NCT05531422

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Consenting patients who met inclusion and exclusion criteria were allowed to enter the study. The medication for background pain during screening were maintained until the end of the study. Each patient would be treated and observed for 6 episodes of targeted BTcP. Patients were randomly assigned to 1 of the 6 prespecified dose sequences which were established by a computer-generated schedule of active drug and placebo in a 4:2 ratio. All patients and personnel involved with the study (including investigators and investigation site personnel) were blinded to the medication codes.

Conditions

• Breakthrough Cancer Pain

Interventions

Type	Name	Description
DRUG	Inhaled fentanyl aerosol	Participants were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with inhaled fentanyl aerosol (with a starting dose of 25 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×25 µg) and 2 BTP episodes with placebo(0 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×0µg) in a random sequence.
DRUG	Placebo	Participants were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with inhaled fentanyl aerosol (with a starting dose of 25 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×25 µg) and 2 BTP episodes with placebo(0 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×0µg) in a random sequence.

Timeline

• Start date: 2021-10-20
• Primary completion: 2023-03-15
• Completion: 2023-04-27
• First posted: 2022-09-08
• Last updated: 2024-06-12

Locations

1 site across 1 country: China