Evidence map›Paper›PMID 32967685›Full record

Trial reportRespiratory research2020

Lung function, pharmacokinetics, and tolerability of inhaled indacaterol maleate and acetate in asthma patients.

David Miller, Soniya Vaidya, Juergen Jauernig, Brian Ethell, Kristina Wagner, Rajkumar Radhakrishnan, Hanns-Christian Tillmann

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03257995 (A Randomized, Double-blind, Placebo-controlled, Three-period Cross-over Study to Assess the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 32% 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.

NCT03257995 phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled, Three-period Cross-over Study to Assess the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts (Maleate and Acetate) Delivered Via the Concept1 Inhalation Device in Patients With Asthma

TypeinterventionalSponsorNovartis PharmaceuticalsRan2017 to 2018Enrolled54ConditionsAsthmaArmsIndacaterol maleate, Indacaterol acetate, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  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 5 institutions in 3 countries.

David MillerNortheast Medical Research Associates Inc., North Dartmouth, MA, USA.
Soniya VaidyaAxcella Health, Cambridge, MA, USA.
Juergen JauernigNovartis Pharma AG, Basel, Switzerland.
Brian EthellNovartis Institutes for Biomedical Research, Cambridge, MA, USA.
Kristina WagnerNovartis Institutes for Biomedical Research, Cambridge, MA, USA.
Rajkumar RadhakrishnanNovartis Healthcare Pvt. Ltd., Hyderabad, India.
Hanns-Christian TillmannNovartis Institutes for Biomedical Research, Basel, Switzerland. hanns-christian.tillmann@novartis.com.
Novartis (Switzerland) · CHNovartis (United States) · USAxcella Health (United States) · USMedical Research Associates · USNovartis (India) · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIndacaterol maleate delivered with the Breezhaler® inhalation device is a long-acting β

methodsThis was a randomised, double-blind, three-period crossover study (ClinicalTrials.gov identifier, NCT03257995) in patients with asthma on background ICS therapy. Patients with percent predicted pre-bronchodilator forced expiratory volume per second (FEV

resultsOf the 54 adult patients (median age of 48 years), 51 patients completed the study. Both indacaterol salts demonstrated statistically significant improvements in trough FEV

conclusionsIn patients with asthma, indacaterol maleate and acetate elicited comparable and significant improvements in lung function compared with placebo and achieved comparable systemic exposure. Both indacaterol salts were safe and well tolerated.

trial registrationClinicalTrials.gov NCT03257995 June 06, 2017.

Indexed as

AcetatesAdministration, InhalationAdultAgedAsthmaCross-Over StudiesDouble-Blind MethodDrug CombinationsFemaleHumansIndansLungMaleMiddle AgedNebulizers and VaporizersQuinolonesAcetatesDrug CombinationsindacaterolIndansQuinolonesAsthmaEfficacyLABAPharmacodynamicsPharmacokineticRandomised control trial

Identifiers

PMID32967685
PMCPMC7513528
OpenAlexW3087961076

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.