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Prevention of High Altitude Pulmonary Edema

This study has been completed.
Information provided by:
University of Zurich Identifier:
First received: January 9, 2006
Last updated: November 30, 2006
Last verified: December 2003

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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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:

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

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00274430

Sponsors and Collaborators
University of Zurich
Principal Investigator: Marco Maggiorini, MD University of Zurich
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00274430     History of Changes
Other Study ID Numbers: margherita03 
Study First Received: January 9, 2006
Last Updated: November 30, 2006
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Altitude Sickness
Pulmonary Edema
Hypertension, Pulmonary
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors processed this record on October 21, 2016