Evidence map›Paper›PMID 28857147›Full record

Trial reportClinical pharmacology and therapeutics2018

Safety and Ergogenic Properties of Combined Aminophylline and Ambrisentan in Hypoxia.

Thies Schroeder, Claude A Piantadosi, Michael J Natoli, Julie Autmizguine, Michael Cohen-Wolkowieczs, Karyn L Hamilton, Christopher Bell, Jelena Klawitter, Uwe Christians, David C Irwin and 1 more

Open access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 3 countries.

Thies SchroederDepartment of Biochemistry, University of Mainz, Germany.
Claude A PiantadosiHyperbaric Center, Duke University Medical Center, Durham, North Carolina, USA.
Michael J NatoliHyperbaric Center, Duke University Medical Center, Durham, North Carolina, USA.
Julie AutmizguineDepartment of Pharmacology, University of Montreal, Montreal, Quebec, Canada.
Michael Cohen-WolkowieczsDuke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, North Carolina, USA.
Karyn L HamiltonDepartment of Health and Exercise Science, Colorado State University, Fort Collins, Colorado, USA.ORCID 0000-0002-6320-8824
Christopher BellDepartment of Health and Exercise Science, Colorado State University, Fort Collins, Colorado, USA.
Jelena KlawitteriC42 Integrated Solutions in Clinical Research and Development, University of Colorado, Bioscience East, Aurora, Colorado, USA.ORCID 0000-0003-1893-6141
Uwe ChristiansiC42 Integrated Solutions in Clinical Research and Development, University of Colorado, Bioscience East, Aurora, Colorado, USA.
David C IrwinDepartment of Medicine, University of Colorado Denver Anschutz Campus, Aurora, Colorado, USA.
Robert J NoveckHyperbaric Center, Duke University Medical Center, Durham, North Carolina, USA.
Duke University · USClinical Solutions · USColorado State University · USClinical Research Institute · USUniversité de Montréal · CAUniversity of Applied Sciences Mainz · DEUniversity of Colorado Anschutz Medical Campus · US

Funding

Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
PILOT STUDY--SUBSTRATE METABOLISM IN EXTREMELY LOW BIRTH WEIGHT INFANTSP30DK048520 · NIDDK · UNIVERSITY OF COLORADO DENVER · PI JANINE A HIGGINS · 1995 to 2026
$32.6M
NCATS NIH HHS UL1 TR001117
6 · The paper itself

Abstract

We hypothesized that concomitant pharmacological inhibition of the endothelin and adenosine pathway is safe and improves exercise performance in hypoxic humans, via a mechanism that does not involve augmentation of blood oxygenation. To test this hypothesis, we established safety and drug interactions for aminophylline (500 mg) plus ambrisentan (5 mg) in normoxic volunteers. Subsequently, a placebo-controlled study was employed to test the combination in healthy resting and exercising volunteers at simulated altitude (4,267 m). No serious adverse events occurred. Drug interaction was minimal or absent. Aminophylline alleviated hypoxia-induced headaches. Aminophylline, ambrisentan, and their combination all significantly (P < 0.05 vs. placebo) improved submaximal hypoxic exercise performance (19.5, 20.6, and 19.1% >placebo). Single-dose ambrisentan increased blood oxygenation in resting, hypoxic subjects. We conclude that combined aminophylline and ambrisentan offer promise to safely increase exercise capacity in hypoxemic humans without relying on increasing blood oxygen availability.

Indexed as

AdenosineAdolescentAdultAltitudeAminophyllineDouble-Blind MethodDrug Therapy, CombinationEndothelinsExerciseFemaleHumansHypoxiaMaleMiddle AgedPhenylpropionatesPyridazinesAdenosineambrisentanAminophyllineEndothelinsPhenylpropionatesPyridazines

Identifiers

PMID28857147
PMCPMC5947522
OpenAlexW2751834855

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.