Evidence map›Paper›PMID 33488071›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease

Comparison of Dry-Powder Inhaler and Pressurized Metered-Dose Inhaler Formulations of Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrronium in Patients with COPD: The TRI-D Randomized Controlled Trial.

Kai-Michael Beeh, Piotr Kuna, Massimo Corradi, Isabelle Viaud, Alessandro Guasconi, George Georges

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03590379 (A Phase II, Multicentre, Randomised, Double-blind, Double-dummy, Active-controlled, 3-way Cross-over Study to Evaluate the Efficacy of CHF 5993 Administered Via Dry Powder Inhaler), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing 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.

NCT03590379 phase2completednot on this map

A Phase II, Multicentre, Randomised, Double-blind, Double-dummy, Active-controlled, 3-way Cross-over Study to Evaluate the Efficacy of CHF 5993 Administered Via Dry Powder Inhaler (DPI) Versus CHF 5993 Via Pressurized Metered Dose Inhaler (pMDI) and CHF 1535 pMDI in Patients With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2018 to 2019Enrolled366ConditionsChronic Obstructive Pulmonary DiseaseArmsCHF 5993 DPI, CHF5993 pMDI, CHF 1535 pMDI, Placebo DPI, Placebo pMDI
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Observational
  11. Article
  12. Review
  13. Matching the Inhaler to the Patient in COPD.Journal of clinical medicine · 2021
    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 3 institutions in 2 countries.

Kai-Michael BeehInsaf Respiratory Research Institute, Wiesbaden, Germany.
Piotr KunaDivision of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Łódź, Poland.
Massimo CorradiDepartment of Medicine and Surgery, University of Parma, Parma, Italy.ORCID 0000-0002-2808-4184
Isabelle ViaudGlobal Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.
Alessandro GuasconiGlobal Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.
George GeorgesGlobal Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.ORCID 0000-0002-0303-2273
Chiesi (Italy) · ITRespiratory Research Institute · DEUniversity of Parma · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThree 52-week studies in COPD have assessed the efficacy and safety of single-inhaler extrafine formulation triple therapy combining beclomethasone dipropionate (BDP), formoterol fumarate (FF) and glycopyrronium (G) delivered via pressurized metered-dose inhaler (pMDI). BDP/FF/G is now being developed for delivery via multi-dose dry-powder inhaler (DPI; NEXThaler). This study aimed to demonstrate non-inferiority of BDP/FF/G DPI vs pMDI for lung function.

methodsMulticenter, randomized, double-blind, double-dummy, active-controlled, three-way cross-over study in patients with COPD and post-bronchodilator forced expiratory volume in 1 second (FEV

resultsOf 449 patients screened, 366 were randomized, with 342 (93.4%) completing all three treatment periods. The primary objectives were met, with changes from baseline in FEV

conclusionExtrafine BDP/FF/G DPI and pMDI demonstrated similar efficacy and safety in patients with COPD, supporting the DPI formulation as a valid alternative.

Indexed as

BeclomethasonePulmonary Disease, Chronic ObstructiveAdministration, InhalationBronchodilator AgentsCross-Over StudiesDouble-Blind MethodFormoterol FumarateFumaratesGlycopyrrolateHumansMetered Dose InhalersPowdersTreatment OutcomeBeclomethasoneBronchodilator AgentsFormoterol FumarateFumaratesGlycopyrrolatePowdersadrenergic beta-2 receptor agonistschronic obstructive pulmonary diseasemuscarinic antagonistsrespiratory function testssteroids

Identifiers

PMID33488071
PMCPMC7814657
OpenAlexW3120383455

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.