Evidence map›Paper›PMID 27308826›Full record

Trial reportPloS one2016

Mucolytic Effectiveness of Tyloxapol in Chronic Obstructive Pulmonary Disease - A Double-Blind, Randomized Controlled Trial.

Martin Koppitz, Charlotte Eschenburg, Emilia Salzmann, Martin Rosewich, Ralf Schubert, Stefan Zielen

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02515799 (A Double-blind, Placebo Controlled, Randomized Crossover Trial to Characterize the Mucolytic Effectiveness of Tacholiquine® in Chronic Bronchitis), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 28% 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.

NCT02515799 phase4completednot on this map

A Double-blind, Placebo Controlled, Randomized Crossover Trial to Characterize the Mucolytic Effectiveness of Tacholiquine® in Chronic Bronchitis

TypeinterventionalSponsorbene-Arzneimittel GmbHRan2014 to 2015Enrolled27ConditionsBronchitis, Chronic, Pulmonary Disease, Chronic ObstructiveArmsTacholiquine, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Review
  6. The COPD Pipeline XXXIII.Chronic obstructive pulmonary diseases (Miami, Fla.) · 2017
    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

6 authors at 1 institution in 1 country.

Martin KoppitzDepartment for Children and Adolescents, Division for Allergology, Pneumology and Cystic Fibrosis, University Hospital Goethe University, Frankfurt am Main, Germany.
Charlotte EschenburgDepartment for Children and Adolescents, Division for Allergology, Pneumology and Cystic Fibrosis, University Hospital Goethe University, Frankfurt am Main, Germany.
Emilia SalzmannDepartment for Children and Adolescents, Division for Stem Cell Transplantation and Immunology, University Hospital Goethe University, Frankfurt am Main, Germany.
Martin RosewichDepartment for Children and Adolescents, Division for Allergology, Pneumology and Cystic Fibrosis, University Hospital Goethe University, Frankfurt am Main, Germany.
Ralf SchubertDepartment for Children and Adolescents, Division for Allergology, Pneumology and Cystic Fibrosis, University Hospital Goethe University, Frankfurt am Main, Germany.
Stefan ZielenDepartment for Children and Adolescents, Division for Allergology, Pneumology and Cystic Fibrosis, University Hospital Goethe University, Frankfurt am Main, Germany.
Goethe University Frankfurt · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveMucoactive drugs should increase the ability to expectorate sputum and, ideally, have anti-inflammatory properties. The aim of the study was to evaluate the mucolytic activity of Tyloxapol compared to saline (0.9%) in COPD.

designA randomized, placebo-controlled, double-blinded crossover, clinical trial was carried out. Patients were randomly assigned to either inhale 5 ml Tyloxapol 1% or saline 0.9% solution three times daily for 3 weeks and vice versa for another 3 weeks. 28 patients (18 male, 10 female, 47 to 73 years old, median age 63.50) were screened, 21 were treated and 19 patients completed the study per protocol.

resultsA comparison of the two treatment phases showed that the primary endpoint sputum weight was statistically significant higher when patients inhaled Tyloxapol (mean 4.03 g, 95% CI: 2.34-5.73 g at week 3) compared to saline (mean 2.63 g, 95% CI: 1.73-3.53 g at week 3). The p-value at three weeks of treatment was 0.041 between treatment arms. Sputum cells decreased during the Tyloxapol treatment after 3 weeks, indicating that Tyloxapol might have some anti-neutrophilic properties. Lung function parameters (FVC, FEV1, RV, and RV/TLC) remained stable during the study, and no treatment effect was shown. Interestingly, there was a mean increase in all inflammatory cytokines (IL-1β, IL-6, and IL-8) during the saline treatment from day 1 to week 3, whereas during the Tyloxapol treatment, all cytokines decreased. Due to the small sample size and the large individual variation in sputum cytokines, these differences were not significant. However, analyses confirmed that Tyloxapol has significant anti-inflammatory properties in vitro. Despite the high number of inhalations (more than 1000), only 27 adverse events (20 during the Tyloxapol and seven during saline) were recorded. Eleven patients experienced AEs under Tyloxapol and six under saline treatment, which indicates that inhalation of saline or Tyloxapol is a very safe procedure.

conclusionOur study demonstrated that inhalation of Tyloxapol by patients with COPD is safe and superior to saline and has some anti-inflammatory effects.

trial registrationClinicalTrials.gov NCT02515799.

Indexed as

Administration, InhalationAgedDouble-Blind MethodExpectorantsFemaleForced Expiratory VolumeHumansInflammationMaleMiddle AgedPolyethylene GlycolsPulmonary Disease, Chronic ObstructiveSputumTreatment OutcomeExpectorantsPolyethylene Glycolstyloxapol

Identifiers

PMID27308826
PMCPMC4911120
OpenAlexW2443577726

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.