Prevention of High Altitude Pulmonary Edema

A Randomized Controlled Trial of the Effects of Tadalafil and Dexamethasone Versus Placebo on Pulmonary Edema Formation and Cerebral Blood Flow Autoregulation in High Altitude Newcomers With a Previous History of High Altitude Pulmonary Edema

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00274430

Enrollment

Registered

2006-01-10

Start date

2003-07-31

Completion date

2003-09-30

Last updated

2006-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Altitude Pulmonary Edema

Brief summary

A double-blind placebo controlled study * To compare the effect of tadalafil and dexamethasone versus placebo on Ppa and pulmonary edema formation in subjects susceptible to HAPE. * To investigate the effect of dexamethasone on alveolar fluid clearance, as assessed by measurement of the nasal potential difference, and prevention of HAPE. * To investigate the effect of the tadalafil and dexamethasone versus placebo on the dynamic CBF autoregulation properties and on the development of AMS in HAPE susceptible subjects.

Interventions

DRUGdexamethasone 8 mg bid

DRUGtadalafil 10mg bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* At least one previous episode of high altitude pulmonary edema

Exclusion criteria

* pulmonary arterial hypertension * congenital heart disease * any chronic lung disease

Design outcomes

Primary

Measure	Time frame
prevention of high altitude pulmonary edema	—

Secondary

Measure	Time frame
incidence of acute mountain sickness	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026