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Prevention of High Altitude Pulmonary Edema

Primary Purpose

High Altitude Pulmonary Edema

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
dexamethasone 8 mg bid
tadalafil 10mg bid
Sponsored by
University of Zurich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for High Altitude Pulmonary Edema

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: At least one previous episode of high altitude pulmonary edema Exclusion Criteria: pulmonary arterial hypertension congenital heart disease any chronic lung disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    prevention of high altitude pulmonary edema

    Secondary Outcome Measures

    incidence of acute mountain sickness

    Full Information

    First Posted
    January 9, 2006
    Last Updated
    November 30, 2006
    Sponsor
    University of Zurich
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00274430
    Brief Title
    Prevention of High Altitude Pulmonary Edema
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2003
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2003 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Zurich

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High Altitude Pulmonary Edema

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    30 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    dexamethasone 8 mg bid
    Intervention Type
    Drug
    Intervention Name(s)
    tadalafil 10mg bid
    Primary Outcome Measure Information:
    Title
    prevention of high altitude pulmonary edema
    Secondary Outcome Measure Information:
    Title
    incidence of acute mountain sickness

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marco Maggiorini, MD
    Organizational Affiliation
    University of Zurich
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17015867
    Citation
    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. doi: 10.7326/0003-4819-145-7-200610030-00007.
    Results Reference
    result
    PubMed Identifier
    22829927
    Citation
    Clarenbach CF, Senn O, Christ AL, Fischler M, Maggiorini M, Bloch KE. Lung function and breathing pattern in subjects developing high altitude pulmonary edema. PLoS One. 2012;7(7):e41188. doi: 10.1371/journal.pone.0041188. Epub 2012 Jul 19.
    Results Reference
    derived

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    Prevention of High Altitude Pulmonary Edema

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