Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP

Summary

Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. This is a phase IIa dose-response and safety study of inhaled fentanyl aerosol (25µg/dose) in Chinese patients with breakthrough cancer pain.

Timeline

Start

2021-10-20

Primary completion

2023-03-15

Completion

2023-04-27

Outcome

Met primary endpoint

paper The mean SPID30 was -97.4 ± 48.43 for fentanyl inhalant-treated episodes, and -64.6 ± 40.25 for placebo-treated episodes (p < 0.001). PMID 39244530 ↗

paper Treatment with fentanyl inhalant was shown to be a promising therapeutic option for BTcP, with significant pain relief starting very soon after dosing. PMID 39244530 ↗

Publications

• Lin R, Song B, Li N, Rong B, Bai J, Liu Y, Wang W, Liu A, Luo S, Liu B, Cheng P, Wu Y, Li Y, Yu X, Liu X, Dai X, Li X, Liu D, Wang J, Huang Y. Efficacy and safety of fentanyl inhalant for the treatment of breakthrough cancer pain: a multicenter, randomized, double-blind, placebo-controlled trial. BMC Palliat Care. 2024 Sep 7;23(1):222. doi: 10.1186/s12904-024-01554-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fentanyl	Other / unclassified	25 ug	Inhaled

Indications

No indication recorded.