Trial Outcomes & Findings for Effect of Inhaled Fentanyl on Dyspnea and Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00974220)

Results Overview

The 10-point Borg scale ranges from 0 "nothing at all" to 10 "maximal/extremely strong" and was used to rate the intensity of dyspnea during exercise; therefore, a decrease in this rating signifies an improvement. Dyspnea intensity was assessed at the highest equivalent standardized time achieved in both post-treatment constant work rate cycle exercise tests.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

10-minutes post-treatment

Results posted on

2019-07-12

Participant Flow

Recruitment took place between February and October 2010. Subjects were recruited from respiratory outpatient clinics and from a database of subjects who had previously taken part in research studies in COPD.

No enrolled subjects were excluded prior to group assignment. 7 subjects were assigned a treatment order of fentanyl-placebo (2 were withdrawn after period 1) and 9 subjects were assigned a treatment order of placebo-fentanyl (2 were withdrawn after period 1). Therefore, there was complete data from 12 subjects.

Participant milestones

Participant milestones
Measure	Placebo - Fentanyl (Order) nebulized 0.9% saline placebo in period 1, nebulized fentanyl citrate 50mcg in period 2	Fentanyl - Placebo (Order) nebulized fentanyl citrate (50 mcg) in period 1, nebulized 0.9% saline placebo in period 2
Treatment Period 1 STARTED	9	7
Treatment Period 1 COMPLETED	7	5
Treatment Period 1 NOT COMPLETED	2	2
Treatment Period 2 STARTED	7	5
Treatment Period 2 COMPLETED	7	5
Treatment Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo - Fentanyl (Order) nebulized 0.9% saline placebo in period 1, nebulized fentanyl citrate 50mcg in period 2	Fentanyl - Placebo (Order) nebulized fentanyl citrate (50 mcg) in period 1, nebulized 0.9% saline placebo in period 2
Treatment Period 1 Adverse Event	2	1
Treatment Period 1 noncompliant subjects	0	1

Baseline Characteristics

Effect of Inhaled Fentanyl on Dyspnea and Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo - Fentanyl (Order) n=9 Participants nebulized saline placebo in period 1, nebulized fentanyl citrate in period 2.	Fentanyl - Placebo (Order) n=7 Participants nebulized fentanyl citrate in period 1, nebulized saline placebo in period 2.	Total n=16 Participants Total of all reporting groups
Age, Continuous	69 years STANDARD_DEVIATION 8 • n=93 Participants	66 years STANDARD_DEVIATION 10 • n=4 Participants	68 years STANDARD_DEVIATION 9 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
Region of Enrollment Canada	9 participants n=93 Participants	7 participants n=4 Participants	16 participants n=27 Participants

PRIMARY outcome

Timeframe: 10-minutes post-treatment

Population: Subjects who completed both treatment arms of the crossover study were included in the primary analysis.

The 10-point Borg scale ranges from 0 "nothing at all" to 10 "maximal/extremely strong" and was used to rate the intensity of dyspnea during exercise; therefore, a decrease in this rating signifies an improvement. Dyspnea intensity was assessed at the highest equivalent standardized time achieved in both post-treatment constant work rate cycle exercise tests.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants nebulized 0.9% saline placebo	Fentanyl n=12 Participants nebulized fentanyl citrate (50 mcg)
Dyspnea Intensity Measured by the 10-point Borg Scale During Cycle Exercise	2.6 units on a scale Standard Error 0.5	2.0 units on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: 10-minutes post-treatment

Population: Subjects completing both treatment arms were included in this analysis

Constant workrate cycle endurance during tests at 75% of the peak incremental workrate

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants nebulized 0.9% saline placebo	Fentanyl n=12 Participants nebulized fentanyl citrate (50 mcg)
Cycle Exercise Endurance Time	6.04 minutes Standard Error 0.56	7.34 minutes Standard Error 0.70

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Fentanyl

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=16 participants at risk nebulized 0.9% saline placebo	Fentanyl n=16 participants at risk nebulized fentanyl citrate (50 mcg)
Nervous system disorders lightheadedness, dizziness and mild nausea	6.2% 1/16 • Number of events 1 • During visit, with appropriate follow-up to resolution of adverse event	6.2% 1/16 • Number of events 1 • During visit, with appropriate follow-up to resolution of adverse event
Respiratory, thoracic and mediastinal disorders severe dyspnea	6.2% 1/16 • Number of events 1 • During visit, with appropriate follow-up to resolution of adverse event	0.00% 0/16 • During visit, with appropriate follow-up to resolution of adverse event

Additional Information

Dr. Denis O'Donnell

Queen's University, Kingston, ON, Canada

Phone: 1-613-548-2339

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place