Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

June 11, 2013

Primary Completion Date

November 25, 2019

Study Completion Date

November 25, 2019

Conditions
Advanced Cancers
Interventions
DRUG

Fentanyl Pectin Nasal Spray

Fentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.

DRUG

Placebo Nasal Spray

Placebo nasal spray administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.

OTHER

Walk Test

Walk test administered before first dose of drug/placebo nasal spray. Participant will rest for 30 minutes after walk test. Drug/placebo nasal spray administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. Drug/placebo nasal spray administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes.

BEHAVIORAL

Questionnaires

Questionnaires completed at baseline, before each walk test, and at end of final walk test.

BEHAVIORAL

Mental Ability Tests

Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Depomed

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT01832402 - Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea | Biotech Hunter | Biotech Hunter