Evidence map›Paper›PMID 37261531›Full record

Trial reportLung2023

Efficacy and Safety of Eliapixant in Refractory Chronic Cough: The Randomized, Placebo-Controlled Phase 2b PAGANINI Study.

Peter V Dicpinigaitis, Alyn H Morice, Jaclyn A Smith, Mandel R Sher, Michael Vaezi, Laurent Guilleminault, Akio Niimi, Kerstin Gude, Ulrike Krahn, Riitta Saarinen and 4 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Lung, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04562155 (Randomized, Double-blind, Parallel Group, Phase 2b Dose-finding, Efficacy and Safety Study of 12-week Twice Daily Oral Administration of BAY 1817080 Compared to Placebo in the Treatment of Refractory and/or Unexplained Chronic Cough), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
9.6field-weighted citation impact, top 2% 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.

NCT04562155 phase2completednot on this map

Randomized, Double-blind, Parallel Group, Phase 2b Dose-finding, Efficacy and Safety Study of 12-week Twice Daily Oral Administration of BAY 1817080 Compared to Placebo in the Treatment of Refractory and/or Unexplained Chronic Cough (RUCC)

TypeinterventionalSponsorBayerRan2020 to 2021Enrolled310ConditionsRefractory and/or Unexplained Chronic CoughArmsBAY1817080, Placebo
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

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  5. Camlipixant in Refractory Chronic Cough: A Phase 2b, Randomized, Placebo-controlled Trial (SOOTHE).American journal of respiratory and critical care medicine · 2025
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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

14 authors at 10 institutions in 6 countries.

Peter V DicpinigaitisDepartment of Medicine, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, USA.
Alyn H MoriceCentre for Clinical Sciences, Hull York Medical School, University of Hull, Hull, UK.
Jaclyn A SmithDivision of Immunology, Immunity to Infection and Respiratory Medicine, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.
Mandel R SherCenter for Cough, Largo, FL, USA.
Michael VaeziDivision of Gastroenterology, Hepatology and Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.
Laurent GuilleminaultPôle des Voies Respiratoires, CHU de Toulouse, Toulouse, France.
Akio NiimiDepartment of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University, Nagoya, Japan.
Kerstin GudePharmacovigilance, Bayer AG, Berlin, Germany.
Ulrike KrahnResearch and Development, Bayer AG, Wuppertal, Germany.
Riitta SaarinenMedical and Scientific Affairs, Bayer AG, Espoo, Finland.
Philippe Vieira PiresResearch and Development, Bayer AG, Wuppertal, Germany.
Melanie WosnitzaResearch and Development, Bayer AG, Wuppertal, Germany.
Lorcan McGarveyWellcome Wolfson Institute of Experimental Medicine, Queen's University Belfast, Belfast, UK. l.mcgarvey@qub.ac.uk.ORCID 0000-0002-2860-0302
PAGANINI Investigators
Bayer (Germany) · DEAlbert Einstein College of Medicine · USBayer (Finland) · FICentre Hospitalier Universitaire de Toulouse · FRFlorida Center for Gastroenterology · USManchester University NHS Foundation Trust · GBNagoya City University · JPQueen's University Belfast · GBUniversity of Hull · GBVanderbilt University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe PAGANINI study evaluated the efficacy and safety of the selective P2X3 antagonist eliapixant in patients with refractory chronic cough (RCC).

methodsPAGANINI was a randomized, double-blind, parallel-group, placebo-controlled, multicenter, dose-finding, phase 2b study. Adults with RCC lasting ≥ 12 months and cough severity ≥ 40 mm on a visual analog scale at screening were enrolled. Participants were randomized 1:1:1:1 to twice-daily 25 mg, 75 mg, or 150 mg oral eliapixant or placebo for 12 weeks. The primary endpoint was change from baseline in 24-h cough count after 12 weeks of intervention.

resultsOverall, 310 participants were randomized to twice-daily eliapixant 25 mg (n = 75), 75 mg (n = 78), 150 mg (n = 80), or placebo (n = 77). A statistically significant dose-response signal with eliapixant was detected for the primary endpoint (all dose-response models, adjusted p < 0.1; one-sided). Adverse events (AEs) were reported in 39 (51%) participants with placebo and 43-51 (57-65%) participants receiving eliapixant. The most common AE was dysgeusia, occurring in 1% (n = 1) of the placebo group and 1-16% (n = 1-13) of the eliapixant groups in a dose-related manner. One case of a moderate drug-induced liver injury occurred in a participant receiving 150 mg twice-daily eliapixant.

conclusionEliapixant demonstrated efficacy and a favorable taste tolerability profile in RCC. However, a drug-induced liver injury contributed to intensified liver monitoring in clinical trials with eliapixant and discontinuation of the entire development program in all indications by Bayer AG.

trial registrationClinicalTrials.gov identifier NCT04562155; registered September 18, 2020.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsAdultCoughDouble-Blind MethodHumansTreatment OutcomeChronic coughEliapixantP2X3 receptor antagonistPhase 2b clinical trial

Identifiers

PMID37261531
PMCPMC10234230
OpenAlexW4378953171

What OpenQuestion holds

Textmetadata
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.