Evidence map›Paper›PMID 33997741›Full record

ArticleEClinicalMedicine2021

Efficacy and safety of fevipiprant in patients with uncontrolled asthma: Two replicate, phase 3, randomised, double-blind, placebo-controlled trials (ZEAL-1 and ZEAL-2).

Mario Castro, Edward Kerwin, David Miller, Andrew Pedinoff, Lawrence Sher, Pamela Cardenas, Barbara Knorr, David Lawrence, Diego Ossa, Wei Wang and 1 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
3.7field-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.

NCT03215758 phase3completednot on this map

A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

TypeinterventionalSponsorNovartis PharmaceuticalsRan2017 to 2019Enrolled675ConditionsAsthmaArmsQAW039, Placebo
NCT03226392 phase3completednot on this map

A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

TypeinterventionalSponsorNovartis PharmaceuticalsRan2017 to 2019Enrolled704ConditionsAsthmaArmsQAW039, Placebo
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 33 citations in OpenAlex.

  1. Efficacy of an oral CRTH2 antagonist (AZD1981) in the treatment of chronic rhinosinusitis with nasal polyps in adults: A randomized controlled clinical trial.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2022
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  11. T-cell responses in asthma exacerbations.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2022
    Review
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  16. Prostaglandin DRespiratory research · 2021
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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.

Mario CastroDivision of Pulmonary, Critical Care Medicine, University of Kansas School of Medicine, Kansas City, KS, USA.
Edward KerwinClinical Research Institute of Southern Oregon, Medford, OR, USA.
David MillerNortheast Medical Research Associates, Inc., North Dartmouth, MA, USA.
Andrew PedinoffPrinceton Allergy & Asthma Associates, Skillman, NJ, USA.
Lawrence SherPeninsula Research Associates, Rolling Hills Estates, CA, USA.
Pamela CardenasNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Barbara KnorrNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
David LawrenceNovartis Pharma AG, Basel, Switzerland.
Diego OssaNovartis Pharma AG, Basel, Switzerland.
Wei WangNovartis Institutes for Biomedical Research Co., Ltd, Shanghai, China.
Jorge F MasperoAllergy and Respiratory Research Unit, Fundación CIDEA, Buenos Aires, Argentina.
Novartis (Switzerland) · CHNovartis (United States) · USClinical Research Institute · USMedical Research Associates · USNovartis (China) · CNPeninsula Research · USUniversity of Kansas · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThese studies assessed the efficacy and safety of fevipiprant, an oral antagonist of the prostaglandin D

methodsZEAL-1 (NCT03215758) and ZEAL-2 (NCT03226392) are two replicate, phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel-group studies in which fevipiprant 150 mg once daily (o.d.) or placebo was added to SoC asthma therapy in patients aged ≥12 years with uncontrolled asthma. Primary endpoint: change from baseline in pre-dose forced expiratory volume in 1 s (FEV

findings662 patients in ZEAL-1 and 685 patients in ZEAL-2 completed the treatment period. In ZEAL-1, the least squares (LS) mean change from baseline in pre-dose FEV

interpretationThe ZEAL studies did not demonstrate significant improvement in lung function or other clinical outcomes. These results suggest that DP

Identifiers

PMID33997741
PMCPMC8099656
OpenAlexW3159402038

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.