisfaction: Overall Satisfaction
Neither satisfied or dissatisfied
|
9.70 Percentage of participants
|
|
Patient Satisfaction: Overall Satisfaction
Rather dissatisfied
|
4.29 Percentage of participants
|
|
Patient Satisfaction: Overall Satisfaction
Dissatisfied
|
4.06 Percentage of participants
|
|
Patient Satisfaction: Overall Satisfaction
Very dissatisfied
|
1.07 Percentage of participants
|
SECONDARY outcome
Timeframe: 4-6 weeksPopulation: FAS including patients with available inhaler satisfaction data
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).
Outcome measures
| Measure |
All Patients
n=1779 Participants
Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
|
|---|---|
|
Patient Satisfaction: Satisfaction With Inhaler
Very satisifed
|
31.53 Percentage of participants
|
|
Patient Satisfaction: Satisfaction With Inhaler
Satisfied
|
49.86 Percentage of participants
|
|
Patient Satisfaction: Satisfaction With Inhaler
Rather satisfied
|
10.06 Percentage of participants
|
|
Patient Satisfaction: Satisfaction With Inhaler
Neither satisfied or dissatisfied
|
5.12 Percentage of participants
|
|
Patient Satisfaction: Satisfaction With Inhaler
Rather dissatisfied
|
1.52 Percentage of participants
|
|
Patient Satisfaction: Satisfaction With Inhaler
Dissatisfied
|
1.46 Percentage of participants
|
|
Patient Satisfaction: Satisfaction With Inhaler
Very dissatisfied
|
0.45 Percentage of participants
|
SECONDARY outcome
Timeframe: 4-6 weeksPopulation: FAS including patients with available handling of inhaler satisfaction data
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).
Outcome measures
| Measure |
All Patients
n=1778 Participants
Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
|
|---|---|
|
Patient Satisfaction: Satisfaction With Handling of Inhaler
Very satisifed
|
31.44 Percentage of participants
|
|
Patient Satisfaction: Satisfaction With Handling of Inhaler
Satisfied
|
49.32 Percentage of participants
|
|
Patient Satisfaction: Satisfaction With Handling of Inhaler
Rather satisfied
|
11.25 Percentage of participants
|
|
Patient Satisfaction: Satisfaction With Handling of Inhaler
Neither satisfied or dissatisfied
|
5.06 Percentage of participants
|
|
Patient Satisfaction: Satisfaction With Handling of Inhaler
Rather dissatisfied
|
1.57 Percentage of participants
|
|
Patient Satisfaction: Satisfaction With Handling of Inhaler
Dissatisfied
|
0.96 Percentage of participants
|
|
Patient Satisfaction: Satisfaction With Handling of Inhaler
Very dissatisfied
|
0.39 Percentage of participants
|
Adverse Events
Spiriva Respimat + Striverdi Respimat
Serious events: 30 serious events
Other events: 0 other events
Deaths: 0 deaths
Spiriva 18 mcg + Striverdi Respimat
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Spiriva Respimat + Striverdi Respimat
n=1298 participants at risk
Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat
|
Spiriva 18 mcg + Striverdi Respimat
n=560 participants at risk
Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva 18 microgram plus Striverdi Respimat
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.08%
1/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.08%
1/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.08%
1/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.18%
1/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.18%
1/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.15%
2/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.18%
1/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.08%
1/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.08%
1/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
General disorders
Death
|
0.08%
1/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.18%
1/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
General disorders
Sudden cardiac death
|
0.00%
0/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.18%
1/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Infections and infestations
Bronchitis
|
0.15%
2/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Infections and infestations
Bronchopneumonia
|
0.08%
1/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.18%
1/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Infections and infestations
Gingivitis
|
0.08%
1/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.08%
1/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Infections and infestations
Pneumonia
|
0.15%
2/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.18%
1/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.18%
1/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.08%
1/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.15%
2/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.08%
1/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.08%
1/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.62%
8/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.36%
2/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.18%
1/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.18%
1/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.08%
1/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
|
Vascular disorders
Hypertension
|
0.08%
1/1298 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
0.00%
0/560 • From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place