Trial Outcomes & Findings for Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients (NCT NCT02853123)
NCT ID: NCT02853123
Last Updated: 2019-09-27
Results Overview
At 3 min or end of exercise (if 3 min not achieved), patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). The modified Borg scale is 10-point subjective scoring system, in which a patient rates effort of exertion while performing a particular activity. The scale is 0 to 10, the higher the score, the greater the perceived difficulty. Measure type is actually Adjusted Mean Change from Baseline.
COMPLETED
PHASE4
106 participants
Baseline and week 6
2019-09-27
Participant Flow
This was a randomised, double-blind, active-controlled, 2-period crossover, Phase IV study to evaluate the effects of once daily administration of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on the intensity of breathlessness in patients with Chronic Obstructive Pulmonary Disease (COPD).
All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which then ensured that all patients met all inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any specific entry criteria were violated.
Participant milestones
| Measure |
(Tiotropium 5 Microgram (μg))/(Tiotropium + Olodaterol 5/5 μg)
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks in period 1 followed by a 3 week washout period. In period 2, patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
(Tiotropium + Olodaterol 5/5 μg)/(Tiotropium 5 μg)
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks in period 1 followed by a 3 week washout period. In period 2, patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
52
|
54
|
|
Treatment Period 1
COMPLETED
|
52
|
51
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
3
|
|
Washout Period
STARTED
|
52
|
51
|
|
Washout Period
COMPLETED
|
51
|
48
|
|
Washout Period
NOT COMPLETED
|
1
|
3
|
|
Treatment Period 2
STARTED
|
51
|
48
|
|
Treatment Period 2
COMPLETED
|
51
|
48
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
(Tiotropium 5 Microgram (μg))/(Tiotropium + Olodaterol 5/5 μg)
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks in period 1 followed by a 3 week washout period. In period 2, patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
(Tiotropium + Olodaterol 5/5 μg)/(Tiotropium 5 μg)
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks in period 1 followed by a 3 week washout period. In period 2, patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
|---|---|---|
|
Treatment Period 1
Adverse Event
|
0
|
3
|
|
Washout Period
Worsening of COPD
|
0
|
3
|
|
Washout Period
Adverse Event
|
1
|
0
|
Baseline Characteristics
TS
Baseline characteristics by cohort
| Measure |
Total Subjects
n=106 Participants
This patient set was nested within the randomized set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.
|
|---|---|
|
Age, Continuous
|
63.6 Years
STANDARD_DEVIATION 7.2 • n=5 Participants • TS
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants • TS
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants • TS
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • TS
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants • TS
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • TS
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • TS
|
|
Race (NIH/OMB)
White
|
105 Participants
n=5 Participants • TS
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • TS
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • TS
|
PRIMARY outcome
Timeframe: Baseline and week 6Population: Full analysis set (FAS): This patient set was nested within the treated set (TS) and included patients who had baseline measurement and at least one post-baseline measurement for the primary endpoint. FAS including participants with available data for change from baseline in intensity of breathlessness after 6 weeks of treatment.
At 3 min or end of exercise (if 3 min not achieved), patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). The modified Borg scale is 10-point subjective scoring system, in which a patient rates effort of exertion while performing a particular activity. The scale is 0 to 10, the higher the score, the greater the perceived difficulty. Measure type is actually Adjusted Mean Change from Baseline.
Outcome measures
| Measure |
Tiotropium 5 Microgram (μg)
n=100 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=101 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
|---|---|---|
|
Change From Baseline in Intensity of Breathlessness Measured Using the Modified Borg Scale at the End of the 3 Minute (Min) Constant Speed Shuttle Test After 6 Weeks of Treatment.
|
-0.968 Unit on Scale
Standard Error 0.137
|
-1.325 Unit on Scale
Standard Error 0.136
|
SECONDARY outcome
Timeframe: Baseline and week 6Population: FAS including participants with available data for change from baseline for inspiratory capacity measured prior to exercise after 6 weeks of treatment.
Inspiratory Capacity (IC) is a standard measurement for the assessment of lung function. IC measurements were performed prior to the 3min Constant Speed Shuttle Test (CSST) (at rest). Measure type is actually Adjusted Mean Change from Baseline.
Outcome measures
| Measure |
Tiotropium 5 Microgram (μg)
n=100 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=101 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
|---|---|---|
|
Change From Baseline After 6 Weeks of Treatment for Inspiratory Capacity Measured Prior to Exercise
|
0.279 Litre (L)
Standard Error 0.040
|
0.464 Litre (L)
Standard Error 0.039
|
SECONDARY outcome
Timeframe: Baseline and week 6Population: FAS including participants with available data for change from baseline for inspiratory capacity measured end of exercise after 6 weeks of treatment.
Inspiratory Capacity (IC) is a standard measurement for the assessment of lung function. IC measurements were performed at the end of the 3min Constant Speed Shuttle Test (CSST). Measure type is actually Adjusted Mean Change from Baseline.
Outcome measures
| Measure |
Tiotropium 5 Microgram (μg)
n=98 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=100 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
|---|---|---|
|
Change From Baseline After 6 Weeks of Treatment for Inspiratory Capacity Measured at the End of Exercise
|
0.256 Litre (L)
Standard Error 0.034
|
0.322 Litre (L)
Standard Error 0.034
|
SECONDARY outcome
Timeframe: Baseline and week 6Population: FAS including participants with available data for change from baseline for FEV1 after 6 weeks of treatment.
Forced Expiratory Volume in 1st second (FEV1) is a standard measurement for the assessment of lung function. The best of 3 efforts was defined as the highest FEV1, each obtained on any of 3 manoeuvres meeting the American Thoracic Society (ATS) criteria (to a maximum of 5 attempts). Measure type is actually Adjusted Mean Change from Baseline.
Outcome measures
| Measure |
Tiotropium 5 Microgram (μg)
n=99 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=103 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
|---|---|---|
|
Change From Baseline After 6 Weeks of Treatment for 1 Hour Post-dose Forced Expiratory Volume
|
0.163 Litre (L)
Standard Error 0.021
|
0.318 Litre (L)
Standard Error 0.021
|
SECONDARY outcome
Timeframe: Baseline and week 6Population: FAS including participants with available data for change from baseline for FVC after 6 weeks of treatment.
Forced Vital Capacity (FVC) is a standard measurement for the assessment of lung function. The best of 3 efforts was defined as the highest FVC, each obtained on any of 3 manoeuvres meeting the American Thoracic Society (ATS) criteria (to a maximum of 5 attempts). Measure type is actually Adjusted Mean Change from Baseline.
Outcome measures
| Measure |
Tiotropium 5 Microgram (μg)
n=99 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=103 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
|---|---|---|
|
Change From Baseline After 6 Weeks of Treatment for 1 Hour Post-dose Forced Vital Capacity
|
0.258 Litre (L)
Standard Error 0.040
|
0.459 Litre (L)
Standard Error 0.039
|
SECONDARY outcome
Timeframe: Baseline and week 6Population: FAS including participants with available data for MBS-S after 6 weeks of treatment.
At 1, 2 and 2.5 min during exercise, patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). At 3 min or end of exercise (if 3 min not achieved), patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). The modified Borg scale is 10-point subjective scoring system, in which a patient rates effort of exertion while performing a particular activity. The scale is 0 to 10, the higher the score, the greater the perceived difficulty. Measure type is actually Adjusted Mean Change from Baseline.
Outcome measures
| Measure |
Tiotropium 5 Microgram (μg)
n=100 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=101 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
|---|---|---|
|
Change From Baseline After 6 Weeks of Treatment for Intensity of Breathlessness (MBS-S) at 1, 2 and 2.5 Minute (Min) During the 3 Min Constant Speed Shuttle Test
1 min
|
-0.685 Unit on Scale
Standard Error 0.081
|
-0.793 Unit on Scale
Standard Error 0.081
|
|
Change From Baseline After 6 Weeks of Treatment for Intensity of Breathlessness (MBS-S) at 1, 2 and 2.5 Minute (Min) During the 3 Min Constant Speed Shuttle Test
2 min
|
-0.839 Unit on Scale
Standard Error 0.102
|
-1.079 Unit on Scale
Standard Error 0.101
|
|
Change From Baseline After 6 Weeks of Treatment for Intensity of Breathlessness (MBS-S) at 1, 2 and 2.5 Minute (Min) During the 3 Min Constant Speed Shuttle Test
2.5 min
|
-0.846 Unit on Scale
Standard Error 0.127
|
-1.164 Unit on Scale
Standard Error 0.126
|
SECONDARY outcome
Timeframe: Baseline and week 6Population: FAS including participants with available data for change from baseline for CRQ-SAI questionnaire after 6 weeks of treatment.
CRQ-SAI refers to the CRQ-Self-administered individualized format as it contains a dyspnea domain that is individualized to each patient. This version was derived from the original CRQ tool \& therefore, is scored on 7-point Likert-type scale (1: maximum impairment to 7: no impairment) for each 4 domains covering: dyspnea, fatigue, emotional function \& mastery. Dyspnea items may be selected from list of 26 suggested items or written in by the patients. The patients are asked to select up to 5 activities associated with breathlessness that they perform frequently and are most important to them. The scores for each question of each domain were added together and divided by the number of questions answered in each domain. The higher scores indicate better health-related quality of life in the respective domain. Measure type is actually Adjusted Mean Change from Baseline.
Outcome measures
| Measure |
Tiotropium 5 Microgram (μg)
n=93 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=96 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
|---|---|---|
|
Change From Baseline After 6 Weeks of Treatment for Chronic Respiratory Questionnaire - Self Administered Individualized (CRQ-SAI) Dyspnoea Domain Score
|
0.640 Unit on Scale
Standard Error 0.091
|
0.610 Unit on Scale
Standard Error 0.089
|
SECONDARY outcome
Timeframe: Baseline and week 6Population: FAS including participants with available data for change from baseline for CRQ-SAS questionnaire after 6 weeks of treatment.
CRQ-SAS was questionnaire to assess patients' perception of COPD and measures the impact of COPD on their life. This version was derived from the original CRQ tool \& therefore, is scored on 7-point Likert-type scale (1: maximum impairment to 7: no impairment) for each 4 domains covering: dyspnea, fatigue, emotional function \& mastery. The CRQ-SAS refers to the CRQ-Self-administered standardized format \& contains 20 questions. The first part of the questionnaire contains 5 standardized dyspnea questions and the patients must indicate how much shortness of breath they have experienced while performing each of these 5 activities. The scores for each question of each domain were added together and divided by the number of questions answered in each domain. The higher scores indicate better health-related quality of life in the respective domain. Measure type is actually Adjusted Mean Change from Baseline.
Outcome measures
| Measure |
Tiotropium 5 Microgram (μg)
n=100 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=102 Participants
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
|---|---|---|
|
Change From Baseline After 6 Weeks of Treatment for Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS) Dyspnoea Domain Score
|
0.325 Unit on Scale
Standard Error 0.088
|
0.415 Unit on Scale
Standard Error 0.087
|
Adverse Events
Tiotropium 5 Microgram (μg)
Tiotropium + Olodaterol 5/5 μg
Total Subjects
Serious adverse events
| Measure |
Tiotropium 5 Microgram (μg)
n=100 participants at risk
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=105 participants at risk
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
Total Subjects
n=106 participants at risk
This patient set was nested within the randomized set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/100 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.95%
1/105 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.94%
1/106 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/100 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.95%
1/105 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.94%
1/106 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/100 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.95%
1/105 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.94%
1/106 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/100 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.95%
1/105 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.94%
1/106 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
1/100 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.00%
0/105 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.94%
1/106 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
|
Nervous system disorders
Coma
|
0.00%
0/100 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.95%
1/105 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.94%
1/106 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/100 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.95%
1/105 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.94%
1/106 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/100 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.95%
1/105 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
0.94%
1/106 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
Other adverse events
| Measure |
Tiotropium 5 Microgram (μg)
n=100 participants at risk
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium (Tio) inhalation solution (2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
Tiotropium + Olodaterol 5/5 μg
n=105 participants at risk
Patients inhaled 2 puffs from the Respimat® Inhaler of the Tiotropium + Olodaterol (Tio+Olo) fixed dose combination (FDC) inhalation solution (2.5/2.5 μg per actuation) once a day, in the morning for a period of 6 weeks.
|
Total Subjects
n=106 participants at risk
This patient set was nested within the randomized set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.
|
|---|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
13.0%
13/100 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
13.3%
14/105 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
21.7%
23/106 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
10.0%
10/100 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
13.3%
14/105 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
20.8%
22/106 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
2/100 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
4.8%
5/105 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
5.7%
6/106 • From first drug administration until 21 days after last drug administration, up to 18 weeks.
Treated set (TS) (This patient set was nested within the Randomised set (RS) and included all patients who were dispensed study medication and were documented to have taken any dose of study medication.) was used for patient safety analyses.
|
Additional Information
Boehringer Ingelheim, Call Centre
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