Evidence map›Paper›PMID 29765200›Full record

Trial reportDrug design, development and therapy2018

Efficacy and safety of the CRTh2 antagonist AZD1981 as add-on therapy to inhaled corticosteroids and long-acting β

Eric D Bateman, Christopher O'Brien, Paul Rugman, Sally Luke, Stefan Ivanov, Mohib Uddin

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01197794 (A Double-blind, Placebo-controlled, Randomised, Parallel-group, Phase II, Multi-centre Study to Assess the Efficacy, Safety and Tolerability of 4 Twice Daily Doses and 2 Once Daily Doses of AZD1981 Given as Tablets During 12 Weeks in Asthmatic Patients), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% 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.

NCT01197794 phase2completednot on this map

A Double-blind, Placebo-controlled, Randomised, Parallel-group, Phase II, Multi-centre Study to Assess the Efficacy, Safety and Tolerability of 4 Twice Daily Doses and 2 Once Daily Doses of AZD1981 Given as Tablets During 12 Weeks in Asthmatic Patients

TypeinterventionalSponsorAstraZenecaRan2010 to 2012Enrolled1,144ConditionsAsthma PatientsArmsAZD1981, Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. 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
    Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Type 2 immunity-driven diseases: Towards a multidisciplinary approach.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2021
    Review
  11. Review
  12. Immunologic Adverse Effects of Biologics for the Treatment of Atopy.Clinical reviews in allergy & immunology · 2020
    Review
  13. Asthma Phenotypes as a Guide for Current and Future Biologic Therapies.Clinical reviews in allergy & immunology · 2020
    Review
  14. Review
  15. 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

6 authors at 2 institutions in 3 countries.

Eric D BatemanDepartment of Medicine, University of Cape Town, Cape Town, 7700, South Africa.
Christopher O'BrienResearch and Development.
Paul RugmanResearch and Development.
Sally LukeResearch and Development.
Stefan IvanovResearch and Development.
Mohib UddinResearch and Development.
AstraZeneca (Japan) · JPUniversity of Cape Town · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the efficacy and safety of AZD1981, a potent, specific antagonist of the CRTh2 receptor, as add-on therapy to inhaled corticosteroids (ICS) and long-acting β PATIENTS AND

methodsIn this placebo-controlled, parallel-group Phase IIb study, patients with persistent atopic asthma on ICS and LABA were randomized to receive 12 weeks of treatment with placebo or AZD1981 (80 mg daily, 200 mg daily, and 10 mg, 40 mg, 100 mg, or 400 mg twice daily [BID]). The primary end point was the mean change from baseline in predose, prebronchodilator forced expiratory volume in 1 second (FEV

resultsIn total, 1,140 patients (99.7%) received study treatment. There were improvements in the primary end point across all treatment groups over 12 weeks of treatment. However, the improvement for the highest AZD1981 dose (400 mg BID) vs placebo was not statistically significant (0.02 L,

conclusionIn patients with allergic asthma receiving ICS and LABA therapy, the addition of AZD1981 at doses up to 400 mg BID failed to produce a clinically relevant improvement in lung function or any other measured end point, but appeared to have an acceptable safety profile. This clinical study is registered with ClinicalTrials.gov (NCT01197794).

Indexed as

AcetatesAdministration, InhalationAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsAnti-Asthmatic AgentsAsthmaDouble-Blind MethodDrug Therapy, CombinationFemaleHumansIndolesMaleMiddle AgedReceptors, ImmunologicReceptors, ProstaglandinAcetatesAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsAnti-Asthmatic AgentsAZD1981Indolesprostaglandin D2 receptorReceptors, ImmunologicReceptors, Prostaglandinallergic asthmaAZD1981CRTh2 antagonistefficacyeosinophilssafety

Identifiers

PMID29765200
PMCPMC5942163
OpenAlexW2802493538

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.