Evidence map›Paper›PMID 28378369›Full record

Trial reportAllergy2017

A randomized controlled phase II clinical trial comparing ONO-4053, a novel DP1 antagonist, with a leukotriene receptor antagonist pranlukast in patients with seasonal allergic rhinitis.

K Okubo, K Hashiguchi, T Takeda, K Baba, H Kitagoh, H Miho, H Tomomatsu, S Yamaguchi, M Odani, H Yamamotoya

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Allergy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.7field-weighted citation impact, top 16% 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

10 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Focused allergic rhinitis practice parameter for Canada.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2024
    Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Innate Lymphoid Cells in Mucosal Immunity.Frontiers in immunology · 2019
    Review
  10. Review
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

10 authors at 8 institutions in 1 country.

K OkuboDepartment of Otorhinolaryngology, Nippon Medical School, Tokyo, Japan.
K HashiguchiDepartment of Otorhinolaryngology, Futaba Clinic, Tokyo, Japan.
T TakedaDepartment of Otorhinolaryngology, Takeda Clinic, Saitama, Japan.
K BabaDepartment of Otorhinolaryngology, Takasaka Clinic, Saitama, Japan.
H KitagohDepartment of Otorhinolaryngology, Kitagoh Clinic, Kanagawa, Japan.
H MihoDepartment of Otorhinolaryngology, Miho Clinic, Kanagawa, Japan.
H TomomatsuDepartment of Otorhinolaryngology, Tomomatsu Clinic, Tokyo, Japan.
S YamaguchiDiscovery Research Laboratories III, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
M OdaniData Science, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
H YamamotoyaTranslational Science, Ono Pharmaceutical Co., Ltd., Osaka, Japan.ORCID http://orcid.org/0000-0003-1960-9257
Ono Pharmaceutical (Japan) · JPDisco (japan) · JPFutaba clinic · JPMiwa Internal Medicine Clinic · JPNippon Medical School · JPTakasago (Japan) · JPTakeda (Japan) · JPToagosei (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProstaglandin D

objectiveThis study aimed to evaluate the efficacy and safety of a novel PGD

methodsThis study was a multicenter, randomized, double-blind, parallel-group study of patients with SAR. Following a one-week period of placebo run-in, patients who met the study criteria were randomized to either the ONO-4053, leukotriene receptor antagonist pranlukast, or placebo group for a two-week treatment period. A total of 200 patients were planned to be randomly assigned to receive ONO-4053, pranlukast, or placebo in a 2:2:1 ratio. Nasal and eye symptoms were evaluated.

resultsBoth ONO-4053 and pranlukast had higher efficacy than placebo on all nasal and eye symptoms. ONO-4053 outperformed pranlukast in a total of three nasal symptom scores (T3NSS) as well as in individual scores for sneezing, rhinorrhea, and nasal itching. For T3NSS, the Bayesian posterior probabilities that pranlukast was better than placebo and ONO-4053 was better than pranlukast were 70.0% and 81.6%, respectively, suggesting that ONO-4053 has a higher efficacy compared with pranlukast. There was no safety-related issue in this study.

conclusionsWe demonstrated that the efficacy of ONO-4053 was greater than that of pranlukast with a similar safety profile. This study indicates the potential of ONO-4053 for use as a treatment for SAR (JapicCTI-142706).

Indexed as

AdultCell DegranulationChromonesDrug Therapy, CombinationFemaleHumansLeukotriene AntagonistsMaleMast CellsMiddle AgedReceptors, ProstaglandinRhinitis, Allergic, SeasonalSeverity of Illness IndexSymptom AssessmentTreatment OutcomeYoung AdultChromonesLeukotriene Antagonistspranlukastprostanoid D receptor 1, humanReceptors, Prostaglandinallergic rhinitisBayesian posterior probabilityleukotriene receptor antagonistmast cell degranulationprostaglandin D2 receptor 1 antagonist

Identifiers

PMID28378369
PMCPMC5638107
OpenAlexW2604619231

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.