Evidence map›Paper›PMID 33404895›Full record

Trial reportEuropean journal of pediatrics2021

Bronchodilating effects of a new beclometasone dipropionate plus formoterol fumarate formulation via pressurized metered-dose inhaler in asthmatic children: a double-blind, randomized, cross-over clinical study.

Petr Pohunek, Guido Varoli, Yuriy Reznichenko, Svetlana Mokia-Serbina, Jerzy Brzostek, Viktoriya Kostromina, Mykola Kaladze, Annamaria Muraro, Elena Carzana, Silvia Armani and 1 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of pediatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact, top 99% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 0 citations in OpenAlex.

  1. Pooled it
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 8 institutions in 6 countries.

Petr PohunekPaediatric Department, University Hospital Motol, V Uvalu 84, 150 06, Praha, Czech Republic. petr.pohunek@LFMotol.cuni.cz.ORCID https://orcid.org/0000-0003-4557-2515
Guido VaroliGlobal Clinical Development, Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy.
Yuriy ReznichenkoPulmonology Department of Community Institution "Zaporizhzhya Regional Clinical Child Hospital" of Zaporizhzhya Regional Council, Zaporizhzhya State Medical University, 70 Lenina str, Zaporizhzhya, 69063, Ukraine.
Svetlana Mokia-SerbinaCity Clinical Hospital № 8, 55, 23rd Lyutogo str., Kryvyi Rog, Ukraine.
Jerzy BrzostekPoradnia Alergologiczna, ZOZ Debica, ul., Krakowska 91, 39-200, Debica, Poland.
Viktoriya KostrominaDepartment of Child Pulmonology and Allergology, State Institution "National Institute of Physiatry and Pulmonology n.a. F.G. Yanovskyy of AMS of Ukraine", 10, Amosova str., Kyiv, 03680, Ukraine.
Mykola Kaladze1st City Children Clinical Association of Simferopol City, Department of Pulmonology, Simferopol, Department of Pediatry with Physiotherapy Course of Faculty of Postgraduate Education, State Institution "Crimean State Medical University n.a. S.I. Georgiyivskiy", 31, K. Libknehta, Simferopol, Crimea, Russia.
Annamaria MuraroGlobal Clinical Development, Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy.
Elena CarzanaGlobal Clinical Development, Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy.
Silvia ArmaniGlobal Clinical Development, Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy.
Jadwiga KaczmarekOutpatient Clinic of Allergology, Kopcinskiego Str 22, 90-153, Lodz, Poland.
Chiesi Foundation · ITAmosov National Institute of Cardiovascular Surgery · UAKryvyi Rih State Pedagogical University · UAMedical University of Lodz · PLOgród Zoologiczny w Krakowie · PLResearch Institute of Agriculture of Crimea · RUUniversity Hospital in Motol · CZZaporizhzhia State Medical and Pharmaceutical University · UA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A new pediatric fixed combination of beclometasone dipropionate (BDP) 50 μg and formoterol fumarate (FF) 6 μg via pressurized metered-dose inhaler (pMDI) (CHF1535, Chiesi, Italy) was investigated. In a double-blind, randomized, placebo-controlled, cross-over study, a single CHF1535 administration using AeroChamber Plus™ spacer device (2 actuations, total dose BDP 100 μg/FF 12 μg) was compared to the same pMDI free combination in 56 asthmatic children aged ≥ 5 and < 12 years. Primary efficacy variable was forced expiratory volume during the first second (FEV

Indexed as

Anti-Asthmatic AgentsAsthmaAdministration, InhalationBeclomethasoneBronchodilator AgentsChildCross-Over StudiesDouble-Blind MethodDrug CombinationsForced Expiratory VolumeFormoterol FumarateHumansItalyMetered Dose InhalersNebulizers and VaporizersTreatment OutcomeAnti-Asthmatic AgentsBeclomethasoneBronchodilator AgentsDrug CombinationsFormoterol FumarateBeclometasoneFixed combinationFormoterolPediatric asthmaPressurized metered-dose inhaler

Identifiers

PMID33404895
OpenAlexW3119974593

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.