Evidence map›Paper›PMID 25649209›Full record

Trial reportBMJ open2015

Effect of once-daily indacaterol maleate/mometasone furoate on exacerbation risk in adolescent and adult asthma: a double-blind randomised controlled trial.

Richard W Beasley, James F Donohue, Rajendra Mehta, Harold S Nelson, Michelle Clay, Allen Moton, Han-Joo Kim, Bettina M Hederer

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

Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00941798 (A Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler®), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 15% 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.

NCT00941798 phase2completednot on this map

A Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler® (500/400 µg) and Mometasone Furoate Twisthaler® (400 µg) in Adolescent and Adult Patients With Persistent Asthma

TypeinterventionalSponsorNovartis PharmaceuticalsRan2009 to 2011Enrolled2,283ConditionsAsthmaArmsQMF149 Twisthaler®, Mometasone Twisthaler®
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Article
  8. Positioning new pharmacotherapies for COPD.International journal of chronic obstructive pulmonary disease · 2015
    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 6 institutions in 4 countries.

Richard W BeasleyMedical Research Institute of New Zealand, Wellington, New Zealand.
James F DonohueDepartment of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
Rajendra MehtaDr Mehta's Allergy & Asthma Care and Research Center, Indore, Madhya Pradesh, India.
Harold S NelsonNational Jewish Health, Denver, Colorado, USA.
Michelle ClayNovartis Horsham Research Centre, Horsham, West Sussex, UK.
Allen MotonNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Han-Joo KimNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Bettina M HedererNovartis Pharmaceuticals Corporation, Basel, Switzerland.
Novartis (United States) · USMedical Research Institute of New Zealand · NZNational Jewish Health · USNovartis (Switzerland) · CHNovartis (United Kingdom) · GBUniversity of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the safety and efficacy of QMF149, a once-daily, fixed-dose combination of the long-acting β2-agonist (LABA) indacaterol maleate and inhaled corticosteroid (ICS) mometasone furoate (MF) for the treatment of persistent asthma. The hypothesis was that QMF149 would not increase the risk of serious asthma exacerbations.

setting174 research centres in nine countries.

participants1519 adolescents and adults with persistent asthma who were treated or qualified for treatment with combination LABA/ICS were randomised, and 1508 were included in the intention-to-treat analysis.

interventionPatients were randomised to QMF149 (indacaterol maleate 500 µg/MF 400 µg) or MF (400 µg) once daily via Twisthaler inhalation device in a double-blind, parallel-group study for 6-21 months. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary end point was time to first serious asthma exacerbation (resulting in hospitalisation, intubation or death). The key secondary end point was annual rate of exacerbations requiring systemic corticosteroids.

resultsTreatment with QMF149 resulted in no significant difference in time to first serious exacerbation compared to MF (2 (0.3%) vs 6 events (0.8%); difference -0.52 percentage point; 95% CI -1.25 to 0.21, p=0.160, HR=0.31; 95% CI 0.06 to 1.54, p=0.151). QMF149 significantly reduced the annual rate of exacerbations requiring systemic corticosteroids (rate ratio=0.71; 95% CI 0.55 to 0.90, p=0.005). Proportions of patients experiencing adverse events were similar across groups (74.0% in the QMF149 group and 73.4% in the MF group). Serious adverse events occurred in 4% and 5.8% of patients in the QMF149 and MF groups, respectively.

conclusionsNo significant difference was observed in the primary outcome of time to first serious asthma exacerbation in patients treated with QMF149 compared with patients treated with MF. Long-term treatment with QMF149 once daily had a favourable safety/efficacy profile in adolescent and adult patients with persistent asthma. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov; NCT00941798.

Indexed as

Disease ProgressionAdministration, InhalationAdolescentAdrenal Cortex HormonesAdrenergic beta-AgonistsAdultAgedAnti-Allergic AgentsAnti-Asthmatic AgentsAsthmaDouble-Blind MethodDrug Therapy, CombinationFemaleHumansIndansMaleAdrenal Cortex HormonesAdrenergic beta-AgonistsAnti-Allergic AgentsAnti-Asthmatic AgentsindacaterolIndansMaleatesMometasone FuroatePregnadienediolsQuinolonesCLINICAL PHARMACOLOGY

Identifiers

PMID25649209
PMCPMC4322191
OpenAlexW2012420530

What OpenQuestion holds

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LicenceCC BY-NC
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.