NCT03686813

Brief Summary

This trial is testing the effectiveness of a single oral dose of sildenafil (50 mg) taken 1 hour before a provocative event on the subsequent development of swimming-induced pulmonary edema.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 22, 2022

Completed
Last Updated

November 22, 2022

Status Verified

October 1, 2022

Enrollment Period

2.3 years

First QC Date

September 24, 2018

Results QC Date

October 28, 2022

Last Update Submit

October 28, 2022

Conditions

Edema, PulmonaryImmersionDiving

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Pulmonary Edema

    One or more of: hypoxemia, productive cough, pulmonary edema on chest radiograph, wheezing on chest auscultation.

    During or immediately after exercise in cold water, approximately one hour and 40 minutes

Secondary Outcomes (4)

  • Number of Participants With Dyspnea Leading to Voluntary Premature Cessation of Exercise

    During or immediately after exercise in cold water, approximately one hour and 40 minutes

  • 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

    Immediately after exercise in cold water, approximately one hour and 40 minutes

  • Number of Participants With "Comet Tails" Seen on Ultrasound of the Lungs

    Immediately after exercise in cold water, approximately one hour and 40 minutes

  • Number of Participants Who Found the Exercise Easiest When Given Sildenafil Citrate Versus When Given Placebo

    Immediately after exercise in cold water, approximately one hour and 40 minutes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Each participant will be studied with active drug and placebo.

Drug: Placebo Oral Tablet

Sildenafil

ACTIVE COMPARATOR

Sildenafil 50 mg orally one hour (once) before immersed exercise

Drug: Sildenafil Citrate

Interventions

Sildenafil CitrateDRUG

Oral sildenafil, 50 mg

Also known as: Viagra, Revatio
Sildenafil
Placebo Oral TabletDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers between 18 and 45 years
  • History of swimming-induced pulmonary edema

You may not qualify if:

  • Pregnant women
  • Significant heart valve disease
  • Cardiomyopathy
  • Uncontrolled hypertension
  • Coronary artery disease
  • Obstructive lung disease
  • VO2max \<25 mL/kg as estimated by the University of Houston Non-Exercise Test
  • Previous adverse reaction to sildenafil
  • Use of antihypertensives or other drugs that are known to interact adversely with sildenafil (e.g. nitrates, alpha adrenergic blockers)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Pulmonary Edema

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Richard Moon, M.D.
Organization
Duke University
richard.moon@duke.edu
919-684-8762

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Placebo controlled
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Double blind, randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 27, 2018

Study Start

July 15, 2019

Primary Completion

October 29, 2021

Study Completion

October 29, 2021

Last Updated

November 22, 2022

Results First Posted

November 22, 2022

Record last verified: 2022-10

Locations

US(1)