Evidence map›Paper›PMID 19666395›Full record

Trial reportEuropean journal of medical research2009

A phase II study on safety and efficacy of high-dose N-acetylcysteine in patients with cystic fibrosis.

N Dauletbaev, P Fischer, B Aulbach, J Gross, W Kusche, U Thyroff-Friesinger, T O F Wagner, J Bargon

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in European journal of medical research, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 8% 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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. Advances in the Use ofAntioxidants (Basel, Switzerland) · 2023
    Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Antioxidant supplementation for lung disease in cystic fibrosis.The Cochrane database of systematic reviews · 2019
    Review
  13. Review
  14. Review
  15. Redox balance in cystic fibrosis.The international journal of biochemistry & cell biology · 2014
    Review
  16. Review
  17. Article
  18. Article
  19. Article
  20. Mucoactive drugs.European respiratory review : an official journal of the European Respiratory Society · 2010
    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

8 authors at 4 institutions in 1 country.

N DauletbaevUniversity Hospital, Frankfurt/Main, Germany.
P Fischer
B Aulbach
J Gross
W Kusche
U Thyroff-Friesinger
T O F Wagner
J Bargon
Goethe University Frankfurt · DEHexal (Germany) · DEUniversity Hospital Frankfurt · DEClinical Research Services · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe conducted a single-centre, randomised, double-blinded, placebo-controlled phase II clinical study to test safety and efficacy of a 12-week therapy with low-dose (700 mg/daily) or high-dose (2800 mg/daily) of NAC.

methodsTwenty-one patients (DeltaF508 homo/heterozygous, FEV1>40% pred.) were included in the study. After a 3-weeks placebo run-in phase, 11 patients received low-dose NAC, and 10 patients received high-dose NAC. Outcomes included safety and clinical parameters, inflammatory (total leukocyte numbers, cell differentials, TNF-alpha, IL-8) measures in induced sputum, and concentrations of extracellular glutathione in induced sputum and blood.

resultsHigh-dose NAC was a well-tolerated and safe medication. High-dose NAC did not alter clinical or inflammatory parameters. However, extracellular glutathione in induced sputum tended to increase on high-dose NAC.

conclusionsHigh-dose NAC is a well-tolerated and safe medication for a prolonged therapy of patients with CF with a potential to increase extracellular glutathione in CF airways.

Indexed as

AcetylcysteineAdultCystic FibrosisDose-Response Relationship, DrugDouble-Blind MethodFemaleForced Expiratory VolumeFree Radical ScavengersGlutathioneHumansInterleukin-8MaleSputumTumor Necrosis Factor-alphaYoung AdultAcetylcysteineFree Radical ScavengersGlutathioneInterleukin-8Tumor Necrosis Factor-alpha

Identifiers

PMID19666395
PMCPMC3352166
OpenAlexW1536412649

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.