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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00801684 | ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD | PHASE2 | COMPLETED | 24 | — | — | Feb 1, 2009 | Jul 1, 2009 | Aug 19, 2011 | 1 | United States |
Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. The dosing formulations were as follows: Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate) FEV1 (L)was measured at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Represents Dose A in the Dosing Sequence assignments. |
| TrIP-2D (100mcg) | EXPERIMENTAL | Represents Dose B |
| TrIP-2SS (100mcg) | EXPERIMENTAL | Represents Dose C |
| TrIP-2D (400mcg) | EXPERIMENTAL | Represents Dose D |
| TrIP-2SS (100mcg) + Foradil (12mcg) | EXPERIMENTAL | Represents Dose E. All subjects received Dose E as their final (5th) dose, after completing their initial 4 single doses according to their sequence assignment. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Supplied as an empty size-2 capsule and administered as a single dose via C2S inhaler. |
| TrIP-2D | DRUG | Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. |
| TrIP-2SS | DRUG | Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. |
| TrIP-2SS + Foradil | DRUG | Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), plus foradil (12 mcg formoterol fumarate) supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. |
Inclusion Criteria: * Male or female COPD subjects between the ages of 40 and 80 years * Body mass index between 18 and 35 * Medically healthy (other than COPD) * FEV1/FVC less than or equal to 0.70 * Current non-smoker or able to abstain from smoking for at least 8 hours postdose * Within the prev...