Evidence map›Paper›PMID 38046981›Full record

ArticleInternational journal of chronic obstructive pulmonary disease2023

The Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide 400 μg Administered by Inhalation as Single and Multiple (Twice Daily) Doses in Healthy Chinese Participants.

Weimin Li, Sami Z Daoud, Roopa Trivedi, Pradeep B Lukka, Eulalia Jimenez, Eduard Molins, Catherine Stewart, Pranob Bharali, Esther Garcia-Gil

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of chronic obstructive pulmonary disease, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03276052 (A Phase I, Open-Label, Single and Multiple Dose), 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
0.6field-weighted citation impact, top 25% 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.

NCT03276052 phase1completednot on this map

A Phase I, Open-Label, Single and Multiple Dose (Twice-Daily), Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide 400 μg Administered by Inhalation in Healthy Chinese Participants

TypeinterventionalSponsorAstraZenecaRan2021 to 2021Enrolled20ConditionsHealthy VolunteersArmsAclidinium Bromide 400 μg
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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 4 institutions in 4 countries.

Weimin LiClinical Trial Center, West China Hospital of Sichuan University, Chengdu, Sichuan Province, People's Republic of China.ORCID 0000-0001-6685-0161
Sami Z DaoudRespiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Roopa TrivediLate Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Durham, NC, USA.
Pradeep B LukkaClinical & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gaithersburg, MD, USA.
Eulalia JimenezClinical & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Barcelona, Spain.
Eduard MolinsClinical & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Barcelona, Spain.
Catherine StewartStatistics, Phastar, Chiswick, London, UK.
Pranob BharaliLate Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Durham, NC, USA.
Esther Garcia-GilRespiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.
AstraZeneca (Spain) · ESAstraZeneca (United States) · USAstraZeneca (India) · INSichuan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To date, aclidinium pharmacokinetic (PK) studies have focused on Caucasian populations, and no data are available for Chinese populations. We aimed to characterize the PK and safety profile of aclidinium and its metabolites (LAS34823 and LAS34850) following single and multiple (twice-daily; BID) dosing in healthy Chinese participants, and to compare PK data between Chinese and Caucasian populations. Materials and methods: In this Phase I, open-label study (NCT03276052), healthy participants from a single site in China received aclidinium bromide 400 µg via a dry powder inhaler. The Day 1 single dose was followed by a washout period of 96 hours. On Days 5 through 8, participants received BID doses. Results: Twenty healthy Chinese participants, aged 18-45 years, were enrolled. Aclidinium absorption was rapid (median time to maximum concentration [t Conclusion: Single and multiple doses of aclidinium were well tolerated in healthy Chinese participants. The safety profile of and exposure to aclidinium was consistent with previous studies conducted in Caucasian populations.

Indexed as

Muscarinic AntagonistsPulmonary Disease, Chronic ObstructiveAdministration, InhalationAdolescentAdultArea Under CurveDose-Response Relationship, DrugEast Asian PeopleHealthy VolunteersHumansMiddle AgedTropanesWhite PeopleYoung Adultaclidinium bromideMuscarinic AntagonistsTropanesaclidinium bromidebronchodilatorChinachronic obstructive pulmonary diseasepharmacokineticssafety

Identifiers

PMID38046981
PMCPMC10691958
OpenAlexW4389032367

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.