Evidence map›Paper›PMID 26391974›Full record

Trial reportAntiviral research2015

Phase 1 clinical trials of DAS181, an inhaled sialidase, in healthy adults.

Jonathan M Zenilman, Edward J Fuchs, Craig W Hendrix, Christine Radebaugh, Robert Jurao, Seema U Nayak, Robert G Hamilton, J McLeod Griffiss

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

Trial report in Antiviral research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
4.1field-weighted citation impact, top 6% 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

40 citing papers in PubMed, 62 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Acute and Subacute Toxicity of Sialidase FromVeterinary medicine international · 2025
    Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Antiviral Approaches against Influenza Virus.Clinical microbiology reviews · 2023
    Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. 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

8 authors at 3 institutions in 1 country.

Jonathan M ZenilmanDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States. Electronic address: jzenilma@jhmi.edu.
Edward J FuchsClinical Pharmacology, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States.
Craig W HendrixClinical Pharmacology, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States.
Christine RadebaughClinical Pharmacology, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States.
Robert JuraoDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States.
Seema U NayakDivision of Infectious Diseases, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States.
Robert G HamiltonDivision of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States.
J McLeod GriffissClinical RM, Inc., Hinckley, OH, United States.
Johns Hopkins University · USClinical Research Management · USJohns Hopkins Medicine · US

Funding

NIAID NIH HHS HHSN272200800026CPHS HHS HHSN272200800026
6 · The paper itself

Abstract

DAS181, (study drug, Fludase®) was developed for treatment of influenza and parainfluenza infections. Delivered by inhalation, DAS181 cleaves sialic acid receptors from respiratory epithelial cells. Treatment of influenza for three days with DAS181 reduced viral shedding. To increase deposition in the upper airways and decrease systemic absorption, the particle size was increased to 10μm. We conducted two Phase I trials with three cohorts, randomized 2:1, active drug to placebo. The initial cohort got a single 20mg dose of DAS181, or placebo; the second, 20mg DAS181 or placebo for 10days, and the third got 20mg of DAS181 or placebo for 3days. Formulations differed slightly in their excipients. Subjects in the 1- and 3-day cohorts completed dosing without serious adverse events. Two subjects in the 10-day cohort stopped at Day 9 after developing respiratory and systemic symptoms, and a third experienced a decrease in FEV1 (Forced Expiratory Volume in 1s) after the 9th dose and a further decline after the 10th dose. Plasma DAS181, in the 10-day cohort, peaked and began falling before the last dose. Antibodies, predominately IgG with neutralizing activity, were detected in 15/18 subjects by Day 30. The highest IgG concentrations were in the 10-day cohort. The respiratory adverse events occurring after seven days and rapid drug clearance during continued dosing are consistent with the induction of DAS181 antibodies. This could preclude use of this medication for longer than seven days or for repeated courses. (These studies have been registered at ClinicalTrials.gov under registration Nos. NCT 00527865 and NCT 01651494.).

Indexed as

Administration, InhalationAdultAntibodiesAntiviral AgentsDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleHealthy VolunteersHumansImmunoglobulin GMaleNeuraminidasePlacebosRecombinant Fusion ProteinsAntibodiesAntiviral AgentsImmunoglobulin GNeuraminidaseoplunofuspPlacebosRecombinant Fusion ProteinsDAS-181InfluenzaParainfluenzaSialidase

Identifiers

PMID26391974
PMCPMC4639451
OpenAlexW2169899780

What OpenQuestion holds

Textmetadata
LicenceTDM
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.