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Prevention of High Altitude Pulmonary Edema

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00274430
First received: January 9, 2006
Last updated: November 30, 2006
Last verified: December 2003
  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 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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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
Edema
Hypertension, Pulmonary
Pulmonary Edema
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Tadalafil
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors

ClinicalTrials.gov processed this record on November 23, 2014