Prevention of High Altitude Pulmonary Edema - Full Text View

Sponsored by:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00274430

Purpose

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.

Condition	Intervention	Phase
High Altitude Pulmonary Edema	Drug: dexamethasone 8 mg bid Drug: tadalafil 10mg bid	Phase I Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Edema

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Tadalafil Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:

prevention of high altitude pulmonary edema

Secondary Outcome Measures:

incidence of acute mountain sickness

Estimated Enrollment:	30
Study Start Date:	July 2003
Estimated Study Completion Date:	September 2003

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

At least one previous episode of high altitude pulmonary edema

Exclusion Criteria:

pulmonary arterial hypertension
congenital heart disease
any chronic lung disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274430

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator:

Marco Maggiorini, MD

University of Zurich

More Information

Publications:

Maggiorini M, Brunner-La Rocca HP, Peth S, Fischler M, Bohm T, Bernheim A, Kiencke S, Bloch KE, Dehnert C, Naeije R, Lehmann T, Bartsch P, Mairbaurl H. Both tadalafil and dexamethasone may reduce the incidence of high-altitude pulmonary edema: a randomized trial. Ann Intern Med. 2006 Oct 3;145(7):497-506. Summary for patients in: Ann Intern Med. 2006 Oct 3;145(7):I28.

Study ID Numbers:	margherita03
Study First Received:	January 9, 2006
Last Updated:	November 30, 2006
ClinicalTrials.gov Identifier:	NCT00274430 History of Changes
Health Authority:	Switzerland: Swissmedic

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents, Hormonal
Hormone Antagonists
Respiration Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Antiemetics
Hormones
Glucocorticoids
Altitude Sickness

Signs and Symptoms
Phosphodiesterase Inhibitors
Pulmonary Edema
Respiratory Tract Diseases
Lung Diseases
Pulmonary Edema of Mountaineers
Tadalafil
Peripheral Nervous System Agents
Acute Mountain Sickness
Dexamethasone acetate

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Edema
Hormones
Signs and Symptoms
Altitude Sickness
Respiratory Tract Diseases
Therapeutic Uses
Dexamethasone acetate

Antineoplastic Agents, Hormonal
Respiration Disorders
Gastrointestinal Agents
Enzyme Inhibitors
Glucocorticoids
Pharmacologic Actions
Pulmonary Edema
Phosphodiesterase Inhibitors
Autonomic Agents
Lung Diseases
Tadalafil
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 02, 2009