Prevention of High Altitude Pulmonary Edema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2003-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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High Altitude Pulmonary Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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dexamethasone 8 mg bid

Intervention Type DRUG

tadalafil 10mg bid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least one previous episode of high altitude pulmonary edema

Exclusion Criteria

* pulmonary arterial hypertension
* congenital heart disease
* any chronic lung disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Marco Maggiorini, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

References

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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.

Reference Type RESULT

PMID: 17015867 (View on PubMed)

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.

Reference Type DERIVED

PMID: 22829927 (View on PubMed)

Other Identifiers

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margherita03

Identifier Type: -

Identifier Source: org_study_id