Evidence map›Paper›PMID 22978252›Full record

Trial reportBritish journal of clinical pharmacology2013

Pharmacokinetic comparison of inhaled fixed combination vs. the free combination of beclomethasone and formoterol pMDIs in asthmatic children.

Bo L K Chawes, Annalisa Piccinno, Eskil Kreiner-Møller, Nadja H Vissing, Porntiva Poorisrisak, Li Mortensen, Erik Nilson, Amalie Bisgaard, Anna Dossing, Maja Deleuran and 7 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01848769 (A Single-dose, Open-Label, 2-Way Cross-Over, Clinical Pharmacology Study Of Chf 1535 50/6 HFA pMDI), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 28% 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.

NCT01848769 phase2completednot on this map

A Single-dose, Open-Label, 2-Way Cross-Over, Clinical Pharmacology Study Of Chf 1535 50/6 HFA pMDI (Fixed Combination Of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6 µg) Using The Aerochamber Plus™ Spacer Device Versus The Free Combination Of Beclomethasone HFA pMDI And Formoterol HFA pMDI Available On The Market Using The Aerochamber Plus™ Spacer Device In Asthmatic Children

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2009 to 2010Enrolled20ConditionsAsthmaArmsCHF1535 pMDI + AC Plus, BDP + AC Plus, Formoterol + AC Plus
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. 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

17 authors at 5 institutions in 3 countries.

Bo L K ChawesCopenhagen University Hospital, Copenhagen Prospective Studies on Asthma in Childhood, Health Sciences, University of Copenhagen & Danish Pediatric Asthma Center, Gentofte, Denmark.
Annalisa Piccinno
Eskil Kreiner-Møller
Nadja H Vissing
Porntiva Poorisrisak
Li Mortensen
Erik Nilson
Amalie Bisgaard
Anna Dossing
Maja Deleuran
Nanna L Skytt
Nasim Samandari
Francesco Sergio
Giorgia Ciurlia
Gianluigi Poli
Daniela Acerbi
Hans Bisgaard
Copenhagen University Hospital · DKUniversity of Copenhagen · DKChiesi (Italy) · ITChiesi (France) · FRCopenhagen Prospective Studies on Asthma in Childhood · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe fixed combination of beclomethasone (BDP) and formoterol pressurized metered dose inhaler (pMDI) (Foster®, Chiesi Farmaceutici) is being developed in the lower strength (BDP/formoterol: 50/6 μg) to provide an appropriate dosage for children with asthma. The aim of this work was to investigate the systemic bioavailability of beclomethasone-17-monoproprionate (B17MP, the active metabolite of BDP) and formoterol after single inhalation of Foster® pMDI 50/6 μg vs. the free combination of BDP and formoterol pMDIs in asthmatic children.

methodsChildren aged 5-11 years old inhaled BDP 200 μg and formoterol 24 μg as fixed vs. free combination in an open label, randomized, two way crossover single dose study. Blood was collected pre-dose up to 8 h post-dose for pharmacokinetic evaluation (AUC(0,t), AUC(0,∞), AUC(0,0.5 h, Cmax , tmax , t1/2 ). Pharmacodynamics included heart rate, plasma potassium, urinary glucose and cortisol excretion. Peak expiratory flow and adverse events were monitored.

resultsTwenty subjects were evaluable. The systemic exposure of B17MP and formoterol administered as fixed combination did not exceed the free combination: B17MP AUC(0,t) (pg ml(-1)  h) ratio test : reference (90% CI), 0.81 (0.697, 0.948) and formoterol AUC(0,t) (pg ml(-1)  h) ratio test : reference 0.97 (0.85, 1.10). All pharmacokinetic and pharmacodynamic end points showed non-superiority in favour of the test drug. One adverse event (vertigo) occurred but was not considered treatment-related.

conclusionBDP and formoterol pharmacokinetic and pharmacodynamic effects are non-superior after administration of the two actives as fixed vs. the free combination in 5-11-year-old asthmatic children.

Indexed as

Administration, InhalationAnti-Asthmatic AgentsAsthmaBeclomethasoneBiological AvailabilityChildChild, PreschoolDrug CombinationsDrug Therapy, CombinationEthanolaminesFemaleFormoterol FumarateGlucoseHeart RateHumansHydrocortisoneAnti-Asthmatic AgentsBeclomethasoneDrug CombinationsEthanolaminesFormoterol FumarateGlucoseHydrocortisonePotassium

Identifiers

PMID22978252
PMCPMC3612726
OpenAlexW1591742666

What OpenQuestion holds

Textmetadata
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.