Evidence map›Paper›PMID 26098994›Full record

ArticleJournal of aerosol medicine and pulmonary drug delivery2016

In Vitro Determination of Respimat

Deborah Bickmann, Wolfgang Kamin, Ashish Sharma, Herbert Wachtel, Petra Moroni-Zentgraf, Stefan Zielen

Open access · hybridAbstract read
In one paragraph

Article in Journal of aerosol medicine and pulmonary drug delivery, 2016. 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
1.2field-weighted citation impact, top 19% 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, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. The evolving role of tiotropium in asthma.Journal of asthma and allergy · 2017
    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

6 authors at 3 institutions in 1 country.

Deborah Bickmann1 Pharmaceutical Physics Laboratory, Boehringer Ingelheim Pharma GmbH and Co. KG , Ingelheim, Germany .
Wolfgang Kamin2 Children's Hospital , Evangelisches Krankenhaus Hamm, Germany .
Ashish Sharma3 Clinical Pharmacokinetics, Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH and Co. KG, Ingelheim, Germany .
Herbert Wachtel1 Pharmaceutical Physics Laboratory, Boehringer Ingelheim Pharma GmbH and Co. KG , Ingelheim, Germany .
Petra Moroni-Zentgraf1 Pharmaceutical Physics Laboratory, Boehringer Ingelheim Pharma GmbH and Co. KG , Ingelheim, Germany .
Stefan Zielen4 Children's Hospital, Allergology, Pneumology and Cystic Fibrosis, Goethe-University , Frankfurt am Main, Germany .
Boehringer Ingelheim (Germany) · DEEvangelisches Krankenhaus Hamm · DEGoethe University Frankfurt · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAerosol therapy in young children can be difficult. A realistic model based on handling studies and in vitro investigations can complement clinical deposition studies and be used to enable dose-to-the-lung (DTL) predictions.

methodsPredictions on dose delivery to the lung were based on (1) representative inhalation flow profiles from children enrolled in a Respimat

resultsRepresentative inhalation flow profiles for each age group were obtained from 56 children who successfully inhaled a volume >0.15 L from the Respimat with VHC. Average dimensions of the mouth-throat region for 38 children aged 1-<2 years, 2-<3 years, 3-<4 years, and 4-<5 years were determined from NMR/CT scans. The DTL from the Respimat plus VHC were determined by in vitro measurement and were 5.1±1.1%, 15.6%±1.4%, 17.9%±1.5%, and 37.1%±1.8% of the delivered dose for child models 0-<2 years, 2-<3 years, 3-<4 years, and 4-<5 years, respectively. This provides a possible explanation for the age dependence of clinical PK data obtained from the phase 3 tiotropium trial. Calculated in vitro DTL per body mass (μg/kg [±SD]) were 0.031±0.014, 0.066±0.031, 0.058±0.024, and 0.059±0.029, respectively, compared to 0.046 in adults. Therefore, efficacy of the treatment was not negatively impacted in spite of the seemingly low percentages of the DTL.

conclusionsWe conclude that the combination of real-life inhalation profiles with respective mouth-throat models and in vitro determination of delivered DTL is a good predictor of the drug delivery to children via the Respimat with VHC. The data provided can be used to support data from appropriate clinical trials.

Indexed as

childrenfine particle-fractioninhalation breathing patterninspiratory flowlung depositionRespimat Soft Mist™ Inhaler

Identifiers

PMID26098994
PMCPMC4739345
OpenAlexW2100263089

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.