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FP-025 in mild HDM-allergic asthma
NCT03858686Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2018
- Primary completion
- Dec 2022
- Countries
- 1
- Sponsor
- Foresee Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- aderamastat
- Conditions
- allergic asthma
01
Overview
Phase 2, randomised, double-blind trial in allergic asthma comparing FP-025 Sequence with Placebo Sequence (2 arms). Primary endpoint: Late Asthmatic Response (FEV1 AUC 3-8h) at Day 11. Started Jul 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
FP-025 Sequence
FP-025 in Period 1, Placebo in Period 2
Placebo Sequence
Placebo in Period 1, FP-025 in Period 2
03
Who it enrols
Adults 18-55 with stable, mild HDM-allergic asthma, FEV1 >= 70%, and blood eosinophils >= 150 cells/uL. Excludes smokers and those on maintenance asthma therapy.
04
Endpoints
Primary
Late Asthmatic Response (FEV1 AUC 3-8h)
Secondary
Early Asthmatic Response (FEV1 AUC 0-3h)
Maximal Percent Fall in FEV1 (0-3h)
Joint HDM-induced Airway Response (FEV1 AUC 0-8h)
Provocative Concentration causing 20% fall in FEV1
Impulse Oscillometry Resistance at 5Hz (AUC 3-8h)
Blood Eosinophil Count
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