Evidence map›Paper›PMID 30584293›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease

Indacaterol acetate/mometasone furoate provides sustained improvements in lung function compared with salmeterol xinafoate/fluticasone propionate in patients with moderate-to-very-severe COPD: results from a Phase II randomized, double-blind 12-week study.

Kai Michael Beeh, Anne-Marie Kirsten, Ana-Maria Tanase, Alexia Richard, Weihua Cao, Bettina Hederer, Jutta Beier, Oliver Kornmann, Richard N van Zyl-Smit

Open access · goldAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 16% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. 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

9 authors at 6 institutions in 4 countries.

Kai Michael BeehInsaf Respiratory Research Institute Wiesbaden, Wiesbaden, Germany, k.beeh@insaf-wi.de.
Anne-Marie KirstenPulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.
Ana-Maria TanaseNovartis Pharma AG, Basel, Switzerland.
Alexia RichardNovartis Pharma AG, Basel, Switzerland.
Weihua CaoNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Bettina HedererNovartis Pharma AG, Basel, Switzerland.
Jutta BeierInsaf Respiratory Research Institute Wiesbaden, Wiesbaden, Germany, k.beeh@insaf-wi.de.
Oliver KornmannIKF Pneumologie, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany.
Richard N van Zyl-SmitDivision of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.
Novartis (Switzerland) · CHRespiratory Research Institute · DEGerman Center for Lung Research · DEInstitute of Clinical Cancer Research · DENovartis (United States) · USUniversity of Cape Town · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeFixed-dose combinations of a long-acting beta agonist and an inhaled corticosteroid are more effective than the individual components in COPD. The primary study objective was to demonstrate that the combination indacaterol acetate/mometasone furoate (IND/MF [QMF149]) was non-inferior to the twice-daily combination salmeterol xinafoate/fluticasone propionate (Sal/Flu) in terms of trough FEV MATERIALS AND

methodsThis was a 12-week multicenter, randomized, double-blind, double-dummy, parallel-group, Phase II study in patients with moderate-to-very-severe COPD, who were randomized (1:1) to IND/MF (QMF149) (150/160 µg once daily; n=316) or Sal/Flu (50/500 µg twice daily; n=313).

resultsOver 90% of patients completed the study: 94.6% in the IND/MF (QMF149) group and 92.0% in the Sal/Flu group. The primary objective of non-inferiority of IND/MF (QMF149) to Sal/Flu for trough FEV

conclusionIND/MF (QMF149) (150/160 µg once daily) offered superior lung function and symptom efficacy and a favorable safety profile compared with Sal/Flu (50/500 µg twice daily) in patients with moderate-to-very severe COPD.

Indexed as

Adrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsAdultAgedBronchodilator AgentsDouble-Blind MethodDrug CombinationsFemaleFluticasone-Salmeterol Drug CombinationForced Expiratory VolumeHealth StatusHumansIndansLungMaleMiddle AgedAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsDrug CombinationsFluticasone-Salmeterol Drug Combinationindacaterol acetate-mometasone furoate drug combinationIndansMometasone FuroateQuinolonesCOPDfixed-combination inhalersindacaterolLABA/ICS combinationsmometasoneonce-daily inhalers

Identifiers

PMID30584293
PMCPMC6287650
OpenAlexW2903357761

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.