Prevention of High Altitude Pulmonary Edema
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.
Timeline
- Start
- 2003-07
- Primary completion
- —
- Completion
- 2003-09
Outcome
Met primary endpoint
paper High-altitude pulmonary edema developed in 7 of 9 participants receiving placebo and 1 of the remaining 8 participants receiving tadalafil PMID 17015867 ↗
paper but in none of the 10 participants receiving dexamethasone PMID 17015867 ↗
paper P = 0.007 for tadalafil vs. placebo; P < 0.001 for dexamethasone vs. placebo PMID 17015867 ↗
Publications
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 8 mg | — |
| Subject | Tadalafil | Small molecule | 10 mg | — |