Trial Outcomes & Findings for Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention (NCT NCT03686813)
NCT ID: NCT03686813
Last Updated: 2022-11-22
Results Overview
One or more of: hypoxemia, productive cough, pulmonary edema on chest radiograph, wheezing on chest auscultation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
During or immediately after exercise in cold water, approximately one hour and 40 minutes
Results posted on
2022-11-22
Participant Flow
Participant milestones
| Measure |
Placebo Oral Tablet, Then Sildenafil Citrate
Each participant first received placebo oral tablet one hour (once) before immersed exercise. After a washout period of at least 7 days, they then received Sildenafil citrate 50 mg orally one hour (once) before immersed exercise.
|
Sildenafil Citrate, Then Placebo Oral Tablet
Each participant first received Sildenafil citrate 50 mg orally one hour (once) before immersed exercise. After a washout period of at least 7 days, they then received placebo oral tablet one hour (once) before immersed exercise.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention
Baseline characteristics by cohort
| Measure |
Placebo Oral Tablet, Then Sildenafil Citrate
n=10 Participants
Each participant first received placebo oral tablet one hour (once) before immersed exercise. After a washout period of at least 7 days, they then received Sildenafil citrate 50 mg orally one hour (once) before immersed exercise.
|
Sildenafil Citrate, Then Placebo Oral Tablet
n=8 Participants
Each participant first received Sildenafil citrate 50 mg orally one hour (once) before immersed exercise. After a washout period of at least 7 days, they then received placebo oral tablet one hour (once) before immersed exercise.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
38.1 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During or immediately after exercise in cold water, approximately one hour and 40 minutesPopulation: Each participant was studied with active drug and placebo.
One or more of: hypoxemia, productive cough, pulmonary edema on chest radiograph, wheezing on chest auscultation.
Outcome measures
| Measure |
Placebo Oral Tablet
n=18 Participants
Each participant will be studied with active drug and placebo.
Placebo Oral Tablet: Placebo
|
Sildenafil Citrate
n=18 Participants
Sildenafil 50 mg orally one hour (once) before immersed exercise
Sildenafil Citrate: Oral sildenafil, 50 mg
|
|---|---|---|
|
Number of Participants With Pulmonary Edema
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: During or immediately after exercise in cold water, approximately one hour and 40 minutesPopulation: Each participant was studied with active drug and placebo.
Voluntary premature cessation of exercise due to shortness of breath.
Outcome measures
| Measure |
Placebo Oral Tablet
n=18 Participants
Each participant will be studied with active drug and placebo.
Placebo Oral Tablet: Placebo
|
Sildenafil Citrate
n=18 Participants
Sildenafil 50 mg orally one hour (once) before immersed exercise
Sildenafil Citrate: Oral sildenafil, 50 mg
|
|---|---|---|
|
Number of Participants With Dyspnea Leading to Voluntary Premature Cessation of Exercise
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Immediately after exercise in cold water, approximately one hour and 40 minutesPopulation: Each participant was studied with active drug and placebo.
Post-exercise 10% decrease in forced vital capacity (FVC) or forced expiratory volume in one second (FEV1).
Outcome measures
| Measure |
Placebo Oral Tablet
n=18 Participants
Each participant will be studied with active drug and placebo.
Placebo Oral Tablet: Placebo
|
Sildenafil Citrate
n=18 Participants
Sildenafil 50 mg orally one hour (once) before immersed exercise
Sildenafil Citrate: Oral sildenafil, 50 mg
|
|---|---|---|
|
Number of Participants With Post-exercise 10% Decrease in Forced Vital Capacity (FVC) or Forced Expiratory Volume in One Second (FEV1) as Measured by Spirometry
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Immediately after exercise in cold water, approximately one hour and 40 minutesPopulation: Each participant was studied with active drug and placebo.
A "comet tail" artefact is a short path reverberation artefact that weakens with each reverberation, resulting in a vertical echogenic artefact that rapidly fades as it continues in to the ultrasound image.
Outcome measures
| Measure |
Placebo Oral Tablet
n=18 Participants
Each participant will be studied with active drug and placebo.
Placebo Oral Tablet: Placebo
|
Sildenafil Citrate
n=18 Participants
Sildenafil 50 mg orally one hour (once) before immersed exercise
Sildenafil Citrate: Oral sildenafil, 50 mg
|
|---|---|---|
|
Number of Participants With "Comet Tails" Seen on Ultrasound of the Lungs
|
17 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Immediately after exercise in cold water, approximately one hour and 40 minutesPopulation: Each participant was studied with active drug and placebo.
Outcome measures
| Measure |
Placebo Oral Tablet
n=18 Participants
Each participant will be studied with active drug and placebo.
Placebo Oral Tablet: Placebo
|
Sildenafil Citrate
Sildenafil 50 mg orally one hour (once) before immersed exercise
Sildenafil Citrate: Oral sildenafil, 50 mg
|
|---|---|---|
|
Number of Participants Who Found the Exercise Easiest When Given Sildenafil Citrate Versus When Given Placebo
Placebo Oral Tablet
|
5 Participants
|
—
|
|
Number of Participants Who Found the Exercise Easiest When Given Sildenafil Citrate Versus When Given Placebo
Sildenafil Citrate
|
9 Participants
|
—
|
|
Number of Participants Who Found the Exercise Easiest When Given Sildenafil Citrate Versus When Given Placebo
No Difference
|
4 Participants
|
—
|
Adverse Events
Placebo Oral Tablet, Then Sildenafil Citrate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sildenafil Citrate, Then Placebo Oral Tablet
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