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

NCT04713189 | Unknown Phase 1

• 1 other identifier: ZK05
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

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

  During the stage I, at each episode of breakthrough pain, 30 minutes after first dose of study drug.

Secondary Outcomes (5)

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

  During the stage I, at each episode of breakthrough pain, 60 minutes after first dose of study drug.

• SPID60

  During the stage I, at each episode of breakthrough pain, 60 minutes after first dose of study drug.

• Percentage of episodes with NRS≤3

  Through study completion, an average of 4 days

• Percentage of episodes with at least 33% and 50%decrease in pain

  Through study completion, an average of 4 days

• Rescue medication usage

  Through study completion, an average of 4 days

Other Outcomes (1)

• device performance

  through study completion, an average of 4 days

Study Arms (2)

Inhaled fentanyl aerosol

EXPERIMENTAL

Participants in the stage I were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with inhale 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: Inhaled fentanyl aerosol

Placebo

EXPERIMENTAL

Participants in the stage I 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 in the stage I were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with inhale 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 in the stage Ⅰ 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. I

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 to 75years, inclusive.
• Subjects must be diagnosed with cancer.
• Subjects must be opioid-tolerant : taking oral morphine more than 60mg and less than 1000mg,or taking other equivalent potency opioids of analgesic doses in one weeks or longer.
• Subjects must experience persistent pain associated with cancer, and the pain score assessed by NRS should be \<4 within 24hour before screening.
• The breakthrough cancer pain score should be ≥4 assessed by NRS.
• In the past 7 days, the subject must experience an average of 1 to 4 episodes of breakthrough cancer pain per day, and use 5 mg immediate release morphine at least or equivalent short-acting opioids (e.g., oxycodone, hydrocodone ketones or codeine) to control this pain.
• ECOG status of 0 to 2.
• Life expectancy should be longer than 3 months.
• Subjects must consent to take adequate contraception within 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:

• Allergies, or a history of drug allergies to fentanyl.
• On intrathecal or epidural opioids.
• HGB \< 80 g/L, NEUT ≤1.5 × 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).
• Hepatitis B surface antigen and hepatitis C surface antibody positive. Human T Lymphotropic Virus Type I Positive. HIV positive.
• Gastrointestinal bleeding or diarrhea presently.
• Requirement of continuous paracentesis.
• 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

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 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 19, 2021
• Study Start: March 15, 2021
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01