A Phase 4 interventional study of FDC of tiotropium + olodaterol and Placebo in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 22 sites in 5 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-08-17.
Sponsored by Boehringer Ingelheim · Phase 4, Interventional, and Treatment
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 221 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Fixed Dose Combination of tiotropium + olodaterol
Drug: FDC of tiotropium + olodaterol · Drug: Placebo
Drug: Tiotropium · Drug: Olodaterol
Fixed Dose Combination of tiotropium + olodaterol
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.
Time frame: Day 29
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.
Time frame: Day 29
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.
Time frame: Day 28
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.
| Milestone | T+O 5/5 | T 5/O 5 |
|---|---|---|
| Started | 110 | 111 |
| Completed | 109 | 111 |
| Not completed | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
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.
| Liter | T+O 5/5 | T 5/O 5 |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment | 1.422 ± 0.016 | 1.399 ± 0.016 |
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.
| Liter | T+O 5/5 | T 5/O 5 |
|---|---|---|
| Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment | 3.126 ± 0.024 | 3.121 ± 0.024 |
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.
| Score on scale | T+O 5/5 | T 5/O 5 |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28 | 15.423 ± 0.377 | 15.750 ± 0.379 |
Collected over From first drug administration until 28 days after last drug administration, up to 49 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| T+O 5/5 | — | 1/110 (0.9%) | 9/110 (8.2%) |
| T 5/O 5 | — | 2/111 (1.8%) | 9/111 (8.1%) |
| Total | — | 3/221 (1.4%) | 18/221 (8.1%) |
| Event | T+O 5/5 | T 5/O 5 | Total |
|---|---|---|---|
| Cardiac failureCardiac disorders | 1/110 | 0/111 | 1/221 |
| Left ventricular failureCardiac disorders | 0/110 | 1/111 | 1/221 |
| Deep vein thrombosisVascular disorders | 0/110 | 1/111 | 1/221 |
| Event | T+O 5/5 | T 5/O 5 | Total |
|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 9/110 | 9/111 | 18/221 |
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.
| Age, Continuous(Years) | T+O 5/5 | T 5/O 5 | Total |
|---|---|---|---|
| Mean | 66.5 ± 7.1 | 66.5 ± 6.4 | 66.5 ± 6.8 |
| Sex: Female, Male(Participants) | T+O 5/5 | T 5/O 5 | Total |
|---|---|---|---|
| Female | 33 | 30 | 63 |
| Male | 77 | 81 | 158 |
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim