Evidence map›Paper›PMID 24596456›Full record

Trial reportDrug design, development and therapy2014

Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double-blind, placebo-controlled pilot study.

Jochen G Mainz, Katja Schädlich, Claudia Schien, Ruth Michl, Petra Schelhorn-Neise, Assen Koitschev, Christiane Koitschev, Peter M Keller, Joachim Riethmüller, Baerbel Wiedemann and 1 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drug design, development and therapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 31 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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.

NCT00774072 phase2completednot on this map

Nasal Inhalation of Tobramycin by the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization in the Upper Airways

TypeinterventionalSponsorUniversity of JenaRan2008 to 2010Enrolled9ConditionsCystic Fibrosis, Pseudomonas AeruginosaArmsTobramycin (Gernebcin®)
NCT01086839 nacompletednot on this map

Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis. A Multicenter, Randomized, Double-blind, Placebo-controlled, Prospective Clinical Trial

TypeinterventionalSponsorUniversity of JenaRan2010 to 2013Enrolled69ConditionsCystic Fibrosis, RhinosinusitisArmssodium chloride 6%, sodium chloride 0,9%
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2022
    Pooled it
  5. Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis.The Cochrane database of systematic reviews · 2018
    Pooled it
  6. Pooled it
  7. Article
  8. Review
  9. Review
  10. Review
  11. Is there a role for antibiotics in the treatment of chronic rhinosinusitis?The Journal of allergy and clinical immunology · 2022
    Review
  12. Chronic rhinosinusitis in cystic fibrosis: a review of therapeutic options.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2022
    Review
  13. Review
  14. [Management of Primary Ciliary Dyskinesia].Pneumologie (Stuttgart, Germany) · 2020
    Review
  15. Review
  16. Pseudomonas aeruginosa colonization in the upper and lower airways of a child with cystic fibrosis: a father's meticulous approach to successful eradication.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2019
    Article
  17. Review
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Jochen G MainzCystic Fibrosis Centre, Department of Pediatrics, Jena University Hospital, Jena, Germany.
Katja SchädlichCystic Fibrosis Centre, Department of Pediatrics, Jena University Hospital, Jena, Germany.
Claudia SchienCystic Fibrosis Centre, Department of Pediatrics, Jena University Hospital, Jena, Germany.
Ruth MichlCystic Fibrosis Centre, Department of Pediatrics, Jena University Hospital, Jena, Germany.
Petra Schelhorn-NeiseOtorhinolaryngology Department, Jena University Hospital, Jena, Germany.
Assen KoitschevOtorhinolaryngology Department, Klinikum Stuttgart, Germany.
Christiane KoitschevOtorhinolaryngology Department, University Hospital, Tübingen, Germany.
Peter M KellerMicrobiology, Jena University Hospital, Jena, Germany.
Joachim RiethmüllerUniversity Hospital, Pediatric CF-Centre, Tübingen, Germany.
Baerbel WiedemannTechnical University, Biometrics, Dresden, Germany.
James F BeckCystic Fibrosis Centre, Department of Pediatrics, Jena University Hospital, Jena, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleIn cystic fibrosis (CF), the paranasal sinuses are sites of first and persistent colonization by pathogens such as Pseudomonas aeruginosa. Pathogens subsequently descend to the lower airways, with P. aeruginosa remaining the primary cause of premature death in patients with the inherited disease. Unlike conventional aerosols, vibrating aerosols applied with the PARI Sinus™ nebulizer deposit drugs into the paranasal sinuses. This trial assessed the effects of vibrating sinonasal inhalation of the antibiotic tobramycin in CF patients positive for P. aeruginosa in nasal lavage.

objectivesTo evaluate the effects of sinonasal inhalation of tobramycin on P. aeruginosa quantification in nasal lavage; and on patient quality of life, measured with the Sino-Nasal Outcome Test (SNOT-20), and otologic and renal safety and tolerability.

methodsPatients were randomized to inhalation of tobramycin (80 mg/2 mL) or placebo (2 mL isotonic saline) once daily (4 minutes/nostril) with the PARI Sinus™ nebulizer over 28 days, with all patients eligible for a subsequent course of open-label inhalation of tobramycin for 28 days. Nasal lavage was obtained before starting and 2 days after the end of each treatment period by rinsing each nostril with 10 mL of isotonic saline.

resultsNine patients participated, six initially receiving tobramycin and three placebo. Sinonasal inhalation was well tolerated, with serum tobramycin <0.5 mg/L and stable creatinine. P. aeruginosa quantity decreased in four of six (67%) patients given tobramycin, compared with zero of three given placebo (non-significant). SNOT-20 scores were significantly lower in the tobramycin than in the placebo group (P=0.033).

conclusionSinonasal inhalation of vibrating antibiotic aerosols appears promising for reducing pathogen colonization of paranasal sinuses and for control of symptoms in patients with CF.

Indexed as

Administration, InhalationAdolescentAdultAerosolsAnti-Bacterial AgentsChildCystic FibrosisDouble-Blind MethodFemaleHumansMaleNasal MucosaPilot ProjectsPseudomonas aeruginosaTobramycinAerosolsAnti-Bacterial AgentsTobramycincystic fibrosisnasal lavagePARI SinusPseudomonas aeruginosasinonasalSNOT-20upper airways

Identifiers

PMID24596456
PMCPMC3930477

What OpenQuestion holds

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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.