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

NCT02591524 | Unknown

• 1 other identifier: LuTx-CF-colonization_1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Lungtransplantation; Paranasal Sinus Diseases

Outcome Measures

Primary Outcomes (1)

• graft colonization after lung Transplantation (lower respiratory tract)

  number of patients with positive microbiological testing of bronchoalveolar lavage

  6 month

Secondary Outcomes (3)

• Symptoms of rhinosinusitic involvement

  12 month

• Upper airway colonization with pathogens

  12 month

• Incidence of chronic lung allograft dysfunction, infections and hospitalizations

  12 month

Study Arms (1)

Cystic fibrosis airway colonization

EXPERIMENTAL

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

Other: Bronchoalveolar and Nasal Lavage

Interventions

Bronchoalveolar and Nasal Lavage 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

Cystic fibrosis airway colonization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• no informed consent

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Department of Respiratory Medicine, Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Cystic Fibrosis; Paranasal Sinus Diseases

Interventions

Nasal Lavage

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Nose Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Central Study Contacts

Jens Gottlieb, Prof.

CONTACT

+49 511 532; gottlieb.jens@mh-hannover.de

Susanne Hoyer

CONTACT

+49 511 532; hoyer.susanne@mh-hannover.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Thomas Fühner

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 29, 2015
• Study Start: November 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

DE (1)