Efficacy and Safety of Fentanyl Inhalant for the Treatment of Breakthrough Cancer Pain: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Overview

Journal BMC Palliat Care

Publisher Biomed Central

Specialty Critical Care

Date 2024 Sep 7

PMID 39244530

Authors

Rongbo Lin

Binbin Song

Na Li

Biaoxue Rong

Jinghui Bai

Yong Liu

Wei Wang

Anwen Liu

Suxia Luo

Bo Liu

Peng Cheng

Yani Wu

Yujie Li

Xiaohui Yu

Xueying Liu

Xiangrong Dai

Xiaoyi Li

Dongying Liu

Jian Wang

Yan Huang

Affiliations

Soon will be listed here.

Abstract

Background: Breakthrough cancer pain (BTcP) has a negative impact on patients' quality of life, general activities, and is related to worse clinical outcomes. Fentanyl inhalant is a hand-held combination drug-device delivery system providing rapid, multi-dose (25μg/dose) administration of fentanyl via inhalation of a thermally generated aerosol. This multicenter, randomized, placebo-controlled, multiple-crossover, double-blind study evaluated the efficacy, safety, and tolerability of fentanyl inhalant in treating BTcP in opioid-tolerant patients.

Methods: The trial was conducted in opioid-tolerant cancer patients with 1 ~ 4 BTcP outbursts per day. Each patient was treated and observed for 6 episodes of BTcP (4 with fentanyl inhalant, 2 with placebo). During each episode of targeted BTcP, patients were allowed up to six inhalations, with an interval of at least 4 min between doses. Primary outcome was the time-weighted sum of PID (pain intensity difference) scores at 30 min (SPID30).

Results: A total of 335 BTcP episodes in 59 patients were treated. 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). Significant differences in PID for episodes treated with fentanyl inhalant versus placebo was seen as early as 4 min and maintained for up to 60 min. The percentage of episodes reported PI (pain intensity) scores ≤ 3, a ≥ 33% or ≥ 50% reduction in PI scores at 30 min, PR30 (pain relief scores at 30 min) and SPID60 favored fentanyl inhalant over placebo. Only 4.4% of BTcP episodes required rescue medication in fentanyl inhalant group. Most AEs were of mild or moderate severity and typical of opioid drugs.

Conclusion: Treatment with fentanyl inhalant was shown to be a promising therapeutic option for BTcP, with significant pain relief starting very soon after dosing. Confirmation of effectiveness requires a larger phase III trial.

Trial Registration: ClinicalTrials.gov: NCT05531422 registered on 6 September 2022 after major amendment, NCT04713189 registered on 14 January 2021.

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