Evidence map›Paper›PMID 32962709›Full record

Trial reportRespiratory research2020

Efficacy and safety of CHF6001, a novel inhaled PDE4 inhibitor in COPD: the PIONEER study.

Dave Singh, Aida Emirova, Catherine Francisco, Debora Santoro, Mirco Govoni, Marie Anna Nandeuil

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02986321 (A 24-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF6001 DPI in Patients With COPD on a Background Therapy), which is not on this map. Cited by 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 pooled it
2.5field-weighted citation impact, top 8% 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.

NCT02986321 phase2completednot on this map

A 24-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF6001 DPI in Patients With COPD on a Background Therapy

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2016 to 2018Enrolled1,130ConditionsChronic Obstructive Pulmonary DiseaseArmsCHF6001, Budesonide, Placebo
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 3 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Article
  17. Review
  18. Emerging Anti-Inflammatory COPD Treatments: Potential Cardiovascular Impacts.International journal of chronic obstructive pulmonary disease · 2024
    Review
  19. Review
  20. 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

6 authors at 2 institutions in 2 countries.

Dave SinghMedicines Evaluation Unit, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK. dsingh@meu.org.uk.ORCID http://orcid.org/0000-0001-8918-7075
Aida EmirovaGlobal Clinical Development, Chiesi, Parma, Italy.
Catherine FranciscoGlobal Clinical Development, Chiesi, Parma, Italy.
Debora SantoroGlobal Clinical Development, Chiesi, Parma, Italy.
Mirco GovoniGlobal Clinical Development, Chiesi, Parma, Italy.
Marie Anna NandeuilGlobal Clinical Development, Chiesi, Parma, Italy.
Chiesi (Italy) · ITManchester University NHS Foundation Trust · GB

Funding

Chiesi Farmaceutici Not applicable
6 · The paper itself

Abstract

backgroundThis study evaluated the efficacy, safety and tolerability of the novel inhaled phosphodiesterase-4 inhibitor CHF6001 added-on to formoterol in patients with chronic obstructive pulmonary disease (COPD).

methodsRandomised, double-blind, placebo- and active-controlled, parallel-group study. Eligible patients had symptomatic COPD, post-bronchodilator forced expiratory volume in 1 s (FEV PRIMARY

objectivesTo investigate CHF6001 dose-response for pre-dose FEV

resultsOf 1130 patients randomised, 91.9% completed. Changes from baseline in pre-dose FEV

conclusionsCHF6001 had no effect in the primary lung function analysis, although was well-tolerated with no gastrointestinal adverse event signal. Post-hoc analyses focused on exacerbation risk indicate specific patient subgroups who may receive particular benefit from CHF6001.

trial registrationClinicalTrials.gov ( NCT02986321 ). Registered 8 Dec 2016.

Indexed as

Administration, InhalationAdultDouble-Blind MethodFemaleForced Expiratory VolumeHumansMaleMiddle Agedpara-AminobenzoatesPhosphodiesterase 4 InhibitorsPulmonary Disease, Chronic ObstructiveSulfonamidesTreatment Outcomepara-AminobenzoatesPhosphodiesterase 4 InhibitorsSulfonamidestanimilastAcute exacerbations of COPDChronic bronchitisChronic obstructive pulmonary diseasePhosphodiesterase inhibitors

Identifiers

PMID32962709
PMCPMC7510119
OpenAlexW3087901922

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.