Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tiotropium HFA BAI · 1 trial · 1 indication
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 5 | PHASE3 | Depemokimab |
| Sanofi SA Sponsored ADR | SNY | 7 | PHASE3 | Itepekimab |
| AstraZeneca PLC | AZN | 14 | PHASE3 | Tezepelumab |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Alpha-1 MP |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07275315 dose 1 |
| Merck & Co., Inc. | MRK | 2 | PHASE2 | Frespaciguat |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE3 | 611 |
| Generate Biomedicines, Inc. | GENB | 1 | PHASE1 | GB-0895 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | Treprostinil |
| Pulmonx Corp. | LUNG | 3 | - | Undisclosed |
| Baxter International Inc. | BAX | 1 | N/A | Undisclosed |
| Catalyst Pharmaceuticals, Inc. | CPRX | 1 | EARLY_PHASE1 | Undisclosed |
Tiotropium HFA BAI is an investigational small molecule being developed for the treatment of chronic obstructive pulmonary disease (COPD). It is administered via a breath-actuated inhaler (BAI) formulation. The drug is currently in Phase 1 clinical development and is not yet approved for any use.
Tiotropium HFA BAI is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker TEVA. The drug is in Phase 1 clinical development for the treatment of COPD.
Tiotropium HFA BAI is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed to evaluate its pharmacokinetics in subjects with COPD.
Tiotropium HFA BAI has one completed clinical trial, identified as NCT01785433. This Phase 1 study, titled 'To Compare the Pharmacokinetics of Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease (COPD),' enrolled 36 participants in Germany. The trial was controlled and randomized, though not double-blind.
Tiotropium HFA BAI is a formulation of tiotropium delivered via a hydrofluoroalkane (HFA) propellant in a breath-actuated inhaler (BAI). It is being developed by Teva Pharmaceutical Industries for COPD. The drug is in Phase 1 development and is not yet approved.