Evidence map›Paper›PMID 19639035›Full record

ArticleThe open respiratory medicine journal2009

Safety of daily albuterol in infants with a history of bronchospasm: a multi-center placebo controlled trial.

James A Hedrick, James W Baker, Arthur B Atlas, Aftab A Naz, William R Lincourt, Roopa Trivedi, Anna Ellworth, Angela M Davis

Abstract read
In one paragraph

Article in The open respiratory medicine journal, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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. Article
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

8 authors.

James A HedrickKentucky Pediatric/Adult Research, 201 South 5 Street, Suite 102; Bardstown, Kentucky 40004, USA.
James W Baker
Arthur B Atlas
Aftab A Naz
William R Lincourt
Roopa Trivedi
Anna Ellworth
Angela M Davis

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInhaled short-acting bronchodilators are recommended for the quick relief of bronchospasm symptoms in children including those less than five years of age. However, limited safety data is available in this young population.

methodsSafety data were analyzed from a randomized, double-blind, parallel group, placebo-controlled multicenter, study evaluating albuterol HFA 90microg or 180microg versus placebo three times a day for 4 weeks using a valved holding chamber, Aerochamber Plus and facemask in children birth </=24 months old with a history of bronchospasm.

resultsTHE OVERALL INCIDENCE OF ADVERSE EVENTS (AE) DURING TREATMENT WAS: albuterol 90microg (59%), albuterol 180microg (76%) and placebo (71%). The most frequently reported AEs were pyrexia in 7 (24%), 2 (7%), and 3 (11%) subjects in the albuterol 180microg, albuterol 90microg, and placebo groups, respectively. Upper respiratory tract infection (URTI) occurred in 5 (17%) and 3 (11%) subjects in the albuterol 180microg and placebo groups, respectively. Sinus tachycardia occurred in 5 (17%), 2 (7%) and 2 (7%) subjects receiving albuterol 180microg, albuterol 90microg and placebo, respectively. One subject in each of the albuterol treatment groups experienced drug related agitation and/or restlessness or mild sinus arrhythmia. No drug-related QT prolongation or abnormal serum potassium and glucose levels were reported in the albuterol treatment groups.

conclusionThis study provides additional albuterol HFA safety information for the treatment of children aged birth </=24 months with a history of bronchospasm.

Identifiers

PMID19639035
PMCPMC2714526

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