Trial Outcomes & Findings for Hypoxic Pulmonary Vasoconstriction Pilot Study (NCT NCT03733470)
NCT ID: NCT03733470
Last Updated: 2019-10-01
Results Overview
Perfused blood volume will be measured by CT scan at two time points and compared at two points, pre and post the administration of sildenafil.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
Change of perfused blood volume from baseline at one hour after sildenafil administration.
Results posted on
2019-10-01
Participant Flow
Of 22 subjects, 3 were eliminated because of blood pressure or asthma medications leaving 8NS and 11SS subjects.
Participant milestones
| Measure |
Nonsusceptible Smokers (NS)
22 subjects recruited. Pre-sildenafil we imaged with no contrast at TLC and 20% vital capacity (VC). To assess perfused blood volume (PBV), we imaged at 20% VC . For the intervention, the subject were administered 20 mg of oral Sildenafil and PBV imaging was repeated one hour after sildenafil.
One group was labeled emphysema non-susceptible (NS) and another was emphysema susceptible (SS) based upon visual identification of emphysema in non-contrast CT scans. Of 22 subjects, 3 were eliminated because of blood pressure or asthma medications and two more were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects. The study was designed to determine if the NS subjects have a greater coefficient of variation (CV) within 30x30x40 regions (approximately the size of an acinus) and whether sildenafil would eliminate the difference between medians of the per block CV histograms for NS and SS.
|
Susceptible Smoker (SS)
22 subjects recruited. Pre-sildenafil we imaged with no contrast at TLC and 20% vital capacity (VC). To assess perfused blood volume (PBV), we imaged at 20% VC . For the intervention, the subject were administered 20 mg of oral Sildenafil and PBV imaging was repeated one hour after sildenafil.
One group was labeled emphysema non-susceptible (NS) and another was emphysema susceptible (SS) based upon visual identification of emphysema in non-contrast CT scans. Of 22 subjects, 3 were eliminated because of blood pressure or asthma medications and two more were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects. The study was designed to determine if the NS subjects have a greater coefficient of variation (CV) within 30x30x40 regions (approximately the size of an acinus) and whether sildenafil would eliminate the difference between medians of the per block CV histograms for NS and SS.
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|---|---|---|
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Overall Study
STARTED
|
8
|
11
|
|
Overall Study
COMPLETED
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Nonsusceptible Smokers (NS)
22 subjects recruited. Pre-sildenafil we imaged with no contrast at TLC and 20% vital capacity (VC). To assess perfused blood volume (PBV), we imaged at 20% VC . For the intervention, the subject were administered 20 mg of oral Sildenafil and PBV imaging was repeated one hour after sildenafil.
One group was labeled emphysema non-susceptible (NS) and another was emphysema susceptible (SS) based upon visual identification of emphysema in non-contrast CT scans. Of 22 subjects, 3 were eliminated because of blood pressure or asthma medications and two more were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects. The study was designed to determine if the NS subjects have a greater coefficient of variation (CV) within 30x30x40 regions (approximately the size of an acinus) and whether sildenafil would eliminate the difference between medians of the per block CV histograms for NS and SS.
|
Susceptible Smoker (SS)
22 subjects recruited. Pre-sildenafil we imaged with no contrast at TLC and 20% vital capacity (VC). To assess perfused blood volume (PBV), we imaged at 20% VC . For the intervention, the subject were administered 20 mg of oral Sildenafil and PBV imaging was repeated one hour after sildenafil.
One group was labeled emphysema non-susceptible (NS) and another was emphysema susceptible (SS) based upon visual identification of emphysema in non-contrast CT scans. Of 22 subjects, 3 were eliminated because of blood pressure or asthma medications and two more were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects. The study was designed to determine if the NS subjects have a greater coefficient of variation (CV) within 30x30x40 regions (approximately the size of an acinus) and whether sildenafil would eliminate the difference between medians of the per block CV histograms for NS and SS.
|
|---|---|---|
|
Overall Study
PI Decision
|
1
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1
|
Baseline Characteristics
2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects
Baseline characteristics by cohort
| Measure |
Nonsusceptible Smokers (NS)
n=7 Participants
8 emphysema nonsusceptible smokers recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.
|
Susceptible Smokers (SS)
n=10 Participants
11 emphysema susceptible smokers recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects
|
0 Participants
n=7 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects
|
0 Participants
n=5 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects
|
10 Participants
n=7 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects
|
17 Participants
n=5 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects
|
0 Participants
n=7 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects
|
0 Participants
n=5 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects.
|
9 Participants
n=7 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects.
|
15 Participants
n=5 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects.
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects.
|
1 Participants
n=7 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects.
|
2 Participants
n=5 Participants • 2 subjects were eliminated after scanning because of mis-matched pre and post sildenafil lung volumes, leaving 7NS and 10SS subjects.
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change of perfused blood volume from baseline at one hour after sildenafil administration.Perfused blood volume will be measured by CT scan at two time points and compared at two points, pre and post the administration of sildenafil.
Outcome measures
| Measure |
Nonsusceptible Smokers (NS)
n=7 Participants
7 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, one dose of 20 mg Sildenafil was administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.
One dose of 20 mg Sildenafil will be given one hour before CT imaging.
|
Susceptible Smoker (SS)
n=10 Participants
10 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, one dose of 20 mg Sildenafil was administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.
One dose of 20 mg Sildenafil will be given one hour before CT imaging.
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|---|---|---|
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Perfused Blood Volume Assessed for a Change in Lung Inflammation Pre and Post Dose Sildenafil Administration
|
0.37 coefficient of variation
Standard Deviation 0.03
|
0.42 coefficient of variation
Standard Deviation 0.09
|
Adverse Events
Nonsusceptible Smokers (NS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Susceptible Smokers (SS)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place