Evidence map›Paper›PMID 22334769›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2012

Effects of mometasone furoate/formoterol fumarate fixed-dose combination formulation on chronic obstructive pulmonary disease (COPD): results from a 52-week Phase III trial in subjects with moderate-to-very severe COPD.

Dennis E Doherty, Donald P Tashkin, Edward Kerwin, Barbara A Knorr, Tulin Shekar, Sibabrata Banerjee, Heribert Staudinger

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 10 pooled it
5.9field-weighted citation impact, top 4% 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

22 citing papers in PubMed, 10 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
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  9. Long-acting beta2-agonists for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2013
    Pooled it
  10. Pooled it
  11. Trial
  12. Discordant diagnostic criteria for pneumonia in COPD trials: a review.European respiratory review : an official journal of the European Respiratory Society · 2021
    Review
  13. Review
  14. Review
  15. Impact and prevention of severe exacerbations of COPD: a review of the evidence.International journal of chronic obstructive pulmonary disease · 2017
    Review
  16. Article
  17. Relationship Between FEVChronic obstructive pulmonary diseases (Miami, Fla.) · 2016
    Article
  18. Review
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  20. 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

7 authors at 4 institutions in 1 country.

Dennis E DohertyDivision of Pulmonary, Critical Care, and Sleep Medicine, University of Kentucky, Lexington, KY 40536, USA. dedohe0@email.uky.edu
Donald P Tashkin
Edward Kerwin
Barbara A Knorr
Tulin Shekar
Sibabrata Banerjee
Heribert Staudinger
Merck & Co., Inc., Rahway, NJ, USA (United States) · USClinical Research Institute · USUniversity of California, Los Angeles · USUniversity of Kentucky · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleThe purpose of this study was to investigate the clinical efficacy and safety of a fixed-dose combination of mometasone furoate/formoterol fumarate (MF/F) administered via a metered-dose inhaler in subjects with moderate-to-very severe chronic obstructive pulmonary disease (COPD).

methodsThis multicenter, double-blind, placebo-controlled trial had a 26-week treatment period and a 26-week safety extension. Subjects (n = 1196), at least 40 years old, were current or ex-smokers randomized to twice-daily inhaled MF/F 400/10 μg, MF/F 200/10 μg, MF 400 μg, F 10 μg, or placebo. The trial's co-primary endpoints were mean changes from baseline, as area under the curve (AUC), in forced expiratory volume (FEV(1)) over 0-12 hours (AUC(0-12 h) FEV(1)) with MF/F versus MF, and in morning (AM) pre-dose (trough) FEV(1) with MF/F versus F after 13 weeks of treatment. Key secondary endpoints were the effects of MF/F on respiratory health status using the Saint George's Respiratory Questionnaire (SGRQ), symptom-free nights, partly stable COPD at 26 weeks, and time to first COPD exacerbation.

resultsThe largest improvements in AUC(0-12 h) FEV(1) were observed with MF/F 400/10 μg and MF/F 200/10 μg. Serial spirometry results demonstrated that bronchodilator effects with MF/F occurred rapidly (within 5 minutes), persisted for 12 hours after dosing, and were sustained over the 26-week treatment period. Similar findings were observed for AM pre-dose FEV(1), for which effects were further investigated, excluding subjects whose AM FEV(1) data were incorrectly collected after 2 days from the last dose of study treatment. Improvements in SGRQ scores surpassed the minimum clinically important difference of more than four units with both MF/F treatments. At 26 weeks, no notable between-treatment differences in the occurrence and nature of adverse events (AEs) were reported. No unexpected AEs were observed. Overall, 90 subjects reported AEs considered to be treatment-related, the most common of which were lenticular opacities, dysphonia, and oral candidiasis. DISCUSSION: In conclusion, MF/F treatments improved lung function and respiratory health status, reduced exacerbations, and were well tolerated in subjects with moderate-to-very severe COPD.

Indexed as

Administration, InhalationAdultArea Under CurveBronchodilator AgentsDouble-Blind MethodDrug Administration ScheduleDrug CombinationsEthanolaminesFemaleFormoterol FumarateHumansMaleMetered Dose InhalersMiddle AgedMometasone FuroatePregnadienediolsBronchodilator AgentsDrug CombinationsEthanolaminesFormoterol FumarateMometasone FuroatePregnadienediolsbronchodilatorCOPDexacerbationFEV1inhaled corticosteroidspirometry

Identifiers

PMID22334769
PMCPMC3276257
OpenAlexW2005287318

What OpenQuestion holds

Textmetadata
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.