Trial Outcomes & Findings for Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea (NCT NCT01832402)

Last Updated: 2023-06-08

Results Overview

Our primary outcome was dyspnea intensity "now" using a dyspnea numeric rating scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference of dyspnea numeric rating scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

1.5 to 2 hours on a Single visit

Results posted on

2023-06-08

Participant Flow

Adult participants (age\>18) with an active diagnosis of cancer were recruited between 6/2013 and 3/2015 from the Supportive Care Center outpatient clinic of MD Anderson Cancer Center who satisfied the inclusion and exclusion criteria.

Participant milestones

Participant milestones
Measure	Intervention Group (Fentanyl Pectin Nasal Spray) Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.	Controlled Group (Placebo) Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.
Overall Study STARTED	19	16
Overall Study Received Allocated Medication	12	12
Overall Study Completed Study With Correct Dose	10	9
Overall Study Completed Study With Incorrect Dose	2	3
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Group (Fentanyl Pectin Nasal Spray) Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.	Controlled Group (Placebo) Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	3	3
Overall Study Declining Performance status	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group (Fentanyl Pectin Nasal Spray) n=12 Participants Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.	Controlled Group (Placebo) n=12 Participants Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.	Total n=24 Participants Total of all reporting groups
Age, Continuous	51.5 Years n=5 Participants	53.3 Years n=7 Participants	52.4 Years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Education High School or less	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Education College	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Education Advanced Degree	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Cancer Type GastroIntestinal Cancer	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Cancer Type Breast Cancer	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Cancer Type Lung Cancer	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Cancer Type Genitourinary Cancer	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Cancer Type Gynecologic Cancer	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Cancer Type Hematologic	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Cancer Type Others	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Cancer Stage Metastatic Stage	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Cancer Stage Localized/Locally advanced	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Comorbidity Asthma	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Comorbidity COPD	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Comorbidity Heart Failure	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1.5 to 2 hours on a Single visit

Outcome measures

Outcome measures
Measure	Intervention Group (Fentanyl Pectin Nasal Spray) n=12 Participants Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.	Controlled Group (Placebo) n=12 Participants Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.
Dyspnea Numeric Rating Scale Mean difference between 1st and 2nd walk tests	-2.0 score on a scale Interval -3.5 to -0.6	-1.7 score on a scale Interval -3.3 to -0.1
Dyspnea Numeric Rating Scale Mean difference between 1st and 3rd walk tests	-2.3 score on a scale Interval -4.0 to -0.7	-2.5 score on a scale Interval -4.2 to -0.9

SECONDARY outcome

Timeframe: 1.5 to 2 hours on a Single visit

Assessed dyspnea using the modified Dyspnea Borg Scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference of modified Dyspnea Borg scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests.

Outcome measures

Outcome measures
Measure	Intervention Group (Fentanyl Pectin Nasal Spray) n=12 Participants Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.	Controlled Group (Placebo) n=12 Participants Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.
Dyspnea Borg Scale Mean difference between 1st and 2nd walk tests	-1.8 score on a scale Interval -3.1 to -0.4	-1.7 score on a scale Interval -3.3 to -0.1
Dyspnea Borg Scale Mean difference between 1st and 3rd walk tests	-1.7 score on a scale Interval -3.5 to 0.0	-2.4 score on a scale Interval -4.2 to -0.6

SECONDARY outcome

Timeframe: 1.5 to 2 hours on a Single visit

Compared the mean difference of distance between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests.

Outcome measures

Outcome measures
Measure	Intervention Group (Fentanyl Pectin Nasal Spray) n=12 Participants Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.	Controlled Group (Placebo) n=12 Participants Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.
Walk Distance at 6 Minutes Mean difference between 1st and 2nd walk tests	23.8 meters Interval 1.3 to 46.2	16.3 meters Interval -8.6 to 41.3
Walk Distance at 6 Minutes Mean difference between 1st and 3rd walk tests	23.3 meters Interval -1.7 to 48.2	14.6 meters Interval -11.0 to 40.3

Adverse Events

Interventional (Fentanyl Pectin Nasal Spray) Second Walk Test

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control (Placebo), Second Walk Test

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Interventional (Fentanyl Pectin Nasal Spray),Third Walk Test

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Control (Placebo), Third Walk Test

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Interventional (Fentanyl Pectin Nasal Spray) Second Walk Test n=12 participants at risk Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.	Control (Placebo), Second Walk Test n=12 participants at risk Received similar number of Placebo Spray 20 minutes before 2nd 6 minute walk tests.	Interventional (Fentanyl Pectin Nasal Spray),Third Walk Test n=12 participants at risk Received Fentanyl Pectin Nasal Spray 20 minutes before 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.	Control (Placebo), Third Walk Test n=12 participants at risk Received similar Placebo Spray 20 minutes before 3rd 6 minute walk tests.
Gastrointestinal disorders Nausea	0.00% 0/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	0.00% 0/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	16.7% 2/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	0.00% 0/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).
Nervous system disorders Dizziness	16.7% 2/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	16.7% 2/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	41.7% 5/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	8.3% 1/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).
Nervous system disorders Drowsiness	8.3% 1/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	16.7% 2/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	8.3% 1/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	41.7% 5/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).
Respiratory, thoracic and mediastinal disorders Stuffy Nose	0.00% 0/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	16.7% 2/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	0.00% 0/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	0.00% 0/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).
Respiratory, thoracic and mediastinal disorders Nose Dryness	0.00% 0/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	16.7% 2/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	0.00% 0/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	16.7% 2/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).
Respiratory, thoracic and mediastinal disorders Cough	8.3% 1/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	0.00% 0/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	0.00% 0/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	8.3% 1/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	8.3% 1/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	0.00% 0/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).	0.00% 0/12 • Baseline, up to 2 hours in one single visit Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).

Additional Information

David Hui, MD/ Associate Professor, Palliative Care Medicine

UT MD Anderson Cancer Center

Phone: 713-792-6258

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place