Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01785433 | To Compare the Pharmacokinetics of Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease (COPD) | PHASE1 | COMPLETED | 36 | — | — | Jan 1, 2013 | Aug 1, 2013 | Aug 11, 2014 | 5 | Germany |
To evaluate the PK of Tiotropium Hydrofluoroalkane (HFA) Breath Actuated Inhaler (BAI) (4.5 mcg/day and 9 mcg/day) to SPIRIVA® HandiHaler® and Spiriva® Respimat®
To evaluate the PK of Tiotropium HFA BAI (4.5 mcg/day and 9 mcg/day) to SPIRIVA® HandiHaler® and Spiriva® Respimat®
| Arm | Type | Description |
|---|---|---|
| Treatment ABCD | EXPERIMENTAL | The following treatments are to be studied in a 4-period, crossover design with once daily (QD) dosing for 7 days and at least 21 day washout period between treatments: Treatment A: Tiotropium HFA BAI 4.5 mcg/day Treatment B: Tiotropium HFA BAI 9.0 mcg/day Treatment C: SPIRIVA® HandiHaler® 18 mcg/day Treatment D: Spiriva® Respimat® 5 mcg/day |
| Treatment BDAC | EXPERIMENTAL | The following treatments are to be studied in a 4-period, crossover design with once daily (QD) dosing for 7 days and at least 21 day washout period between treatments: Treatment B: Tiotropium HFA BAI 9.0 mcg/day Treatment D: Spiriva® Respimat® 5 mcg/day Treatment A: Tiotropium HFA BAI 4.5 mcg/day Treatment C: SPIRIVA® HandiHaler® 18 mcg/day |
| Treatment CADB | EXPERIMENTAL | The following treatments are to be studied in a 4-period, crossover design with once daily (QD) dosing for 7 days and at least 21 day washout period between treatments: Treatment C: SPIRIVA® HandiHaler® 18 mcg/day Treatment A: Tiotropium HFA BAI 4.5 mcg/day Treatment D: Spiriva® Respimat® 5 mcg/day Treatment B: Tiotropium HFA BAI 9.0 mcg/day |
| Treatment DCBA | EXPERIMENTAL | The following treatments are to be studied in a 4-period, crossover design with once daily (QD) dosing for 7 days and at least 21 day washout period between treatments: Treatment D: Spiriva® Respimat® 5 mcg/day Treatment C: SPIRIVA® HandiHaler® 18 mcg/day Treatment B: Tiotropium HFA BAI 9.0 mcg/day Treatment A: Tiotropium HFA BAI 4.5 mcg/day |
| Name | Type | Description |
|---|---|---|
| Tiotropium HFA BAI 4.5 mcg | DRUG | - |
| Tiotropium HFA BAI 9.0 mcg | DRUG | - |
| SPIRIVA® HandiHaler® 18 mcg/day | DRUG | - |
| Spiriva® Respimat® 5 mcg/day | DRUG | - |
Inclusion Criteria: 1. Written informed consent signed and dated by the subject before conducting any study related procedure 2. Male or female subjects 40 -80 years of age, as of the Screening Visit 3. Diagnosis of COPD as defined by the GOLD (Global Initiative for Chronic Obstructive Lung Disease...