Trial Outcomes & Findings for The Role of Substance P on Perception of Breathlessness During Resistive Load Breathing (NCT NCT01580423)
NCT ID: NCT01580423
Last Updated: 2013-07-19
Results Overview
Time-weighted averages of intensity of breathlessness. 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".
COMPLETED
NA
16 participants
At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)
2013-07-19
Participant Flow
Dates of recruitment: April to October 2012; Location: medical clinic
17 subjects recruited; 1 patient who signed the consent form did not meet inclusion/exclusion criteria, and no testing was performed.
Participant milestones
| Measure |
First Aprepitant, Then Inert Powder
Capsule of aprepitant 125 mg in first intervention period and capsule of inert powder in second intervention period.
|
First Inert Powder, Then Aprepitant
Capsule of inert powder in first intervention period and capsule of aprepitant 125 mg in second intervention period.
|
|---|---|---|
|
First Intervention
STARTED
|
8
|
8
|
|
First Intervention
COMPLETED
|
8
|
8
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
8
|
8
|
|
Second Intervention
COMPLETED
|
8
|
8
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of Substance P on Perception of Breathlessness During Resistive Load Breathing
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=16 Participants
Includes groups randomized to receive aprepitant first and inert powder first.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age Continuous
|
70.2 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 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)Time-weighted averages of intensity of breathlessness. 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
| Measure |
Aprepitant
n=16 Participants
Capsule containing 125 mg of aprepitant
|
Inert Powder
n=16 Participants
Capsule containing inert powder
|
|---|---|---|
|
Intensity of Breathlessness
|
80.8 units on a scale
Standard Deviation 13.5
|
77.9 units on a scale
Standard Deviation 14.5
|
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)Time-weighted averages of unpleasantness of breathlessness. Subject rating of unpleasantness of breathlessness was obtained at 1 minute intervals 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
| Measure |
Aprepitant
n=16 Participants
Capsule containing 125 mg of aprepitant
|
Inert Powder
n=16 Participants
Capsule containing inert powder
|
|---|---|---|
|
Unpleasantness of Breathlessness
|
76.2 units on a scale
Standard Deviation 16.7
|
72.2 units on a scale
Standard Deviation 20.3
|
SECONDARY outcome
Timeframe: Every 15 seconds during immersion of hand in cold water for up to 5 minutes at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)Time-weighted averages for intensity of pain. Subject rating of intensity of pain on a 100 mm Visual Analog Scale anchored at the bottom by "No Intensity" and at the top by "Greatest Intensity" was obtained during immersion of the subject's non-dominant hand in cold water.
Outcome measures
| Measure |
Aprepitant
n=16 Participants
Capsule containing 125 mg of aprepitant
|
Inert Powder
n=16 Participants
Capsule containing inert powder
|
|---|---|---|
|
Intensity of Pain
|
85.8 units on a scale
Standard Deviation 16.2
|
81.9 units on a scale
Standard Deviation 14.8
|
Adverse Events
Aprepitant
Inert Powder
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