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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003879-29 | EudraCT Number |
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This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.
Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDC of tiotropium + olodaterol | Experimental | Fixed Dose Combination of tiotropium + olodaterol |
|
| Free combination tiotropium + olodaterol | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDC of tiotropium + olodaterol | Drug | Fixed Dose Combination of tiotropium + olodaterol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment | This outcome measure presents FEV1 after 28 days of treatment (measurement on Day 29). Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), and was measured at 24 hours (+/- 10 minutes) after trial medication administration at Visit 5. The FEV1 measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement. | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment | This outcome measure presents trough FVC after 28 days of treatment (measurement on Day 29). The FVC measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement for FVC. | Day 29 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordination Dr. Robert Voves, 8330 Feldbach | Feldbach | 8330 | Austria | |||
| KH d. Elisabethinen Linz |
Definition: Randomised Set (RS): This patient set is nested within the OLTS and includes all patients who signed the informed consent form and were also randomised, regardless of whether the patient was treated with study medication or not.
Definition: Open-Label Treated Set (OLTS): This patient set includes all patients who signed the informed consent and were dispensed open-label study medication during the run-in period prior to randomisation and were documented to have taken any dose of this medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | T+O 5/5 | The subjects were administered Tiotropium (T) + Olodaterol (O) Fixed Dose Combination (FDC) solution for inhalation 2.5 μg/2.5 μg per actuation, 2 inhalations orally once daily via RESPIMAT® inhaler. Placebo matching Tiotropium solution was administered 2 inhalations once daily via RESPIMAT® inhaler. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug |
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| Tiotropium | Drug |
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| Olodaterol | Drug |
|
| Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28 | This outcome measure presents COPD assessment test score on Day 28. The COPD Assessment Test™ is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health). The CAT measurement on Visit 4 prior to the first dose of double-blind study drug was the baseline for CAT. | Day 28 |
| Linz |
| 4020 |
| Austria |
| Aarhus Universitetshospital | Aarhus | 8000 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Regionshospitalet Silkeborg | Silkeborg | 8600 | Denmark |
| Jorvin sairaala | Espoo | FI-02740 | Finland |
| HYKS Keuhkosairauksien | Helsinki | 00029 | Finland |
| TAYS, Keuhkotautien poliklinikka | Tampere | FI-33520 | Finland |
| TYKS, Keuhkosairauksien klinikka, Turku | Turku | 20520 | Finland |
| Terveystalo Pulssi, Turku | Turku | FI-20100 | Finland |
| HOP Louis Pradel | Bron | 69677 | France |
| CLI du Parc, Pneumo, Castelnau le Lez | Castelnau-le-Lez | 34170 | France |
| CAB Pigearias B., Pneumo, Nice | Nice | 06000 | France |
| CAB Dupouy J, Pneumo, Nîmes | Nîmes | 30900 | France |
| HOP Cochin | Paris | 75014 | France |
| HOP Haut-Lévêque | Pessac | 33604 | France |
| HOP Maison Blanche | Reims | 51092 | France |
| INS A.Tzanck,Pneumo,St Laurent du Var | Saint-Laurent-du-Var | 06721 | France |
| CAB Lejay D, MG, Vieux Condé | Vieux-Condé | 59690 | France |
| Univ. Clinic of Respiratory and Allergic Diseases, Golnik | Golnik | 4204 | Slovenia |
| Verboten Kopriva Renata - Private practice, Litija | Litija | 1270 | Slovenia |
| Arjana Macek d.o.o. | Ljubljana | 1000 | Slovenia |
| T 5/O 5 |
The subjects were administered Tiotropium solution for inhalation, 2.5 μg per actuation + Olodaterol solution for inhalation, 2.5 μg per actuation as a free combination. Two inhalations were administered once daily (a.m. dosing) via RESPIMAT® inhaler for both Tiotropium and Olodaterol. |
| COMPLETED |
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| NOT COMPLETED |
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Treated set [TS]: This patient set is nested within the RS and includes all patients who were dispensed study medication and were documented to have taken any dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | T+O 5/5 | The subjects were administered Tiotropium (T) + Olodaterol (O) Fixed Dose Combination (FDC) solution for inhalation 2.5 μg/2.5 μg per actuation, 2 inhalations orally once daily via RESPIMAT® inhaler. Placebo matching Tiotropium solution was administered 2 inhalations once daily via RESPIMAT® inhaler. |
| BG001 | T 5/O 5 | The subjects were administered Tiotropium solution for inhalation, 2.5 μg per actuation + Olodaterol solution for inhalation, 2.5 μg per actuation as a free combination. Two inhalations were administered once daily (a.m. dosing) via RESPIMAT® inhaler for both Tiotropium and Olodaterol. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment | This outcome measure presents FEV1 after 28 days of treatment (measurement on Day 29). Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), and was measured at 24 hours (+/- 10 minutes) after trial medication administration at Visit 5. The FEV1 measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement. | Full Analysis Set (FAS): This patient set is nested within the TS and includes patients who had a baseline measurement and at least one post-baseline measurement for the primary endpoint. | Posted | Mean | Standard Error | Liter | Day 29 |
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| Secondary | Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment | This outcome measure presents trough FVC after 28 days of treatment (measurement on Day 29). The FVC measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement for FVC. | FAS. | Posted | Mean | Standard Error | Liter | Day 29 |
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| Secondary | Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28 | This outcome measure presents COPD assessment test score on Day 28. The COPD Assessment Test™ is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health). The CAT measurement on Visit 4 prior to the first dose of double-blind study drug was the baseline for CAT. | FAS. One patient in the T 5/O 5 free combination group had missing data for the CAT questionnaire. | Posted | Mean | Standard Error | Score on scale | Day 28 |
|
From first drug administration until 28 days after last drug administration, up to 49 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T+O 5/5 | The subjects were administered Tiotropium (T) + Olodaterol (O) Fixed Dose Combination (FDC) solution for inhalation 2.5 μg/2.5 μg per actuation, 2 inhalations orally once daily via RESPIMAT® inhaler. Placebo matching Tiotropium solution was administered 2 inhalations once daily via RESPIMAT® inhaler. | 1 | 110 | 9 | 110 | ||
| EG001 | T 5/O 5 | The subjects were administered Tiotropium solution for inhalation, 2.5 μg per actuation + Olodaterol solution for inhalation, 2.5 μg per actuation as a free combination. Two inhalations were administered once daily (a.m. dosing) via RESPIMAT® inhaler for both Tiotropium and Olodaterol. | 2 | 111 | 9 | 111 | ||
| EG002 | Total | The total number of subjects who were administered T+O 5/5 or T 5/O 5. | 3 | 221 | 18 | 221 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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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 | 1800-243-0127 | 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 |
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| ID | Term |
|---|---|
| C549647 | olodaterol |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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