Trial Outcomes & Findings for Differentiating the Effects of Substance P and Beta-endorphin (NCT NCT01854177)
NCT ID: NCT01854177
Last Updated: 2018-10-30
Results Overview
Unpleasantness of breathlessness was reported each minute by the patient on a visual analog scale. The scale range is 0-10 where 0 = No breathlessness and 10 = Severe breathlessness. The measures were collected up to 20 minutes per visit and combined for a final score. Total minimum score = 0, total maximum score 200. Data is collected during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7) during which either Placebo or Aprepitant was administered. A high unpleasantness indicates that breathing difficulty feels very bad or terrifying regardless of whether the intensity is high or low
COMPLETED
NA
10 participants
Visit 2 (Approximately Day 3 where either Placebo or Aprepitant was administered).and Visit 3 (approximately Day 6 where either Placebo or Aprepitant was administered)
2018-10-30
Participant Flow
Participant milestones
| Measure |
Overall Study Population
Participants who consented and received both Aprepitant 125 mg taken orally and Placebo (Inert capsule taken orally) in random order 2-3 days apart.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Differentiating the Effects of Substance P and Beta-endorphin
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=9 Participants
Includes groups randomized to receive Aprepitant first and placebo
|
|---|---|
|
Age, Continuous
|
70.6 years
STANDARD_DEVIATION 6.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (Approximately Day 3 where either Placebo or Aprepitant was administered).and Visit 3 (approximately Day 6 where either Placebo or Aprepitant was administered)Population: One patient was excluded from analysis because there was a 28% difference in her post-bronchodilator FEV1 between visits 2 and 3.
Unpleasantness of breathlessness was reported each minute by the patient on a visual analog scale. The scale range is 0-10 where 0 = No breathlessness and 10 = Severe breathlessness. The measures were collected up to 20 minutes per visit and combined for a final score. Total minimum score = 0, total maximum score 200. Data is collected during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7) during which either Placebo or Aprepitant was administered. A high unpleasantness indicates that breathing difficulty feels very bad or terrifying regardless of whether the intensity is high or low
Outcome measures
| Measure |
Aprepitant
n=9 Participants
aprepitant 125 mg taken orally
|
Placebo
n=9 Participants
inert capsule taken orally
|
|---|---|---|
|
Unpleasantness of Breathlessness
|
69.0 units on a scale
Standard Deviation 24.9
|
71.1 units on a scale
Standard Deviation 24.6
|
PRIMARY outcome
Timeframe: Visit 2 (Approximately Day 3 where either Placebo or Aprepitant was administered).and Visit 3 (approximately Day 6 where either Placebo or Aprepitant was administered)Intensity of Breathlessness was recorded on a visual analog scale. The scale range is 0-10 where 0 = minimum and 10 = maximal intensity. At each visit, participants were asked to report unpleasantness at 1 minute intervals. The measures were collected up to 20 minutes per visit and combined for a final score. Total minimum score = 0, total maximum score 200. Data is collected during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7) during which either Placebo or Aprepitant was administered.
Outcome measures
| Measure |
Aprepitant
n=9 Participants
aprepitant 125 mg taken orally
|
Placebo
n=9 Participants
inert capsule taken orally
|
|---|---|---|
|
Intensity of Breathlessness
|
83.0 units on a scale
Standard Deviation 23.6
|
85.1 units on a scale
Standard Deviation 20.5
|
Adverse Events
Aprepitant
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place