Efficacy and safety of fentanyl inhalant for the treatment of breakthrough cancer pain: a multicenter, randomized, double-blind, placebo-controlled trial

• Published in: BMC palliative care 2024-09, Vol.23 (1), p.222-9, Article 222
• Main Authors: Lin, Rongbo, Song, Binbin, Li, Na, Rong, Biaoxue, Bai, Jinghui, Liu, Yong, Wang, Wei, Liu, Anwen, Luo, Suxia, Liu, Bo, Cheng, Peng, Wu, Yani, Li, Yujie, Yu, Xiaohui, Liu, Xueying, Dai, Xiangrong, Li, Xiaoyi, Liu, Dongying, Wang, Jian, Huang, Yan
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Adult; Aerosols; Aged; Aged, 80 and over; Analgesics, Opioid - administration & dosage; Analgesics, Opioid - therapeutic use; Bioavailability; Breakthrough cancer pain; Breakthrough Pain - drug therapy; Breakthrough Pain - etiology; Cancer; Cancer pain; Cancer Pain - drug therapy; Cancer therapies; Care and treatment; Central nervous system depressants; Clinical trials; Cross-Over Studies; Double-Blind Method; Drug dosages; Drug therapy; Female; Fentanyl; Fentanyl - administration & dosage; Fentanyl - pharmacology; Fentanyl - therapeutic use; Humans; Inhaled fentanyl; Male; Medical laboratories; Middle Aged; Morphine; Narcotics; Oxygen saturation; Pain; Pain Measurement - methods; Patients; Pharmacokinetics; Rapid-onset opioid; Treatment Outcome; Vital signs
• ISSN: 1472-684X; 1472-684X
• DOI: 10.1186/s12904-024-01554-9

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. 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). 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