Evidence map›Paper›PMID 33413291›Full record

ArticleBMC pulmonary medicine2021

Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate administered as an inhaled fixed-dose combination in Japanese and Caucasian healthy subjects.

Satoru Inoue, Soniya Vaidya, Hanns-Christian Tillmann, Yohei Sakita, Surendra Machineni, Olivier Heudi, Kenichi Furihata

Open access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in BMC pulmonary medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 29% 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

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. 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 6 institutions in 4 countries.

Satoru InoueNovartis Pharma KK, Tokyo, Japan. satoru-1.inoue@novartis.com.
Soniya VaidyaNovartis Institutes for BioMedical Research, Cambridge, USA.
Hanns-Christian TillmannNovartis Institutes for BioMedical Research, Basel, Switzerland.
Yohei SakitaNovartis Pharma KK, Tokyo, Japan.
Surendra MachineniNovartis Healthcare Pvt. Ltd., Hyderabad, India.
Olivier HeudiNovartis Institutes for BioMedical Research, Basel, Switzerland.
Kenichi FurihataP-One Clinic, Keikokai Medical Corporation, Tokyo, Japan.
Novartis (Japan) · JPKishokai Medical Corporation · JPNovartis (India) · INNovartis Institutes for BioMedical ResearchNovartis (Switzerland) · CHNovartis (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA once-daily (o.d.) fixed-dose combination of indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF) delivered via the Breezhaler

methodsThis was a single-center, open-label, 2-treatment crossover study with a 21-day washout period. Japanese and Caucasian subjects received IND/GLY/MF 150/50/80 μg (inhaled corticosteroid [ICS] medium-dose) or 150/50/160 μg o.d. (ICS high-dose) for 14 days in each period. Pharmacokinetics were characterized up to 24 h post-dose on Days 1 and 14.

resultsIn total, 16 Japanese (median age 31 years [range 20-40 years], mean weight 68.3 kg) and 17 Caucasian subjects (median age 27 years [range 21-43 years], mean weight 75.0 kg) were randomized. Geometric mean ratios (Japanese/Caucasian) [90% confidence interval (CI)] for C

conclusionPharmacokinetics of IND, GLY and MF (high and medium dose) when delivered as a fixed-dose combination were comparable between Japanese and Caucasian subjects. The IND/GLY/MF combination at the administrated doses was safe and well tolerated in both ethnic groups.

trial registrationJapan Registry of Clinical Trial: jRCT2031200227, retrospectively registered on 04, December, 2020.

Indexed as

Administration, InhalationAdultAnti-Asthmatic AgentsAsian PeopleCross-Over StudiesDrug CombinationsFemaleGlycopyrrolateHealthy VolunteersHumansIndansMaleMometasone FuroateQuinolonesWhite PeopleYoung AdultAnti-Asthmatic AgentsDrug CombinationsGlycopyrrolateindacaterolIndansMometasone FuroateQuinolonesAsthmaIndacaterol/glycopyrronium/mometasone furoateJapanese–CaucasianPharmacokinetics

Identifiers

PMID33413291
PMCPMC7791651
OpenAlexW3120136698

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Registered trials

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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.