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

NCT ID: NCT02591524

Last Updated: 2015-10-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-04-30

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 Description

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:

• to assess sinus - and pulmonary colonization in cystic fibrosis (CF) lung transplant (LuTx) recipients (frequency of pathogen colonization; load; bacterial species)
• to study association with clinical events (e.g. infections and development of bronchiolitis obliterans syndrome (BOS))
• to develop an optimal inhaled regimen (continuous inhalation/on-off regimen; single or combined antibiotics).
• to compare cohorts receiving sinus surgery in a historical control to a cohort receiving our current conservative strategy (since 2012) of sinonasal vibrating inhalation of antibiotics, in terms of graft colonization, quality of life, overall survival, incidence of chronic lung allograft dysfunction
• to compare inflammatory mediators in upper and lower airway lavages in regard to pathogen colonization, lung function and development of BOS

Conditions

Cystic Fibrosis; Lungtransplantation; Paranasal Sinus Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cystic fibrosis airway colonization

Flexible bronchoscopy via the nasal route on the date of baseline visit, nasal lavage at baseline and after 6 month

Group Type: EXPERIMENTAL

Bronchoalveolar and Nasal Lavage

Intervention Type: OTHER

A previously scheduled flexible bronchoscopy via the nasal route on the date of baseline visit combined with a nasal lavage and another nasal lavage after 6 month

Interventions

Bronchoalveolar and Nasal Lavage

A previously scheduled flexible bronchoscopy via the nasal route on the date of baseline visit combined with a nasal lavage and another nasal lavage after 6 month

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• adult (age > 18 yrs)
• cystic fibrosis
• referral for lung transplantation or follow-up after lung transplantation receiving surgical treatment of sinus disease (sinus surgery) or onservative strategy of sinonasal inhalation of antibiotics
• for patients after lung transplantation: needing a previously scheduled flexible bronchoscopy via the nasal route on the date of baseline visit

Exclusion Criteria

• no informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Thomas Fuehner

PD Dr. med. Thomas Fühner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Respiratory Medicine, Medizinische Hochschule Hannover

Hanover, , Germany

Countries

Germany

Central Contacts

Jens Gottlieb, Prof.

Role: CONTACT

gottlieb.jens@mh-hannover.de

+49 511 532 ext. 4601

Susanne Hoyer

Role: CONTACT

hoyer.susanne@mh-hannover.de

+49 511 532 ext. 4601

Other Identifiers

LuTx-CF-colonization_1

Identifier Type: -

Identifier Source: org_study_id