Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014880-38 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| olodaterol (BI 1744) low and placebo | Experimental | low dose inhaled olodaterol orally once daily from the Respimat inhaler |
|
| olodaterol (BI 1744) low and low tio | Experimental | low dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily |
|
| olodaterol (BI 1744) low and medium tio | Experimental | low dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily |
|
| olodaterol (BI 1744) low and high tio | Experimental | low dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily |
|
| olodaterol (BI 1744) high and placebo | Experimental | high dose inhaled olodaterol orally once daily from the Respimat inhaler |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olodaterol (BI 1744) low | Drug | olodaterol (BI 1744) low |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 Response | Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Vital Capacity (FVC) Response | Adjusted means of trough FVC (forced vital capacity) response [L] after 4 weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. |
Not provided
Inclusion criteria:
a post-bronchodilator forced expiratory flow in 1 second (FEV1) =<30% of predicted normal and <80% of predicted normal and a post bronchodilator FEV1 / forced vital capacity (FVC) <70% at Visit 1 4. Male or female patients, 40 years of age or older. 5. Patients must be current or ex-smokers with a smoking history of more than 10 pack years
Exclusion criteria:
a diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists) a diagnosis of paroxysmal tachycardia - Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit a diagnosis of clinically relevant cardiac arrhythmia a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
medications that prolong the QT/QTc interval oral Beta-adrenergics oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
- Pregnant or nursing women
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1237.18.02004 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada | |||
| 1237.18.02005 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26404912 | Derived | Aalbers R, Maleki-Yazdi MR, Hamilton A, Waitere-Wijker S, Zhao Y, Amatto VC, Schmidt O, Bjermer L. Randomized, Double-Blind, Dose-Finding Study for Tiotropium when Added to Olodaterol, Administered via the Respimat(R) Inhaler in Patients with Chronic Obstructive Pulmonary Disease. Adv Ther. 2015 Sep;32(9):809-22. doi: 10.1007/s12325-015-0239-8. Epub 2015 Sep 24. |
Not provided
Not provided
This was a randomised, 4-period incomplete cross-over trial. 233 patients were randomized to one of 14 treatment sequences and 232 of them were treated. It was a double-blind trial in which each treatment period lasted 4 weeks with a washout period of 21 days between each.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Olodaterol (BI 1744) high and low tio | Experimental | high dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily |
|
| Olodaterol (BI 1744) high and medium tio | Experimental | high dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily |
|
| Olodaterol (BI 1744) high and high tio | Experimental | high dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily |
|
| low tiotropium bromide | Drug | low tiotropium bromide |
|
| olodaterol (BI 1744) high | Drug | olodaterol (BI 1744) high |
|
| medium tiotropium bromide | Drug | medium tiotropium bromide |
|
| high tiotropium bromide | Drug | high tiotropium bromide |
|
| Placebo | Drug | Placebo |
|
| Respimat | Device | Respimat inhaler |
|
| Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29 |
| FEV1 AUC 0-3h and FEV1 AUC 0-6h Response | Adjusted means of forced expiratory volume in one second (FEV1) area under the curve (AUC) 0-3 hour and AUC 0-6 hour responses [L] after 4 weeks treatment calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29 |
| FEV1 AUC 0-3h Response After the First Dose | Adjusted means of Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-3h response [L] after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1 |
| FEV1 Peak 0-3h Response | Adjusted means of the FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29 |
| FEV1 Peak 0-3h Response After the First Dose | Adjusted means of the FEV1 peak 0-3h response [L] after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1 |
| FVC AUC 0-3h and FEV1 AUC 0-6h Responses | Adjusted means of the FVC AUC 0-3h and AUC 0-6h responses [L] after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29 |
| FVC AUC 0-3h Response After First Dose | Adjusted means of the FVC AUC 0-3h response [L] after first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on days 1 |
| FVC Peak 0-3h Response | Adjusted means of the FVC peak 0-3h response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29 |
| FVC Peak 0-3h Response After the First Dose | Adjusted mean of the FVC peak 0-3h response [L] after the first dose. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1 |
| PEF AUC 0-3h and AUC 0-6h Responses | Adjusted means of the Peak Expiratory Flow (PEF) AUC 0-3h and AUC 0-6h responses in Litres / minute (L/min) after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29 |
| PEF AUC 0-3h Response After the First Dose | Adjusted means of the Area under the curve from 0 to 3 h response in Litres / minutes of the peak expiratory flow after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1 |
| PEF Peak 0-3h Response | Adjusted means of the peak expiratory flow from 0 to 3 hours (PEF peak 0-3h) response in L/min after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29 |
| PEF Peak 0-3h Response After the First Dose | Adjusted means of the Peak Expiratory flow from 0 to 3 hours response in L/min after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1 |
| Individual FEV1 Measurements at Each Time Point on Day 29 | Adjusted means of the FEV1 measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29 |
| Individual FVC Measurements at Each Time Point on Day 29 | Adjusted means of the FVC measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29 |
| Individual PEF Measurements at Each Time Point on Day 29 | Adjusted means of the PEF measurements [L/min] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29 |
| Weekly Mean Number of Puffs of Rescue Medication Used Per Day | Adjusted means of the weekly mean number of puffs of rescue medication during the whole day : the rescue medication was a salbutamol [albuterol] dose (100 mcg per puff). | Weeks 1 and 4 |
| Physicians Global Evaluation | Adjusted means of the Physicians Global Evaluation of the patient's respiratory condition on days 1 and 29. The score was evaluated on a 8-points scale :
| Days 1 and 29 |
| Patients Global Rating | Adjusted means of the Global Rating of the patients' health (respiratory condition) on day 29. The score was evaluated on a 7-point scale :
| Day 29 |
| Pulse Rate Recorded in Conjunction With Spirometry | Pulse rate recorded in conjunction with spirometry change from baseline at 30 minutes post-dose on day 29 in beats per minute (bpm). | Baseline and 30 min post-dose on day 29 |
| Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry | Systolic and diastolic blood pressure recorded in conjunction with spirometry change from baseline on day 29 in millimetres of mercury (mmHg). | Baseline and 30 min post-dose on day 29 |
| Grimsby |
| Ontario |
| Canada |
| 1237.18.02001 Boehringer Ingelheim Investigational Site | Mississauga | Ontario | Canada |
| 1237.18.02008 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1237.18.02002 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| 1237.18.02003 Boehringer Ingelheim Investigational Site | Point Claire | Quebec | Canada |
| 1237.18.02009 Boehringer Ingelheim Investigational Site | Québec | Quebec | Canada |
| 1237.18.02007 Boehringer Ingelheim Investigational Site | Sherbrooke | Quebec | Canada |
| 1237.18.02011 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan | Canada |
| 1237.18.49009 Boehringer Ingelheim Investigational Site | Aschaffenburg | Germany |
| 1237.18.49012 Boehringer Ingelheim Investigational Site | Bamberg | Germany |
| 1237.18.49005 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1237.18.49004 Boehringer Ingelheim Investigational Site | Frankfurt | Germany |
| 1237.18.49011 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1237.18.49010 Boehringer Ingelheim Investigational Site | Koblenz | Germany |
| 1237.18.49007 Boehringer Ingelheim Investigational Site | Mannheim | Germany |
| 1237.18.49001 Boehringer Ingelheim Investigational Site | Potsdam | Germany |
| 1237.18.49006 Boehringer Ingelheim Investigational Site | Rodgau-Dudenhofen | Germany |
| 1237.18.49002 Boehringer Ingelheim Investigational Site | Rüdersdorf | Germany |
| 1237.18.49003 Boehringer Ingelheim Investigational Site | Weinheim | Germany |
| 1237.18.49008 Boehringer Ingelheim Investigational Site | Wiesloch | Germany |
| 1237.18.31004 Boehringer Ingelheim Investigational Site | Almelo | Netherlands |
| 1237.18.31006 Boehringer Ingelheim Investigational Site | Amsterdam | Netherlands |
| 1237.18.31008 Boehringer Ingelheim Investigational Site | Eindhoven | Netherlands |
| 1237.18.31001 Boehringer Ingelheim Investigational Site | Groningen | Netherlands |
| 1237.18.31007 Boehringer Ingelheim Investigational Site | Hengelo | Netherlands |
| 1237.18.31005 Boehringer Ingelheim Investigational Site | Hoorn | Netherlands |
| 1237.18.31002 Boehringer Ingelheim Investigational Site | Veldhoven | Netherlands |
| 1237.18.31003 Boehringer Ingelheim Investigational Site | Zutphen | Netherlands |
| 1237.18.46003 Boehringer Ingelheim Investigational Site | Boden | Sweden |
| 1237.18.46002 Boehringer Ingelheim Investigational Site | Gothenburg | Sweden |
| 1237.18.46001 Boehringer Ingelheim Investigational Site | Lund | Sweden |
| 1237.18.46004 Boehringer Ingelheim Investigational Site | Stockholm | Sweden |
| Completed Olo 5 |
|
| Completed T+O 1.25/5 |
|
| Completed T+O 2.5/5 |
|
| Completed T+O 5/5 |
|
| Completed Olo 10 |
|
| Completed T+O 1.25/10 |
|
| Completed T+O 2.5/10 |
|
| Completed T+O 5/10 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated Set (TS) which comprised all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Trough FEV1 Response | Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | Full Analysis Set (FAS) which comprised all patients in the treated set who provided baseline (study baseline) data and at least 1 on-treatment efficacy value for the primary endpoint after 4 weeks on treatment. | Posted | Mean | Standard Deviation | Litres | Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Forced Vital Capacity (FVC) Response | Adjusted means of trough FVC (forced vital capacity) response [L] after 4 weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS which included all patients who were dispensed study medication and who provided baseline and at least 1 on-treatment efficacy value for the primary endpoint after 4 weeks on treatment. | Posted | Mean | Standard Error | Litres | Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FEV1 AUC 0-3h and FEV1 AUC 0-6h Response | Adjusted means of forced expiratory volume in one second (FEV1) area under the curve (AUC) 0-3 hour and AUC 0-6 hour responses [L] after 4 weeks treatment calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Deviation | Litres | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FEV1 AUC 0-3h Response After the First Dose | Adjusted means of Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-3h response [L] after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Deviation | Litres | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FEV1 Peak 0-3h Response | Adjusted means of the FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Error | Litres | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FEV1 Peak 0-3h Response After the First Dose | Adjusted means of the FEV1 peak 0-3h response [L] after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Error | Litres | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FVC AUC 0-3h and FEV1 AUC 0-6h Responses | Adjusted means of the FVC AUC 0-3h and AUC 0-6h responses [L] after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Error | Litres | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FVC AUC 0-3h Response After First Dose | Adjusted means of the FVC AUC 0-3h response [L] after first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Error | Litres | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on days 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FVC Peak 0-3h Response | Adjusted means of the FVC peak 0-3h response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Error | Litres | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FVC Peak 0-3h Response After the First Dose | Adjusted mean of the FVC peak 0-3h response [L] after the first dose. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Error | Litres | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PEF AUC 0-3h and AUC 0-6h Responses | Adjusted means of the Peak Expiratory Flow (PEF) AUC 0-3h and AUC 0-6h responses in Litres / minute (L/min) after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Error | L/min | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PEF AUC 0-3h Response After the First Dose | Adjusted means of the Area under the curve from 0 to 3 h response in Litres / minutes of the peak expiratory flow after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Error | L/min | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PEF Peak 0-3h Response | Adjusted means of the peak expiratory flow from 0 to 3 hours (PEF peak 0-3h) response in L/min after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Error | L/min | Baseline 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PEF Peak 0-3h Response After the First Dose | Adjusted means of the Peak Expiratory flow from 0 to 3 hours response in L/min after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Error | L/min | Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Individual FEV1 Measurements at Each Time Point on Day 29 | Adjusted means of the FEV1 measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Error | Litres | Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Individual FVC Measurements at Each Time Point on Day 29 | Adjusted means of the FVC measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Error | Litres | Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Individual PEF Measurements at Each Time Point on Day 29 | Adjusted means of the PEF measurements [L/min] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug. | FAS | Posted | Mean | Standard Error | L/min | Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Weekly Mean Number of Puffs of Rescue Medication Used Per Day | Adjusted means of the weekly mean number of puffs of rescue medication during the whole day : the rescue medication was a salbutamol [albuterol] dose (100 mcg per puff). | FAS | Posted | Mean | Standard Error | number of puffs per day | Weeks 1 and 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Physicians Global Evaluation | Adjusted means of the Physicians Global Evaluation of the patient's respiratory condition on days 1 and 29. The score was evaluated on a 8-points scale :
| FAS | Posted | Mean | Standard Error | units on a scale | Days 1 and 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patients Global Rating | Adjusted means of the Global Rating of the patients' health (respiratory condition) on day 29. The score was evaluated on a 7-point scale :
| FAS | Posted | Mean | Standard Error | units on a scale | Day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pulse Rate Recorded in Conjunction With Spirometry | Pulse rate recorded in conjunction with spirometry change from baseline at 30 minutes post-dose on day 29 in beats per minute (bpm). | TS which comprised all patients who were dispensed study medication, were documented to have taken at least 1 dose of investigational treatment and had available data for pulse rate at baseline and day 29. | Posted | Mean | Standard Deviation | bpm | Baseline and 30 min post-dose on day 29 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry | Systolic and diastolic blood pressure recorded in conjunction with spirometry change from baseline on day 29 in millimetres of mercury (mmHg). | TS which comprised all patients who were dispensed study medication, were documented to have taken at least 1 dose of investigational treatment and had available data for systolic and diastolic blood pressure at baseline and day 29. | Posted | Mean | Standard Deviation | mmHg | Baseline and 30 min post-dose on day 29 |
|
From first drug administration until 21 days after the last administration, up to 75 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olo 5 | Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | 4 | 108 | 15 | 108 | ||
| EG001 | T+O 1.25/5 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. | 1 | 109 | 15 | 109 | ||
| EG002 | T+O 2.5/5 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. | 3 | 113 | 11 | 113 | ||
| EG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. | 1 | 109 | 11 | 109 | ||
| EG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. | 2 | 109 | 12 | 109 | ||
| EG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. | 1 | 110 | 13 | 110 | ||
| EG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. | 5 | 110 | 7 | 110 | ||
| EG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. | 0 | 111 | 6 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MEDDRA 13.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MEDDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 13.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MEDDRA 13.1 | Systematic Assessment |
| |
| Aspergillosis | Infections and infestations | MEDDRA 13.1 | Systematic Assessment |
| |
| Bronchiectasis | Infections and infestations | MEDDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA 13.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MEDDRA 13.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MEDDRA 13.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MEDDRA 13.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MEDDRA 13.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MEDDRA 13.1 | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MEDDRA 13.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 13.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MEDDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MEDDRA 13.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 13.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C549647 | olodaterol |
Not provided
Not provided
Not provided
| Mean Difference (Final Values) |
| 0.065 |
| Standard Error of the Mean |
| 0.019 |
| 2-Sided |
| 95 |
| 0.027 |
| 0.103 |
Difference calculated as T+O 2.5/5 minus Olo 5 |
| No |
| Superiority or Other |
| Mixed Models Analysis | Mean Difference (Final Values) | 0.084 | Standard Error of the Mean | 0.020 | 2-Sided | 95 | 0.046 | 0.122 | Difference calculated as T+O 5/5 minus Olo 5 | No | Superiority or Other |
| Mixed Models Analysis | Mean Difference (Final Values) | 0.011 | Standard Error of the Mean | 0.019 | 2-Sided | 95 | -0.027 | 0.049 | Difference calculated as T+O 2.5/5 minus T+O 1.25/5 | No | Superiority or Other |
| Mixed Models Analysis | Mean Difference (Final Values) | 0.030 | Standard Error of the Mean | 0.020 | 2-Sided | 95 | -0.008 | 0.069 | Difference calculated as T+O 5/5 minus T+O 1.25/5 | No | Superiority or Other |
| Mixed Models Analysis | Mean Difference (Final Values) | 0.019 | Standard Error of the Mean | 0.019 | 2-Sided | 95 | -0.019 | 0.058 | Difference calculated as T+O 5/5 minus T+O 2.5/5 | No | Superiority or Other |
| Mixed Models Analysis | Mean Difference (Final Values) | 0.051 | Standard Error of the Mean | 0.019 | 2-Sided | 95 | 0.013 | 0.089 | Difference calculated as T+O 1.25/10 minus Olo 10 | No | Superiority or Other |
| Mixed Models Analysis | Mean Difference (Final Values) | 0.083 | Standard Error of the Mean | 0.019 | 2-Sided | 95 | 0.045 | 0.122 | Difference calculated as T+O 2.5/10 minus Olo 10 | No | Superiority or Other |
| Mixed Models Analysis | Mean Difference (Final Values) | 0.080 | Standard Error of the Mean | 0.020 | 2-Sided | 95 | 0.042 | 0.119 | Difference calculated as T+O 5/10 minus Olo 10 | No | Superiority or Other |
| Mixed Models Analysis | Mean Difference (Final Values) | 0.033 | Standard Error of the Mean | 0.020 | 2-Sided | 95 | -0.006 | 0.071 | Difference calculated as T+O 2.5/10 minus T+O 1.25/10 | No | Superiority or Other |
| Mixed Models Analysis | Mean Difference (Final Values) | 0.030 | Standard Error of the Mean | 0.019 | 2-Sided | 95 | -0.009 | 0.068 | Difference calculated as T+O 5/10 minus T+O 1.25/10 | No | Superiority or Other |
| Mixed Models Analysis | Mean Difference (Final Values) | -0.003 | Standard Error of the Mean | 0.019 | 2-Sided | 95 | -0.041 | 0.035 | Difference calculated as T+O 5/10 minus T+O 2.5/10 | No | Superiority or Other |
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| OG003 |
| T+O 5/5 |
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| OG003 |
| T+O 5/5 |
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| OG003 |
| T+O 5/5 |
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| T+O 5/5 |
Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
|
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|
| OG003 | T+O 5/5 | Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG004 | Olo 10 | Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning. |
| OG005 | T+O 1.25/10 | Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG006 | T+O 2.5/10 | Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
| OG007 | T+O 5/10 | Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning. |
|
|