Clinical Trial: Upper and Lower Airway Colonization in Cystic Fibrosis Patients After Lung Transplantation

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Upper and Lower Airway Colonization in Cystic Fibrosis Patients After Lung Transplantation

Brief Summary: A hot topic in lung transplantation is the treatment of persisting sinus disease/colonization in CF patients to prevent descending graft colonization and chronic allograft dysfunction. From 2012, the Hannover transplantation group has been using a conservative approach with topical nasal inhalation. It is now necessary to analyse the impact of the new approach on graft colonization, incidence of BOS, symptoms, QoL etc in comparison to a historical cohort. It is also important to establish which is the best among the different inhaled antibiotic regimens currently available.

Detailed Summary:

These patients will undergo frequent individual centre based follow up care. At each follow up visit, patients will:

  • receive comprehensive clinical examination, history of intercurrent infections and sinus surgery
  • receive quantitative assessment, consisting in spirometry (performed according to ATS/ERS guidelines), arterial blood gas analysis, measurement of immunosuppressive drug levels and chest radiographs
  • receive questionnaires (quality of life (SNOT-20 GAV), side effects of sinus inhalation, symptom scores)
  • be asked to collect a sample of nasal lavage; a sample of BAL (obtained from routinely performed bronchoscopy) will also be collected. These specimens will be analysed for microbiological work up and evaluation of inflammatory markers.

The principle of vibrating inhalation is implemented in novel nebulizers, with which sinonasal inhalation is performed by aerolized medication into one nostril, while the contralateral nostril is occluded and the soft palate elevated as recommended for nasal lavage. The medication is administered into both nostrils for 4-6 min each side during phases of arrest of breathing. Choice of antibiotics depends on resistance testing from microbiological results. Patients will be divided into different groups, on the basis of the inhaled antibiotic regimen being chosen: colistin vs. tobramycin. An alternate therapy with hypertonic saline may be applied to improve sinus clearance. All regimens will be administered with the same machine, i.e. PARI Sinus ™ nebulizer, which, unlike conventional aerosols, allows the deposition of drugs directly into the paranasal sinuses.

The aims of this study are: Sponsor: Hannover Medical School

Current Primary Outcome: graft colonization after lung Transplantation (lower respiratory tract) [ Time Frame: 6 month ]

number of patients with positive microbiological testing of bronchoalveolar lavage


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Symptoms of rhinosinusitic involvement [ Time Frame: 12 month ]

    symptoms will be assessed with a specific questionnaire (SNOT22_GAV modified)

    • Upper airway colonization with pathogens
    • Incidence of chronic lung allograft dysfunction, infections and hospitalizations
  • Upper airway colonization with pathogens [ Time Frame: 12 month ]
    number of patients with positive microbiological testing of nasal lavage
  • Incidence of chronic lung allograft dysfunction, infections and hospitalizations [ Time Frame: 12 month ]
    number of patients with new chronic lung allograft dysfunction, infections and hospitalizations respectivley


Original Secondary Outcome: Same as current

Information By: Hannover Medical School

Dates:
Date Received: October 27, 2015
Date Started: November 2015
Date Completion: April 2016
Last Updated: October 28, 2015
Last Verified: October 2015