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NCT03686813 · ClinicalTrials.gov registry record · Phase 2

Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention

A Phase 2 study of Edema, Pulmonary and Immersion, sponsored by Duke University.

Completed
Registry status
Phase 2
Development phase
18
Enrollment target
1
Study location

NCT03686813: Completed Phase 2 study of Edema, Pulmonary and Immersion, sponsored by Duke University.

NCT03686813 is a Phase 2 study of Edema, Pulmonary and Immersion that has completed, run by Duke University. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03686813, a Phase 2 study of Edema, Pulmonary and Immersion, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 2
Development phase
18 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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

Interventions

  • DRUG Placebo Oral Tablet
  • DRUG Sildenafil Citrate

Study Locations (1)

North Carolina

  • Duke University Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2019-07-15
Est. Completion 2021-10-29
Phase Phase 2
Duke University

1,725 total trials

What the finished NCT03686813 record still lists

NCT03686813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

The record links to 3 conditions, with Edema, Pulmonary appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Tablet is the first listed.

NCT03686813 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT03686813 about?

NCT03686813 is a clinical study titled "Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention". 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.

What is the current status of trial NCT03686813?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2019-07-15. Estimated completion is 2021-10-29.

What conditions does trial NCT03686813 study?

This clinical trial studies the following conditions: Edema, Pulmonary, Immersion, Diving.

What interventions are being tested in trial NCT03686813?

The interventions under investigation include: Placebo Oral Tablet (DRUG), Sildenafil Citrate (DRUG).

Who is sponsoring clinical trial NCT03686813?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03686813 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03686813's enrollment target sits among peer trials

18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03686813, the US trial registry maintained by the National Library of Medicine. NCT03686813 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.