Trial Outcomes & Findings for Role of Endorphins in Perception of Dyspnea With Resistive Loading in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00958919)

Results Overview

The average of all ratings for the intensity of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with naloxone and 10 ratings during 10 minutes of RLB with normal saline, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 154 ratings for naloxone and for normal saline. Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by "No Intensity" and at the top by "Greatest Intensity".

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)

Results posted on

2013-04-11

Participant Flow

March 2009 - June 2010; medical center

17 subjects recruited; 3 subjects excluded (2 did not meet inclusion criteria; 1 refused participation after signing consent).

Participant milestones

Participant milestones
Measure	Normal Saline First, Then Naloxone Intravenous saline (25 ml) in first intervention period and intravenous Naloxone (10mg/25 ml) in second intervention period.	Naloxone First, Then Normal Saline Intravenous Naloxone (10mg/25 ml)in first intervention period and intravenous saline (25 ml) in second intervention period.
First Intervention STARTED	7	7
First Intervention COMPLETED	7	7
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	7	7
Second Intervention COMPLETED	7	7
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Endorphins in Perception of Dyspnea With Resistive Loading in Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=14 Participants Includes groups randomized to receive saline first and Naxolone first.
Age Continuous	64 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)

Population: Total number of subjects completing both periods of the study.

The average of all ratings for the intensity of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with naloxone and 10 ratings during 10 minutes of RLB with normal saline, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 154 ratings for naloxone and for normal saline. Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by "No Intensity" and at the top by "Greatest Intensity".

Outcome measures

Outcome measures
Measure	Normal Saline n=14 Participants Intravenous saline (25 ml)	Naloxone n=14 Participants Intravenous Naloxone (10mg/25ml)
Intensity of Breathlessness	77 units on a scale Standard Deviation 21	83 units on a scale Standard Deviation 18

PRIMARY outcome

Timeframe: At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)

Population: Total number of subjects completing both periods of the study.

The average of all ratings for the unpleasantness of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with naloxone and 10 ratings during 10 minutes of RLB with normal saline, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 154 ratings for naloxone and for normal saline. Subject rating of intensity of unpleasantness was obtained during RLB on a 100 mm Visual Analog Scale anchored at the bottom by "No Unpleasantness" and at the top by "Greatest Unpleasantness".

Outcome measures

Outcome measures
Measure	Normal Saline n=14 Participants Intravenous saline (25 ml)	Naloxone n=14 Participants Intravenous Naloxone (10mg/25ml)
Unpleasantness of Breathlessness	77 units on a scale Standard Deviation 19	81 units on a scale Standard Deviation 20

SECONDARY outcome

Timeframe: Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)

Population: Total number of subjects completing both periods of the study.

Length of time that subjects were able to continue Resistive Load Breathing

Outcome measures

Outcome measures
Measure	Normal Saline n=14 Participants Intravenous saline (25 ml)	Naloxone n=14 Participants Intravenous Naloxone (10mg/25ml)
Endurance Time	13.9 minutes Standard Deviation 4.7	12.5 minutes Standard Deviation 5.4

SECONDARY outcome

Timeframe: Baseline and at the end of Resistance Load Breathing during either Period 1 (Day 3 or 4) or Period 2 (Day 5, 6 or 7) depending on randomization

Population: Total number of subjects completing period with Naloxone intervention.

Change in serum levels of beta-endorphin immunoreactivity measured in pmol/L in subjects receiving Naloxone

Outcome measures

Outcome measures
Measure	Normal Saline n=14 Participants Intravenous saline (25 ml)	Naloxone n=14 Participants Intravenous Naloxone (10mg/25ml)
Change in Level of B-endorphin Immunoreactivity During Naloxone Intervention	6.0 pmol/L Standard Deviation 1.5	18.5 pmol/L Standard Deviation 3.4

SECONDARY outcome

Timeframe: Baseline and at the end of Resistance Load Breathing during either Period 1 (Day 3 or 4) or Period 2 (Day 5, 6 or 7) depending on randomization

Population: Total number of subjects completing period with saline intervention.

Change in serum levels of beta-endorphin immunoreactivity measured in pmol/L in subjects receiving Saline

Outcome measures

Outcome measures
Measure	Normal Saline n=14 Participants Intravenous saline (25 ml)	Naloxone n=14 Participants Intravenous Naloxone (10mg/25ml)
Change in Level of B-endorphin Immunoreactivity During Saline Intervention	6.7 pmol/L Standard Deviation 1.4	13.4 pmol/L Standard Deviation 2.5

Adverse Events

Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Naloxone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Donald A. Mahler, M.D.

Dartmouth-Hitchcock

Phone: 603 650-5533

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place