Evidence map›Paper›PMID 21240480›Full record

Trial reportEuropean journal of clinical pharmacology2011

Comparative lung bioavailability of fluticasone/salmeterol via a breath-actuated spacer and conventional plastic spacers.

Arun Nair, Lorna McKinlay, Peter Williamson, Philip Short, Patricia Burns, Brian J Lipworth

Erratum issued Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01194700 (Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 31% 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.

NCT01194700 phase4completednot on this map

Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers

TypeinterventionalSponsorBrian J LipworthRan2009 to 2009Enrolled19ConditionsAsthmaArmsSeretide 250(8puffs) via Evohaler actuator, Seretide 250 (8 puffs)/placebo via Volumatic spacer, Seretide 250/placebo 8 puffs via Aerochamber Plus spacer, Seretide 250/placebo via Synchro-Breathe
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Arun NairAsthma & Allergy Research Group, Division of Medical Sciences, Ninewells Hospital & Medical School, University of Dundee, Dundee, Scotland, DD1 9SY.
Lorna McKinlayAsthma & Allergy Research Group, Division of Medical Sciences, Ninewells Hospital & Medical School, University of Dundee, Dundee, Scotland, DD1 9SY.
Peter WilliamsonAsthma & Allergy Research Group, Division of Medical Sciences, Ninewells Hospital & Medical School, University of Dundee, Dundee, Scotland, DD1 9SY.
Philip ShortAsthma & Allergy Research Group, Division of Medical Sciences, Ninewells Hospital & Medical School, University of Dundee, Dundee, Scotland, DD1 9SY.
Patricia BurnsAsthma & Allergy Research Group, Division of Medical Sciences, Ninewells Hospital & Medical School, University of Dundee, Dundee, Scotland, DD1 9SY.
Brian J LipworthAsthma & Allergy Research Group, Division of Medical Sciences, Ninewells Hospital & Medical School, University of Dundee, Dundee, Scotland, DD1 9SY. brianlipworth@googlemail.com.
Ninewells Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study compares the in vivo relative lung bioavailability of Hydrofluoroalkane (HFA) Seretide delivered via unprimed and unwashed Aerochamber Plus (AP) or Volumatic (VM) spacers, a integrated breath-actuated vortex Synchro-Breathe (SB) device and an Evohaler pMDI (EH) device using adrenal suppression and early fall in serum potassium (K) as surrogates for respirable dose.

methodsSeventeen healthy volunteers completed this randomised double-blind, double-dummy crossover study. Single doses of placebo/Seretide 250 (total dose ex valve fluticasone 2000 mcg/salmeterol 200 mcg) were administered via the devices. Overnight urinary cortisol/creatinine (OUCC) and serum K were measured at baseline and after each dose.

resultsSignificant suppression of OUCC and K occurred from baseline with the SB, AP and VM but not with the EH devices. The geometric mean fold suppression (95% confidence interval, p) was: EH, 1.59 (0.80-3.14, p=0.40); AP, 4.26 (3.01-6.02, p<0.001); VM, 3.11 (1.99-4.78, p<0. 001); SB, 3.29 (2.04-5.24, p<0.001). For K, the arithmetic mean fall (mmol/l) (95% confidence interval; p) was: EH, -0.10 (-0.25-0.05, p=0.18); AP, -0.23 (-0.41 to -0.04, p=0.02); VM, -0.22 (-0.44 to -0.01, p=0.04); SB, -0.28 (-0.42 to -0.13, p=0.001).

conclusionsThe breath-actuated SB device was comparable to 'out of the box' small and large volume spacers and produced similar improvements in relative systemic lung bioavailability for fluticasone and salmeterol.

Indexed as

Inhalation SpacersAdministration, InhalationAdultAlbuterolAndrostadienesBiological AvailabilityCreatinineCross-Over StudiesDouble-Blind MethodDrug CombinationsFemaleFluticasone-Salmeterol Drug CombinationHumansHydrocortisoneLungMaleAlbuterolAndrostadienesCreatinineDrug CombinationsFluticasone-Salmeterol Drug CombinationHydrocortisonePotassium

Identifiers

PMID21240480
OpenAlexW4252780150

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.