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

NCT05531422 | Completed Phase 2

• 1 other identifier: ZK06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breakthrough Cancer Pain

Outcome Measures

Primary Outcomes (1)

• SPID30

  Weighted sum of pain intensity difference at post dose 30 minutes.Pain intensity at each breakthrough pain (BTP) episode at 0 ,4,8,12,16,20 and 30 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is "worst possible pain". PID30 is calculated as the difference in pain intensity from time 0 to 30 minutes. A positive value is a decrease (improvement) of the pain.SPID30=PID4\*4+PID8\*4+PID12\*4+PID16\*4+PID20\*4+PID30\*10

  at each episode of breakthrough pain, 30 minutes after first dose of study drug.

Secondary Outcomes (1)

• Pain intensity at 0, 4,8,12,16,20,30 and 60 minutes post-dose

  at each episode of breakthrough pain, 60 minutes after first dose of study drug.

Study Arms (2)

Inhaled fentanyl aerosol

EXPERIMENTAL

Participants were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with Inhaled fentanyl aerosol (25 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×25µg) in a random sequence

Drug: Inhaled fentanyl aerosol

Placebo

PLACEBO COMPARATOR

Participants were randomized to 6 BTP episodes, in which 2 BTP episodes were treated with placebo (0 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×0µg) in a random sequence

Drug: Placebo

Interventions

Inhaled fentanyl aerosol DRUG

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.

Inhaled fentanyl aerosol

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years or above
• Subjects must be diagnosed with cancer.
• Subjects must experience persistent pain associated with cancer, and the pain score assessed by NRS should be \<4 within 1week before screening.
• In the past 7 days, the subject must experience an average of 1 to 4 episodes of breakthrough cancer pain per day,The breakthrough cancer pain score should be ≥4 assessed by NRS
• ECOG status of 0 to 2.
• Subjects must consent to take adequate contraception during the study and 1 months after the study. Women of childbearing potential must show negative in the pregnancy test before dosing.
• The subject must be able to understand the requirements of the study and provide a written informed consent.

You may not qualify if:

• History or suspected allergies to fentanyl.
• HGB \< 80 g/L, NEUT ≤1.0 × l09/L, PLT ≤50 × l09/L；ALT and AST higher than 3 times of ULN;total bilirubin and Cr higher than 1.5 times of ULN;PaO2 \<95%;FEV1/FVC\<70% and FEV1 accounted for less than 80% of the predicted value.
• Any uncontrolled disease (e.g., severe mental, neurological, infectious, cardiovascular, respiratory and other systemic diseases).
• Tumor infiltration to central nervous system.
• Subjects are not able to slef evaluate pain intensity using NRS
• Receive surgery in past 3 weeks
• Treatment with any form of radiotherapy winth 1week prior to study entry that could alter pain or response to pain medication.
• Taking monoamine oxidase inhibitors(MAOIs), CYP3A4 inhibitors or inducers within 14 days of the screening
• Participated in other clinical trials in past 1months.
• Pregnancy and breast-feeding women, women of childbearing age ready to conceive, and pregnancy test positive.
• Other conditions that may affect the informed consent, compliance with the protocol, study results and safety of the subject.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• 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.

  PMID: 39244530 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 8, 2022
• Study Start: October 20, 2021
• Primary Completion: March 15, 2023
• Study Completion: April 27, 2023
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)