Trial Outcomes & Findings for Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2) (NCT NCT02006732)
NCT ID: NCT02006732
Last Updated: 2016-01-20
Results Overview
Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
COMPLETED
PHASE3
809 participants
baseline and 12 weeks
2016-01-20
Participant Flow
809 patients were randomised and treated.
Participant milestones
| Measure |
Placebo
Once daily 2 puffs solution of placebo for inhalation with Respimat
|
Tiotropium 5 μg
Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
|
Tiotropium 2.5 μg+ Olodaterol 5 μg
Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
Tiotropium 5 μg + Olodaterol 5 μg
Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
202
|
203
|
202
|
202
|
|
Overall Study
COMPLETED
|
182
|
191
|
193
|
198
|
|
Overall Study
NOT COMPLETED
|
20
|
12
|
9
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Once daily 2 puffs solution of placebo for inhalation with Respimat
|
Tiotropium 5 μg
Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
|
Tiotropium 2.5 μg+ Olodaterol 5 μg
Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
Tiotropium 5 μg + Olodaterol 5 μg
Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
7
|
4
|
2
|
|
Overall Study
Lack of Efficacy
|
6
|
3
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
4
|
1
|
Baseline Characteristics
Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)
Baseline characteristics by cohort
| Measure |
Placebo
n=202 Participants
Once daily 2 puffs solution of placebo for inhalation with Respimat
|
Tiotropium 5 μg
n=203 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
|
Tiotropium 2.5 μg+ Olodaterol 5 μg
n=202 Participants
Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
Tiotropium 5 μg + Olodaterol 5 μg
n=202 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
Total
n=809 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
64.7 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
64.4 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
65.2 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
64.6 years
STANDARD_DEVIATION 8.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
303 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
506 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: Patients from the Full Analysis Set (FAS): This patient set included all randomized and treated patients who had a baseline and at least one postbaseline measurement for any of the primary efficacy endpoints.
Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
Outcome measures
| Measure |
Placebo
n=199 Participants
Once daily 2 puffs solution of placebo for inhalation with Respimat
|
Tiotropium 5 μg
n=201 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
|
Tiotropium 2.5 μg+ Olodaterol 5 μg
n=200 Participants
Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
Tiotropium 5 μg + Olodaterol 5 μg
n=200 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
|---|---|---|---|---|
|
FEV1 AUC0-3h Response
|
-0.006 L
Standard Error 0.014
|
0.188 L
Standard Error 0.013
|
0.279 L
Standard Error 0.014
|
0.293 L
Standard Error 0.013
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: Patients from FAS
Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FEV1 measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FEV1 response was defines as trough FEV1 minus baseline FEV1. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
Outcome measures
| Measure |
Placebo
n=193 Participants
Once daily 2 puffs solution of placebo for inhalation with Respimat
|
Tiotropium 5 μg
n=197 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
|
Tiotropium 2.5 μg+ Olodaterol 5 μg
n=200 Participants
Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
Tiotropium 5 μg + Olodaterol 5 μg
n=199 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
|---|---|---|---|---|
|
Trough FEV1 Response (Change From Baseline)
|
-0.003 L
Standard Error 0.014
|
0.124 L
Standard Error 0.013
|
0.166 L
Standard Error 0.013
|
0.163 L
Standard Error 0.013
|
PRIMARY outcome
Timeframe: 12 weeks treatmentPopulation: Patients from FAS
The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life). The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
Outcome measures
| Measure |
Placebo
n=184 Participants
Once daily 2 puffs solution of placebo for inhalation with Respimat
|
Tiotropium 5 μg
n=192 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
|
Tiotropium 2.5 μg+ Olodaterol 5 μg
n=195 Participants
Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
Tiotropium 5 μg + Olodaterol 5 μg
n=197 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
|---|---|---|---|---|
|
St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study
|
42.575 units on a scale
Standard Error 0.711
|
39.729 units on a scale
Standard Error 0.694
|
38.909 units on a scale
Standard Error 0.691
|
38.011 units on a scale
Standard Error 0.683
|
PRIMARY outcome
Timeframe: 12 weeks treatmentPopulation: Patients from FAS after combining the data from this and the replicate study NCT01964352
This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life). The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
Outcome measures
| Measure |
Placebo
n=370 Participants
Once daily 2 puffs solution of placebo for inhalation with Respimat
|
Tiotropium 5 μg
n=384 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
|
Tiotropium 2.5 μg+ Olodaterol 5 μg
n=394 Participants
Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
Tiotropium 5 μg + Olodaterol 5 μg
n=393 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
|---|---|---|---|---|
|
St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352
|
42.265 units on a scale
Standard Error 0.511
|
39.694 units on a scale
Standard Error 0.498
|
38.419 units on a scale
Standard Error 0.494
|
37.597 units on a scale
Standard Error 0.492
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Patients from FAS
Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FVC measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FVC response was defined as trough FVC minus baseline FVC. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
Outcome measures
| Measure |
Placebo
n=193 Participants
Once daily 2 puffs solution of placebo for inhalation with Respimat
|
Tiotropium 5 μg
n=197 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
|
Tiotropium 2.5 μg+ Olodaterol 5 μg
n=200 Participants
Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
Tiotropium 5 μg + Olodaterol 5 μg
n=199 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
|---|---|---|---|---|
|
Trough Forced Vital Capacity (FVC) Response (Change From Baseline)
|
-0.021 L
Standard Error 0.024
|
0.170 L
Standard Error 0.023
|
0.284 L
Standard Error 0.023
|
0.231 L
Standard Error 0.023
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Patients from FAS
Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9). The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
Outcome measures
| Measure |
Placebo
n=183 Participants
Once daily 2 puffs solution of placebo for inhalation with Respimat
|
Tiotropium 5 μg
n=192 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
|
Tiotropium 2.5 μg+ Olodaterol 5 μg
n=195 Participants
Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
Tiotropium 5 μg + Olodaterol 5 μg
n=197 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
|---|---|---|---|---|
|
TDI Focal Score Based on Data From This Individual Study
|
0.337 Units on a scale
Standard Error 0.195
|
0.950 Units on a scale
Standard Error 0.191
|
1.599 Units on a scale
Standard Error 0.189
|
1.531 Units on a scale
Standard Error 0.187
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Patients from FAS after combining the data from this and the replicate study NCT01964352
This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9). The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
Outcome measures
| Measure |
Placebo
n=370 Participants
Once daily 2 puffs solution of placebo for inhalation with Respimat
|
Tiotropium 5 μg
n=385 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
|
Tiotropium 2.5 μg+ Olodaterol 5 μg
n=394 Participants
Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
Tiotropium 5 μg + Olodaterol 5 μg
n=393 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
|---|---|---|---|---|
|
TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352
|
0.111 Units on a scale
Standard Error 0.139
|
1.140 Units on a scale
Standard Error 0.136
|
1.722 Units on a scale
Standard Error 0.134
|
1.734 Units on a scale
Standard Error 0.134
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Patients from FAS
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward-Roger approximation of denominator degrees of freedom.
Outcome measures
| Measure |
Placebo
n=199 Participants
Once daily 2 puffs solution of placebo for inhalation with Respimat
|
Tiotropium 5 μg
n=201 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
|
Tiotropium 2.5 μg+ Olodaterol 5 μg
n=200 Participants
Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
Tiotropium 5 μg + Olodaterol 5 μg
n=200 Participants
Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
|---|---|---|---|---|
|
FVC AUC0-3h Response (Change From Baseline)
|
-0.018 L
Standard Error 0.025
|
0.266 L
Standard Error 0.023
|
0.436 L
Standard Error 0.024
|
0.414 L
Standard Error 0.023
|
Adverse Events
Placebo
Tiotropium 5 μg
Tiotropium 2.5 μg +Olodaterol 5 μg
Tiotropium 5 μg +Olodaterol 5 μg
Serious adverse events
| Measure |
Placebo
n=202 participants at risk
Once daily 2 puffs solution of placebo for inhalation with Respimat
|
Tiotropium 5 μg
n=203 participants at risk
Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
|
Tiotropium 2.5 μg +Olodaterol 5 μg
n=202 participants at risk
Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
Tiotropium 5 μg +Olodaterol 5 μg
n=202 participants at risk
Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/202 • up to 112 days
|
0.00%
0/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.50%
1/202 • up to 112 days
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/202 • up to 112 days
|
0.99%
2/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.50%
1/202 • up to 112 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/202 • up to 112 days
|
0.00%
0/203 • up to 112 days
|
0.50%
1/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.50%
1/202 • up to 112 days
|
0.49%
1/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.50%
1/202 • up to 112 days
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/202 • up to 112 days
|
0.49%
1/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/202 • up to 112 days
|
0.00%
0/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.50%
1/202 • up to 112 days
|
|
Cardiac disorders
Angina pectoris
|
0.50%
1/202 • up to 112 days
|
0.00%
0/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.50%
1/202 • up to 112 days
|
0.00%
0/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Eye disorders
Blindness
|
0.00%
0/202 • up to 112 days
|
0.49%
1/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/202 • up to 112 days
|
0.49%
1/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/202 • up to 112 days
|
0.49%
1/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/202 • up to 112 days
|
0.49%
1/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Infections and infestations
Diverticulitis
|
0.50%
1/202 • up to 112 days
|
0.00%
0/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/202 • up to 112 days
|
0.00%
0/203 • up to 112 days
|
0.50%
1/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/202 • up to 112 days
|
0.99%
2/203 • up to 112 days
|
0.50%
1/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/202 • up to 112 days
|
0.00%
0/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.50%
1/202 • up to 112 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.50%
1/202 • up to 112 days
|
0.00%
0/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/202 • up to 112 days
|
0.49%
1/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/202 • up to 112 days
|
0.00%
0/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.50%
1/202 • up to 112 days
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/202 • up to 112 days
|
0.49%
1/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/202 • up to 112 days
|
0.00%
0/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.50%
1/202 • up to 112 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/202 • up to 112 days
|
0.00%
0/203 • up to 112 days
|
0.50%
1/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/202 • up to 112 days
|
0.00%
0/203 • up to 112 days
|
0.50%
1/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/202 • up to 112 days
|
0.49%
1/203 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
0.00%
0/202 • up to 112 days
|
Other adverse events
| Measure |
Placebo
n=202 participants at risk
Once daily 2 puffs solution of placebo for inhalation with Respimat
|
Tiotropium 5 μg
n=203 participants at risk
Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
|
Tiotropium 2.5 μg +Olodaterol 5 μg
n=202 participants at risk
Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
Tiotropium 5 μg +Olodaterol 5 μg
n=202 participants at risk
Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.9%
14/202 • up to 112 days
|
3.4%
7/203 • up to 112 days
|
8.4%
17/202 • up to 112 days
|
4.5%
9/202 • up to 112 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
12/202 • up to 112 days
|
2.5%
5/203 • up to 112 days
|
2.5%
5/202 • up to 112 days
|
1.5%
3/202 • up to 112 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.9%
14/202 • up to 112 days
|
2.0%
4/203 • up to 112 days
|
2.0%
4/202 • up to 112 days
|
0.99%
2/202 • up to 112 days
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Other - 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