Trial Outcomes & Findings for Effect of Ketoconazole on Breathlessness (NCT NCT01378520)
NCT ID: NCT01378520
Last Updated: 2018-06-01
Results Overview
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 Ketoconazole and 10 ratings during 10 minutes of RLB with inert powder, then ratings for unpleasantness through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 252 ratings for Ketoconazole and for inert powder. 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".
COMPLETED
PHASE4
20 participants
At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)
2018-06-01
Participant Flow
June 2011 - January 2012; medical center
23 subjects recruited; 1 excluded (did not meet inclusion/exclusion criteria); 2 withdrawn prior to randomization (1 could not tolerate breathing through the initial inspiratory resistance (15 cm H 2 O/L/s); 1 gave ratings of breathlessness of \< 50 mm on the VAS for the highest resistance (50 cm H2O/L/s))
Participant milestones
| Measure |
First Ketoconazole, Then Inert Powder
Ketoconzaole (600 mg taken orally) in first intervention period and inert powder (in capsule taken orally) in second intervention period.
|
First Inert Powder, Then Ketoconazole
Inert powder (in capsule taken orally) in first intervention period and Ketoconzaole (600 mg taken orally) in second intervention period.
|
|---|---|---|
|
First Intervention (Day 2-3)
STARTED
|
10
|
10
|
|
First Intervention (Day 2-3)
COMPLETED
|
10
|
10
|
|
First Intervention (Day 2-3)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (Day 4-6)
STARTED
|
10
|
10
|
|
Second Intervention (Day 4-6)
COMPLETED
|
10
|
10
|
|
Second Intervention (Day 4-6)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Ketoconazole on Breathlessness
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=20 Participants
Includes groups randomized to receive Ketoconazole first and inert powder first.
|
|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 6.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 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)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 Ketoconazole and 10 ratings during 10 minutes of RLB with inert powder, then ratings for unpleasantness through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 252 ratings for Ketoconazole and for inert powder. 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
| Measure |
Ketoconazole
n=20 Participants
Ketoconazole (600 mg given orally)
|
Inert Powder
n=20 Participants
Inert powder (in capsule taken orally)
|
|---|---|---|
|
Unpleasantness of Breathlessness
|
72.5 units on a scale
Standard Deviation 23.8
|
72.6 units on a scale
Standard Deviation 23.5
|
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)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 Ketoconazole and 10 ratings during 10 minutes of RLB with inert powder, 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 252 ratings for Ketoconazole and for inert powder. 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 |
Ketoconazole
n=20 Participants
Ketoconazole (600 mg given orally)
|
Inert Powder
n=20 Participants
Inert powder (in capsule taken orally)
|
|---|---|---|
|
Intensity of Breathlessness
|
77.6 units on a scale
Standard Deviation 22.3
|
78.2 units on a scale
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: At the end of resistance load breathing (4.5 hours after receiving the test article)Change between pre-treatment and post treatment serum levels of beta-endorphin immunoreactivity measured in pmol/L
Outcome measures
| Measure |
Ketoconazole
n=20 Participants
Ketoconazole (600 mg given orally)
|
Inert Powder
n=20 Participants
Inert powder (in capsule taken orally)
|
|---|---|---|
|
Change in Level of B-endorphin Immunoreactivity
|
153.9 pmol/L
Standard Deviation 18.0
|
93.9 pmol/L
Standard Deviation 7.9
|
Adverse Events
Ketoconazole
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