Trial reportBMC infectious diseases2016
A phase 1 randomized, double-blind, placebo-controlled, crossover trial of DAS181 (Fludase®) in adult subjects with well-controlled asthma.
Trial report in BMC infectious diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01113034 (A Phase 1 Randomized Double-Blind Placebo-Crossover Safety Trial of DAS181), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
A Phase 1 Randomized Double-Blind Placebo-Crossover Safety Trial of DAS181 (Fludase®) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- Addition of anti-leukotriene agents to inhaled corticosteroids for adults and adolescents with persistent asthma.The Cochrane database of systematic reviews · 2017Pooled it
- Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2017Trial
- Principles and Therapeutics ofJournal of pharmacy & bioallied sciences · 2024Review
- A Comprehensive Investigation Regarding the Differentiation of the Procurable COVID-19 Vaccines.AAPS PharmSciTech · 2022Review
- Broad-Spectrum Activity of Small Molecules Acting against Influenza a Virus: Biological and Computational Studies.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Pulmonary Delivery of Biological Drugs.Pharmaceutics · 2020Review
- Novel Small Molecule Targeting the Hemagglutinin Stalk of Influenza Viruses.Journal of virology · 2019Article
- Destabilization of the human RED-SMU1 splicing complex as a basis for host-directed antiinfluenza strategy.Proceedings of the National Academy of Sciences of the United States of America · 2019Article
- Effective in Vivo Targeting of Influenza Virus through a Cell-Penetrating/Fusion Inhibitor Tandem Peptide Anchored to the Plasma Membrane.Bioconjugate chemistry · 2018Article
- Influenza antivirals currently in late-phase clinical trial.Influenza and other respiratory viruses · 2017Review
- Steroid resistance and concomitant respiratory infections: A challenging battle in pulmonary clinic.EXCLI journal · 2017Article
- Comparative review of respiratory diseases caused by coronaviruses and influenza A viruses during epidemic season.Microbes and infectionReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundInfluenza virus (IFV) infection is associated with increased morbidity and mortality in people with underlying lung disease. Treatment options for IFV are currently limited and antiviral resistance is a growing concern. DAS181, an inhaled antiviral with a unique mechanism of action, has shown promise in early clinical trials involving generally healthy human subjects. This study was undertaken to assess the safety and tolerability of DAS181 in individuals with underlying reactive airway disease.
methodsThis was a randomized, double-blind, placebo-controlled, crossover phase 1 study of DAS181-F02. Dry particle inhaler administration of 10 mg was done on 3 consecutive days in ten adult volunteers with well-controlled asthma. The primary outcome was the frequency of adverse events (AEs), grade 1 or higher that occurred during each study period.
resultsThere were 280 AEs among ten evaluable subjects (56.8 % active; 43.2 % placebo); 90.7 % were grade 1. No grade 3 or higher AEs occurred. A statistically significant association between exposure to DAS181 and experiencing any AE, a grade 1 AE, or a grade 2 AE was not detected. Overall, the majority of AEs were classified as possibly related (35.7 %), unlikely related (38.9 %), or unrelated (15.4 %) to study drug administration. However, there was a statistically significant association between exposure to DAS181 and experiencing a definitely or probably related AE. Respiratory effects, including dyspnea, dry cough, and chest discomfort related to respirations, accounted for all of the definitely related AEs and one of the most common probably related AEs.
conclusionsDAS181 was safe in this small study of otherwise healthy subjects with well-controlled asthma. However, the generalizability of these results is limited by the small sample size and generally mild nature of the subjects' asthma at baseline. The increased association of respiratory events classified as probably or definitely related to DAS181 administration suggests caution may need to be employed when administering DAS181 to individuals with less stable reactive airway disease. Further investigation in a controlled setting of the safety and efficacy of DAS181 in a larger population of asthmatic subjects with varying disease activity is warranted.
trial registrationClinicalTrials.gov NCT01113034 Trial Registration Date: April 27, 2010.
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Registered trials
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.