Evidence map›Paper›PMID 31399091›Full record

Trial reportRespiratory research2019

Effect of the inhaled PDE4 inhibitor CHF6001 on biomarkers of inflammation in COPD.

Dave Singh, Kai Michael Beeh, Brendan Colgan, Oliver Kornmann, Brian Leaker, Henrik Watz, Germano Lucci, Silvia Geraci, Aida Emirova, Mirco Govoni and 1 more

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

Trial report in Respiratory research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03004417 (A Randomised, Double-blind,Placebo Controlled, Repeated Dose, Three-way Crossover Study to Evaluate the Pharmacodynamics, Pharmacokinetics and Safety of Two Doses of CHF6001 DPI in Subjects With Moderate, Severe COPD), which is not on this map. Cited by 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
8.7field-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.

NCT03004417 phase2completednot on this map

A Randomised, Double-blind,Placebo Controlled, Repeated Dose, Three-way Crossover Study to Evaluate the Pharmacodynamics, Pharmacokinetics and Safety of Two Doses of CHF6001 DPI in Subjects With Moderate, Severe COPD

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2016 to 2017Enrolled61ConditionsCOPDArmsCHF 6001 Dose1, CHF 6001 Dose2, Placebo
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 77 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Induced sputum: current progress and prospect.European journal of medical research · 2025
    Review
  10. Article
  11. Review
  12. Article
  13. Burden of Exacerbations in Patients Newly Initiating an Inhaled Regimen for COPD: A Claims Analysis.International journal of chronic obstructive pulmonary disease · 2025
    Article
  14. Review
  15. Review
  16. Article
  17. Review
  18. Article
  19. Article
  20. Clinical Implication of Phosphodiesterase-4-Inhibition.International journal of molecular sciences · 2022
    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

11 authors at 5 institutions in 3 countries.

Dave SinghMedicines Evaluation Unit, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.
Kai Michael BeehInsaf Respiratory Research Institute, Wiesbaden, Germany.
Brendan ColganCelerion, Belfast, UK.
Oliver KornmannIKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany.
Brian LeakerThe Heart Lung Centre, London, UK.
Henrik WatzPulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany.
Germano LucciGlobal Clinical Development, Chiesi, Parma, Italy.
Silvia GeraciGlobal Clinical Development, Chiesi, Parma, Italy.
Aida EmirovaGlobal Clinical Development, Chiesi, Parma, Italy.
Mirco GovoniGlobal Clinical Development, Chiesi, Parma, Italy. M.Govoni@chiesi.com.ORCID http://orcid.org/0000-0002-7834-7237
Marie Anna NandeuilGlobal Clinical Development, Chiesi, Parma, Italy.
Chiesi (Italy) · ITCelerion (United Kingdom) · GBGerman Center for Lung Research · DEManchester University NHS Foundation Trust · GBRespiratory Research Institute · DE

Funding

Chiesi Farmaceutici Not applicable
6 · The paper itself

Abstract

backgroundCHF6001 is a novel inhaled phosphodiesterase-4 inhibitor. This Phase IIa study assessed the effects of CHF6001 on markers of inflammation in induced sputum and blood in patients with chronic obstructive pulmonary disease (COPD).

methodsThis was a multicentre, three-period (each 32 days), three-way, placebo-controlled, double-blind, complete-block crossover study. Eligible patients had COPD, chronic bronchitis, and were receiving inhaled triple therapy for ≥2 months. Patients received CHF6001 800 or 1600 μg, or matching placebo twice daily via multi-dose dry-powder inhaler (NEXThaler). Induced sputum was collected pre-dose on Day 1, and post-dose on Days 20, 26 and 32. Blood was sampled pre-dose on Day 1, and pre- and post-dose on Day 32.

resultsOf 61 randomised patients, 54 (88.5%) completed the study. There were no significant differences between groups for overall sputum cell count, or absolute numbers of neutrophils, eosinophils or lymphocytes. CHF6001 800 μg significantly decreased the absolute number and percentage of macrophages vs placebo. In sputum, compared with placebo both CHF6001 doses significantly decreased leukotriene B4, C-X-C motif chemokine ligand 8, macrophage inflammatory protein 1β, matrix metalloproteinase 9, and tumour necrosis factor α (TNFα). In blood, both CHF6001 doses significantly decreased serum surfactant protein D vs placebo. CHF6001 1600 μg significantly decreased TNFα ex-vivo (after incubation with lipopolysaccharide).

conclusionThe data from this study show that CHF6001 inhaled twice daily has anti-inflammatory effects in the lungs of patients with COPD already treated with triple inhaled therapy.

trial registrationThe study is registered on ClinicalTrials.gov ( NCT03004417 ).

Indexed as

AgedBiomarkersBronchodilator AgentsCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansInflammationInflammation MediatorsMaleMiddle Agedpara-AminobenzoatesPhosphodiesterase 4 InhibitorsPulmonary Disease, Chronic ObstructiveSputumBiomarkersBronchodilator AgentsInflammation Mediatorspara-AminobenzoatesPhosphodiesterase 4 InhibitorsSulfonamidestanimilastChronic obstructive pulmonary diseaseInduced sputumInflammationPharmacologyPhosphodiesterase 4 inhibitors

Identifiers

PMID31399091
PMCPMC6688371
OpenAlexW2968283804

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.