Evidence map›Paper›PMID 37682405›Full record

Trial reportClinical drug investigation2023

Efficacy, Safety, and Systemic Exposure of Once-Daily Indacaterol Acetate in Pediatric Asthma: A Randomized, Double-Blind, Controlled Dose-Finding Study.

Bulent Enis Sekerel, Haylene Nell, Istvan Laki, Tatiana Pak, Edgar Contreras, Adam Kolarz, Peter D'Andrea, Volkan Manga, Monish Jain, Soniya Vaidya and 2 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Clinical drug investigation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02892019 (A Multicenter, Randomized, Double-blind, Active-controlled, 2 Week Treatment, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 39% 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.

NCT02892019 phase2completednot on this map

A Multicenter, Randomized, Double-blind, Active-controlled, 2 Week Treatment, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma

TypeinterventionalSponsorNovartis PharmaceuticalsRan2017 to 2019Enrolled79ConditionsAsthmaArmsIndacaterol acetate 75 μg, Indacaterol acetate 150 μg
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
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

12 authors at 6 institutions in 6 countries.

Bulent Enis SekerelPediatric Allergy and Asthma Division, Hacettepe University Faculty of Medicine, Ankara, Turkey. b_sekerel@yahoo.com.
Haylene NellTiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa.
Istvan LakiDepartment of Pediatric Pulmonology, Institute of Pulmonology, Törökbálint, Hungary.
Tatiana PakLLC PiterClinica, Saint-Petersburg, Russian Federation.
Edgar ContrerasMédico Neumólogo e Internista, Director del Centro de Investigaciones de Latinoamerica, Guatemala City, Guatemala.
Adam KolarzNovartis Pharma AG, Basel, Switzerland.
Peter D'AndreaNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Volkan MangaNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Monish JainNovartis Institutes for BioMedical Research, Cambridge, MA, USA.
Soniya VaidyaNovartis Institutes for BioMedical Research, Cambridge, MA, USA.
Michele ValentinNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Biswajit SenNovartis Healthcare Pvt. Ltd, Hyderabad, India.
Novartis (United States) · USHacettepe University · TRInstitute of Materials and Environmental Chemistry · HUKarl Bremer Hospital · ZANovartis (India) · INNovartis (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIndacaterol acetate (IND), a long-acting β

methodsIn this Phase IIb, multicenter, randomized, double-blind, parallel-group study, pediatric patients (aged ≥ 6 to < 12 years) with persistent asthma were randomized (1:1) to receive either IND 75 µg od or IND 150 µg od via Breezhaler

resultsIn total, 80 patients received IND 75 µg (n = 39) or IND 150 µg (n = 41). The study met its primary endpoint; both doses demonstrated improvements in pre-dose trough FEV

conclusionsOnce-daily IND 75 μg and IND 150 μg via Breezhaler

trial registrationClinicalTrials.gov (NCT02892019; 08-Sep-2016).

Indexed as

AsthmaAcetatesChildDouble-Blind MethodForced Expiratory VolumeHumansIndansQuinolonesAcetatesindacaterolIndansQuinolones

Identifiers

PMID37682405
PMCPMC10514176
OpenAlexW4386530698

What OpenQuestion holds

Textmetadata
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.