Prevention of High Altitude Pulmonary Edema

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.

Completed

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Key information

Conditions

High Altitude Pulmonary Edema Altitude Sickness Respiration Disorders Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

At least one previous episode of high altitude pulmonary edema

Exclusion criteria

pulmonary arterial hypertension
congenital heart disease
any chronic lung disease

Treatment and study plan

dexamethasone 8 mg bid

Drug

tadalafil 10mg bid

Drug

Primary outcomes

prevention of high altitude pulmonary edema

Secondary outcomes

incidence of acute mountain sickness

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start: 2003
Study completion: 2003
First posted: Jan 10, 2006
Registry last updated: Dec 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed