Evidence map›Paper›PMID 25248764›Full record

Trial reportRespiratory research2014

Fluticasone propionate/salmeterol 250/50 μg versus salmeterol 50 μg after chronic obstructive pulmonary disease exacerbation.

Jill A Ohar, Glenn D Crater, Amanda Emmett, Thomas J Ferro, Andrea N Morris, Ibrahim Raphiou, Peruvemba S Sriram, Mark T Dransfield

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01110200 (A Randomized, Double-Blind, Parallel Group, Multicenter Study of the Effects of Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID), which is not on this map. Cited by 13 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 5 pooled it
2.2field-weighted citation impact, top 12% 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.

NCT01110200 phase4completednot on this map

A Randomized, Double-Blind, Parallel Group, Multicenter Study of the Effects of Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID (ADVAIR DISKUS™) in Comparison to Salmeterol 50mcg BID (SEREVENT DISKUS™) on the Rate of Exacerbations of COPD Following Hospitalization

TypeinterventionalSponsorGlaxoSmithKlineRan2010 to 2012Enrolled639ConditionsPulmonary Disease, Chronic ObstructiveArmsADVAIR DISKUS 250/50 mg BID, SEREVENT 50 mcg BID
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 5 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Inhaled corticosteroids and FEVRespiratory research · 2019
    Pooled it
  5. Pooled it
  6. Discordant diagnostic criteria for pneumonia in COPD trials: a review.European respiratory review : an official journal of the European Respiratory Society · 2021
    Review
  7. Review
  8. COPD from an everyday primary care point of view.Journal of family medicine and primary care · 2019
    Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. 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

8 authors at 5 institutions in 1 country.

Jill A OharWake Forest University Medical Center, 1 Medical Center Boulevard, Winston-Salem, NC, USA. johar@wakehealth.edu.
Glenn D Crater
Amanda Emmett
Thomas J Ferro
Andrea N Morris
Ibrahim Raphiou
Peruvemba S Sriram
Mark T Dransfield
GlaxoSmithKline (United States) · USResearch Triangle Park Foundation · USUniversity Medical Center · USUniversity of Alabama at Birmingham · USUniversity of Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInhaled long-acting beta2 agonists used alone and in combination with an inhaled corticosteroid reduce the risk of exacerbations in patients with stable COPD. However, the relative efficacy of these agents in preventing recurrent exacerbations in those recovering from an initial episode is not known. This study compared the rate of COPD exacerbations over the 26 weeks after an initial exacerbation in patients receiving the combination of fluticasone propionate and salmeterol (FP/SAL) or SAL alone.

methodsPatients (n = 639) aged ≥40 years were randomized to either twice-daily inhaled FP/SAL 250/50 μg or SAL 50 μg. Primary, and secondary, endpoints were rates of recurrent severe, and moderate/severe, exacerbations of COPD. Lung function, health outcomes and levels of biomarkers of systemic inflammation were also assessed.

resultsThere was no statistically significant treatment difference in rates of recurrent severe exacerbations (treatment ratio 0.92 [95% CI: 0.58, 1.45]) and moderate/severe exacerbations (0.82 [0.64, 1.06]) between FP/SAL and SAL in the intent-to-treat population. Pre-dose morning FEV1 change from baseline was greater (0.10 L [0.04, 0.16]) with FP/SAL than SAL. No treatment difference was seen for other endpoints including patient-reported health outcomes and biomarker levels for the full cohort.

conclusionsNo significant treatment difference between FP/SAL and SAL was seen in COPD exacerbation recurrence for the complete cohort. Treatment benefit with FP/SAL over SAL (treatment ratio 0.68 [0.47, 0.97]) was seen in patients having FEV1 ≥ 30% and prior exposure to ICS. No unexpected safety issues were identified with either treatment. Patients with the most severe COPD may be more refractory to treatment.

trial registrationClinicalTrials.gov (identifier NCT01110200). This study was funded by GlaxoSmithKline (study number ADC113874).

Indexed as

Disease ProgressionAdministration, InhalationAgedAlbuterolAndrostadienesBronchodilator AgentsDouble-Blind MethodDrug CombinationsFemaleFluticasone-Salmeterol Drug CombinationHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveSalmeterol XinafoateAlbuterolAndrostadienesBronchodilator AgentsDrug CombinationsFluticasone-Salmeterol Drug CombinationSalmeterol Xinafoate

Identifiers

PMID25248764
PMCPMC4176847
OpenAlexW2099226604

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.