Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 4, 2016

Primary Completion Date

September 27, 2018

Study Completion Date

January 27, 2021

Conditions
Advanced Cancers
Interventions
DRUG

Fentanyl Sublingual Spray

"Low-dose Fentanyl Goup: 15-25% of the morphine equivalent daily dose (MEDD) sprayed into mouth and under tongue one hour after first Shuttle Walk Test.~High-Dose Fentanyl Group: 35-45% of the morphine equivalent daily dose (MEDD) sprayed into mouth and under tongue one hour after first Shuttle Walk Test."

PROCEDURE

Shuttle Walk Test

Participants walk back and forth between 2 cones in an indoor hallway for up to 12 minutes. After one hour Fentanyl Spray delivered, then second walk test performed.

BEHAVIORAL

Questionnaires

Questionnaire completed about any breathing problems or other symptoms participant may be having at baseline. End of study questionnaire asks which dose level of study drug participant thinks they received. Participant also completes a questionnaire about how study drug may have helped them and how satisfied they are with the study. It should take about 5 minutes to complete the questionnaire.

BEHAVIORAL

Mental Ability Tests

After each walk test, participant completes 4 tests of their mental abilities. It should take 15 minutes total to complete these tests.

BEHAVIORAL

Phone Call

Thirty days study visit participant called by study staff. This call should last about 10 minutes.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

INSYS Therapeutics Inc

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT02597478 - Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea | Biotech Hunter | Biotech Hunter