Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response
Summary
This will be a randomized, double-blind, placebo-controlled study. The study will use a three-period, six-sequence, complete-block, cross-over study design to characterize two doses of inhaled TD-8236 compared to placebo in subjects with mild asthma and a known response to an allergen. Each of the three periods will be 14 days, followed by a washout period before the next period.
Timeline
- Start
- 2019-11-06
- Primary completion
- 2020-08-28
- Completion
- 2020-09-03
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs TD-8236 150 mcg; p = 0.881; Mean Difference (Final Values) -0.01 (95% CI -0.14 to 0.12); Mixed Models Analysis NCT04150341 ↗
registry analysis (superiority test); Placebo vs TD-8236 1500 mcg; p = 0.575; Mean Difference (Final Values) -0.04 (95% CI -0.17 to 0.1); Mixed Models Analysis NCT04150341 ↗
release “TD-8236 as a single agent did not meet the primary objective of the Phase 2a LAC study.” theravance.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TD-8236 | Unknown | — | Inhaled |