Cystic FibrosisNCT02591524
Upper and Lower Airway Colonization in Cystic Fibrosis Patients After Lung Transplantation
A study testing Bronchoalveolar and Nasal Lavage in people with Cystic Fibrosis and Lungtransplantation, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Lungtransplantation, Paranasal Sinus Diseases
- What is being tested?
- Bronchoalveolar and Nasal Lavage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Respiratory Medicine, Medizinische Hochschule Hannover
Hanover, 30625
About this study
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.
Read the 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
- Being tested
- Bronchoalveolar and Nasal Lavage
- Medical subject headings
- Cystic Fibrosis, Paranasal Sinus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoalveolar and Nasal LavageOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Bronchoalveolar and Nasal Lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
graft colonization after lung Transplantation (lower respiratory tract)
number of patients with positive microbiological testing of bronchoalveolar lavage
Measured: 6 month
Secondary outcomes (3)
Symptoms of rhinosinusitic involvement
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
Measured: 12 month
Upper airway colonization with pathogens
number of patients with positive microbiological testing of nasal lavage
Measured: 12 month
Incidence of chronic lung allograft dysfunction, infections and hospitalizations
number of patients with new chronic lung allograft dysfunction, infections and hospitalizations respectivley
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Fuehner, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591524
- Sponsor's protocol ID
- LuTx-CF-colonization_1
- Status last verified
- Oct 2015
- First submitted
- 27 Oct 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper and Lower Airway Colonization in Cystic Fibrosis Patients After Lung Transplantation
- ClinicalTrials.gov ID
- NCT02591524
- Acronym / sponsor ID
- LuTx-CF-colonization_1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis airway colonization | Experimental | Other: Bronchoalveolar and Nasal LavageFlexible bronchoscopy via the nasal route on the date of baseline visit, nasal lavage at baseline and after 6 month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoalveolar and Nasal LavageA 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 | Other | Cystic fibrosis airway colonization |
Primary outcome
graft colonization after lung Transplantation (lower respiratory tract)
Time frame: 6 month
number of patients with positive microbiological testing of bronchoalveolar lavage
3 secondary outcomes
Symptoms of rhinosinusitic involvement
Time frame: 12 month
Upper airway colonization with pathogens
Time frame: 12 month
Incidence of chronic lung allograft dysfunction, infections and hospitalizations
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoalveolar and Nasal Lavage in people with Cystic Fibrosis and Lungtransplantation, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Gottlieb, Prof. (+49 511 532 ext. 4601, gottlieb.jens@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
graft colonization after lung Transplantation (lower respiratory tract) (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015; AzTrials last refreshed its copy on 8 Nov 2026.