Trial Outcomes & Findings for Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea (NCT NCT02597478)
NCT ID: NCT02597478
Last Updated: 2021-02-09
Results Overview
The primary outcome was dyspnea intensity "now" using the modified Borg scale, which ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). We measured the change in modified dyspnea Borg scale (0-10) between the first and second shuttle walk tests. This scale has been validated in multiple studies, with a minimal clinically significant difference of 1 point.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
50 participants
Primary outcome timeframe
Before and after the first and second shuttle walk tests
Results posted on
2021-02-09
Participant Flow
Adult participants (age\>18) with an active diagnosis of cancer were recruited between 1/2016 and 10/2018 from the Supportive Care and Thoracic Medical Oncology outpatient clinics at MD Anderson Cancer Center who met the inclusion and exclusion criteria.
A total of 50 participants enrolled but 34 patients were randomized to start the study. 13 became symptomatic while on wait list and could not proceed, 2 participants died, and 1 had screen failure before participants were randomized.
Participant milestones
| Measure |
Intervention Group (High Dose Fentanyl Sublingual Spray)
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 35-45% of morphine equivalent daily dose.
|
Controlled Group (Low Dose Fentanyl Sublingual Spray)
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 15-20% of morphine equivalent daily dose.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
18
|
|
Overall Study
COMPLETED
|
13
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Intervention Group (High Dose Fentanyl Sublingual Spray)
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 35-45% of morphine equivalent daily dose.
|
Controlled Group (Low Dose Fentanyl Sublingual Spray)
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 15-20% of morphine equivalent daily dose.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Change of opioid dose
|
1
|
0
|
|
Overall Study
Insufficient exertional dyspnea
|
0
|
1
|
Baseline Characteristics
Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea
Baseline characteristics by cohort
| Measure |
Intervention Group (High Dose Fentanyl Sublingual Spray)
n=13 Participants
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 35-45% of morphine equivalent daily dose.
|
Controlled Group (Low Dose Fentanyl Sublingual Spray)
n=17 Participants
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 15-20% of morphine equivalent daily dose.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 16 • n=99 Participants
|
51 years
STANDARD_DEVIATION 10 • n=107 Participants
|
52 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
17 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Education
High school or less
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Education
College
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Education
Advanced degree
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Cancer Type
Breast
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Cancer Type
Genitourinary
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Cancer Type
Gastrointestinal
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Cancer Type
Gynecological
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Cancer Type
Head and Neck
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Cancer Type
Respiratory
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Cancer Type
Others
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Cancer Stage
Metastatic or recurrent
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Cancer Stage
Locally advanced
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Cancer Stage
Localized
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Before and after the first and second shuttle walk testsThe primary outcome was dyspnea intensity "now" using the modified Borg scale, which ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). We measured the change in modified dyspnea Borg scale (0-10) between the first and second shuttle walk tests. This scale has been validated in multiple studies, with a minimal clinically significant difference of 1 point.
Outcome measures
| Measure |
Intervention Group (High Dose Fentanyl Sublingual Spray)
n=13 Participants
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 35-45% of morphine equivalent daily dose.
|
Controlled Group (Low Dose Fentanyl Sublingual Spray)
n=17 Participants
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 15-20% of morphine equivalent daily dose.
|
|---|---|---|
|
Modified Dyspnea Borg Scale (Dyspnea Intensity)
|
-1.4 score on a scale
Interval -2.4 to -0.5
|
-0.5 score on a scale
Interval -1.3 to 0.3
|
SECONDARY outcome
Timeframe: Before and after the first and second shuttle walk testsThe modified Borg scale (dyspnea unpleasantness), which ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). We measured the change in modified dyspnea Borg scale (0-10) between the first and second shuttle walk tests.
Outcome measures
| Measure |
Intervention Group (High Dose Fentanyl Sublingual Spray)
n=13 Participants
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 35-45% of morphine equivalent daily dose.
|
Controlled Group (Low Dose Fentanyl Sublingual Spray)
n=17 Participants
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 15-20% of morphine equivalent daily dose.
|
|---|---|---|
|
Modified Dyspnea Borg Scale (Dyspnea Unpleasantness)
|
-1.0 score on a scale
Standard Deviation 1.8
|
-0.6 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: After the first shuttle walk test and after the second shuttle walk testWe measured the difference in walk distance (in meters) between the first and second shuttle walk tests.
Outcome measures
| Measure |
Intervention Group (High Dose Fentanyl Sublingual Spray)
n=13 Participants
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 35-45% of morphine equivalent daily dose.
|
Controlled Group (Low Dose Fentanyl Sublingual Spray)
n=17 Participants
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 15-20% of morphine equivalent daily dose.
|
|---|---|---|
|
Walk Distance
|
43.7 meters
Interval 25.6 to 61.8
|
24.2 meters
Interval 5.8 to 42.6
|
SECONDARY outcome
Timeframe: After the first shuttle walk test and after the second shuttle walk testWe measured the difference in walk time (in minutes) between the first and second shuttle walk tests.
Outcome measures
| Measure |
Intervention Group (High Dose Fentanyl Sublingual Spray)
n=13 Participants
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 35-45% of morphine equivalent daily dose.
|
Controlled Group (Low Dose Fentanyl Sublingual Spray)
n=17 Participants
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 15-20% of morphine equivalent daily dose.
|
|---|---|---|
|
Walk Time
|
0.5 minutes
Interval 0.3 to 0.7
|
0.3 minutes
Interval 0.18 to 0.5
|
SECONDARY outcome
Timeframe: Before and after the first and second shuttle walk testsThe fatigue modified Borg scale, which ranges from 0 ("none") to 10 ("worst"). We measured the change in modified fatigue Borg scale (0-10) between the first and second shuttle walk tests.
Outcome measures
| Measure |
Intervention Group (High Dose Fentanyl Sublingual Spray)
n=13 Participants
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 35-45% of morphine equivalent daily dose.
|
Controlled Group (Low Dose Fentanyl Sublingual Spray)
n=17 Participants
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 15-20% of morphine equivalent daily dose.
|
|---|---|---|
|
Fatigue Modified Borg Score
|
-1.0 score on a scale
Standard Deviation 2.8
|
0.2 score on a scale
Standard Deviation 1.6
|
Adverse Events
Intervention Group (High Dose Fentanyl Sublingual Spray)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Controlled Group (Low Dose Fentanyl Sublingual Spray)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group (High Dose Fentanyl Sublingual Spray)
n=13 participants at risk
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 35-45% of morphine equivalent daily dose.
|
Controlled Group (Low Dose Fentanyl Sublingual Spray)
n=17 participants at risk
Received Fentanyl sublingual spray 10 minutes before performing second shuttle walk test, dose was 15-20% of morphine equivalent daily dose.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • immediately before drug administration and immediately after the second walk test (approximately 20 min later)
|
29.4%
5/17 • immediately before drug administration and immediately after the second walk test (approximately 20 min later)
|
|
Nervous system disorders
Drowsiness
|
15.4%
2/13 • immediately before drug administration and immediately after the second walk test (approximately 20 min later)
|
5.9%
1/17 • immediately before drug administration and immediately after the second walk test (approximately 20 min later)
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
0.00%
0/13 • immediately before drug administration and immediately after the second walk test (approximately 20 min later)
|
5.9%
1/17 • immediately before drug administration and immediately after the second walk test (approximately 20 min 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