Evidence map›Paper›PMID 27104231›Full record

ArticleJournal of aerosol medicine and pulmonary drug delivery2016

Long-Term Fluticasone Propionate/Formoterol Fumarate Combination Therapy Is Associated with a Low Incidence of Severe Asthma Exacerbations.

Alberto Papi, Adel H Mansur, Tetyana Pertseva, Kirsten Kaiser, Tammy McIver, Birgit Grothe, Sanjeeva Dissanayake

Open access · hybridAbstract read
In one paragraph

Article in Journal of aerosol medicine and pulmonary drug delivery, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 11% 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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Systematic Literature Review of Systemic Corticosteroid Use for Asthma Management.American journal of respiratory and critical care medicine · 2020
    Pooled it
  3. Trial
  4. Fluticasone propionate/formoterol for COPD management: a randomized controlled trial.International journal of chronic obstructive pulmonary disease · 2017
    Trial
  5. Trial
  6. Trial
  7. Review
  8. Observational
  9. Article
  10. Article
  11. Article
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  14. Observational
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

7 authors at 3 institutions in 3 countries.

Alberto Papi1 Research Centre on Asthma and COPD, University of Ferrara , Ferrara, Italy .
Adel H Mansur2 Chest Research Institute, Birmingham Heartlands Hospital , Birmingham, United Kingdom .
Tetyana Pertseva3 Dnipropetrovsk State Medical Academy , Dnipropetrovsk, Ukraine .
Kirsten Kaiser4 Medicinal and Regulatory Development , Skyepharma AG, Muttenz, Switzerland .
Tammy McIver5 Clinical Data Management and Statistics, Mundipharma Research Limited , Cambridge, United Kingdom .
Birgit Grothe6 Medical Science-Respiratory, Mundipharma Research Limited , Cambridge, United Kingdom .
Sanjeeva Dissanayake6 Medical Science-Respiratory, Mundipharma Research Limited , Cambridge, United Kingdom .
Dnipropetrovsk State Medical Academy · UAMundipharma (United Kingdom) · GBUniversity of Ferrara · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA primary goal of asthma management is the reduction of exacerbation risk. We assessed the occurrence of oral corticosteroid-requiring exacerbations (OCS exacerbations) with long-term fluticasone/formoterol therapy, and compared it with the occurrence of similar events reported with other inhaled corticosteroid/long acting β2-agonist (ICS/LABA) combinations.

methodsThe occurrence of OCS exacerbations was assessed in two open-label trials of fixed-dose fluticasone/formoterol administered for between 26 to 60 weeks in adults and adolescents with asthma. The incidence of OCS exacerbations with fluticasone/formoterol was compared with those reported in three recent Cochrane meta-analyses of other ICS/LABAs.

resultsThe pooled incidence of OCS exacerbations with long-term fluticasone/formoterol was 2.1% (95% CI: 1.1, 3.2%, n/N = 16/752). In only two of the nineteen treatment arms summarized by Cochrane did OCS exacerbation incidence approximate that seen in the two fluticasone/formoterol trials (single-inhaler fluticasone/salmeterol [2.9%]; separate inhaler budesonide, beclometasone, or flunisolide plus formoterol [3.4%]). In Lasserson's review the pooled incidence of OCS exacerbations for single-inhaler combinations was 9.5% (95% CI: 8.4, 10.6%; n/N = 239/2516) for fluticasone/salmeterol, and 10.6% (95% CI: 9.3, 11.8%; n/N = 257/2433) for budesonide/formoterol. In Ducharme's and Chauhan's meta-analyses (primarily incorporating separate inhaler combinations [fluticasone, budesonide, beclometasone, or flunisolide plus salmeterol or formoterol]), the pooled incidences of OCS exacerbations were 16.0% (95% CI: 14.2, 17.8%, n/N = 258/1615) and 16.7% (95% CI: 14.9, 18.5, n/N = 275/1643), respectively.

conclusionsThe incidence of exacerbations in two fixed-dose fluticasone/formoterol studies was low and less than in the majority of comparable published studies involving other ICS/LABA combinations. This difference could not be readily explained by differences in features of the respective studies and may be related to the favorable pharmacological/mechanistic characteristics of the constituent components fluticasone and formoterol compared to other drugs in their respective classes.

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsAdultAndrostadienesAnti-Asthmatic AgentsAsthmaBronchodilator AgentsClinical Trials as TopicDisease ProgressionDrug CombinationsEthanolaminesFemaleFluticasoneFormoterol FumarateGlucocorticoidsHumansAdrenergic beta-2 Receptor AgonistsAndrostadienesAnti-Asthmatic AgentsBronchodilator AgentsDrug CombinationsEthanolaminesFluticasonefluticasone-formoterolFormoterol FumarateGlucocorticoidsasthmafluticasone/formoterolfluticasone propionateflutiform®formoterolsevere exacerbations

Identifiers

PMID27104231
PMCPMC4965704
OpenAlexW2407210537

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.