Cystic FibrosisFRA-MUKONCT01479166
Bronchial Inflammation of Small Airways in Patients With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
In the planned study, 60 patients with mild cystic fibrosis (CF) with and without the involvement of small airways (small airway disease - SAD) are to be compared with a historical control group matched in age and gender. Read more about this study
- Who is it for?
- Ages 6 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to May 2012
- Phase
- Observational
- 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 6 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study is carried out in CF children and adults (6 to 60 years) and healthy controls (6-60 years). Both patients (40) and healthy subjects (20) are recruited from the Christiane Herzog CF outpatient clinic of Johann Wolfgang Goethe-University, Frankfurt/M, Germany.
Who may be able to join
- informed consent
- confirmed diagnosis of CF (known mutations and/or sweat chloride test > 60mval/l)
- age between 6 and 60 years
- vital capacity > 75%
- Ability to perform lung function tests and inhalation
Who cannot join
- < 6 and > 60 years of age on the day of written informed consent
- Acute illness with systemic or bronchial inflammation
- every chronic condition or infection (eg HIV, tuberculosis, malignancy)
- pregnancy
- known alcohol and/ or drug abuse
- Inability to understand the extent and scope of the study
- Participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Children's Hospital, Johann Wolfgang Goethe-University
Frankfurt am Main, Hesse, 60590
About this study
In the planned study, 60 patients with mild cystic fibrosis (CF) with and without the involvement of small airways (small airway disease - SAD) are to be compared with a historical control group matched in age and gender. During the first study visit subjects are asked to perform a pulmonary function test (spirometry, body plethysmography with helium, determination of "Trapped Air") and exhaled nitric oxide (eNO) and exhaled carbon monoxide (eCO) measurements will be done in exhaled air. In addition, a blood sample is drawn to describe inflammatory status. Sputum is induced as well. During the second study visit, a non-specific bronchial provocation test(methacholine PD20 FEV1) is performed.
The aim of the study is to get a characterization of the bronchial and systemic inflammation (IL-1ß, IL-6, IL-8, IL-17, TNF-α, NFKB, and recognition structures like TLR2 and TLR4) in CF patients with and without the involvement of the small airways, which may point to new treatment strategies.
Read the detailed description
Aim of this study is the characterization of patients with mild cystic fibrosis in terms of lung function, bronchial hyperreactivity and the degree of systemic and bronchial inflammation.
Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction(qRT-PCR) and by cytometric bead assay (CBA). Components of the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant proteins) are genetically determined from sputum or blood respectively. In order to support the analyzed lung function and sputum/ serum biomarker data the investigators will also rely on pre-existing imaging data like chest x-rays or high-resolution computer tomography (HRCT)of the lungs.
Methods and Work Programme:
This study consists of two study visits (V1 and V2)
V1:
Measurement of nitric oxide in exhaled air (eNO) Measurement of carbon monoxide in exhaled air (eCO) Lung function testing with spirometry and body plethysmography Blood test: blood count, CRP, RAST, serum inflammatory mediators, genetic markers of the non-specific pulmonary defense system Induced sputum for inflammatory mediators and microbiological investigations
V2:
Unspecific bronchial provocation test with methacholine (PD20 FEV1 methacholine) Lung function testing with spirometry and body plethysmography
Study population:
CF Children and adults (6 - 60 years of age) and a healthy control group (6-60 years of age). Both patients and healthy subjects are recruited from the Christiane Herzog Cystic fibrosis outpatient clinic.
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, HRCT, Sputum, Blood, Inflammation, adaptive immune system, innate immune system
- Medical subject headings
- Cystic Fibrosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| affected patients with small airway disease (SAD) | 20 patients suffering from mild cystic fibrosis and involvement of small airways | |
| affected patients without small airway disease (SAD) | 20 patients suffering from mild cystic fibrosis without SAD | |
| non-affected patients | 20 matched controls not suffering from cystic fibrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchial Inflammation in sputum of patients with CF
Measuring IL-8 in induced sputum compared to induced sputum of age matched controls
Measured: 24 months
Secondary outcomes (1)
Inflammatory proteins like (Il-1,IL-6, TNF alpha) in induced sputum
Measuring secondary parameters in induced sputum by cytometric bead assay
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Zielen, Johann Wolfgang Goethe University Hospital
- Investigators
- Stefan Zielen, MD, PhD, Principal investigator, Children´s Hospital of Johann Wolfgang Goethe-Univeristy, Frankfurt/Main
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479166
- Sponsor's protocol ID
- 85/11
- Acronym
- FRA-MUKO
- Status last verified
- Oct 2014
- First submitted
- 22 Nov 2011
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Eickmeier O, Huebner M, Herrmann E, Zissler U, Rosewich M, Baer PC, Buhl R, Schmitt-Grohe S, Zielen S, Schubert R. Sputum biomarker profiles in cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD) and association between pulmonary function. Cytokine. 2010 May;50(2):152-7. doi: 10.1016/j.cyto.2010.02.004. Epub 2010 Feb 23.
PubMed 20181491Tiddens HA, Donaldson SH, Rosenfeld M, Pare PD. Cystic fibrosis lung disease starts in the small airways: can we treat it more effectively? Pediatr Pulmonol. 2010 Feb;45(2):107-17. doi: 10.1002/ppul.21154.
PubMed 20082341
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchial Inflammation of Small Airways in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01479166
- Acronym / sponsor ID
- FRA-MUKO / 85/11
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, HRCT, Sputum, Blood, Inflammation, adaptive immune system, innate immune system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 24 Nov 2011 (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.
In the planned study, 60 patients with mild cystic fibrosis (CF) with and without the involvement of small airways (small airway disease - SAD) are to be compared with a historical control group matched in age and gender. During the first study visit subjects are asked to perform a pulmonary function test (spirometry, body plethysmography with helium, determination of "Trapped Air") and exhaled nitric oxide (eNO) and exhaled carbon monoxide (eCO) measurements will be done in exhaled air. In addition, a blood sample is drawn to describe inflammatory status. Sputum is induced as well. During the second study visit, a non-specific bronchial provocation test(methacholine PD20 FEV1) is performed.
The aim of the study is to get a characterization of the bronchial and systemic inflammation (IL-1ß, IL-6, IL-8, IL-17, TNF-α, NFKB, and recognition structures like TLR2 and TLR4) in CF patients with and without the involvement of the small airways, which may point to new treatment strategies.
Detailed description
Aim of this study is the characterization of patients with mild cystic fibrosis in terms of lung function, bronchial hyperreactivity and the degree of systemic and bronchial inflammation.
Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction(qRT-PCR) and by cytometric bead assay (CBA). Components of the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant proteins) are genetically determined from sputum or blood respectively. In order to support the analyzed lung function and sputum/ serum biomarker data the investigators will also rely on pre-existing imaging data like chest x-rays or high-resolution computer tomography (HRCT)of the lungs.
Methods and Work Programme:
This study consists of two study visits (V1 and V2)
V1:
Measurement of nitric oxide in exhaled air (eNO) Measurement of carbon monoxide in exhaled air (eCO) Lung function testing with spirometry and body plethysmography Blood test: blood count, CRP, RAST, serum inflammatory mediators, genetic markers of the non-specific pulmonary defense system Induced sputum for inflammatory mediators and microbiological investigations
V2:
Unspecific bronchial provocation test with methacholine (PD20 FEV1 methacholine) Lung function testing with spirometry and body plethysmography
Study population:
CF Children and adults (6 - 60 years of age) and a healthy control group (6-60 years of age). Both patients and healthy subjects are recruited from the Christiane Herzog Cystic fibrosis outpatient clinic.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| affected patients with small airway disease (SAD) | – | –20 patients suffering from mild cystic fibrosis and involvement of small airways |
| affected patients without small airway disease (SAD) | – | –20 patients suffering from mild cystic fibrosis without SAD |
| non-affected patients | – | –20 matched controls not suffering from cystic fibrosis |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study is carried out in CF children and adults (6 to 60 years) and healthy controls (6-60 years). Both patients (40) and healthy subjects (20) are recruited from the Christiane Herzog CF outpatient clinic of Johann Wolfgang Goethe-University, Frankfurt/M, Germany.
Key inclusion criteria (5 listed)
- informed consent
- confirmed diagnosis of CF (known mutations and/or sweat chloride test > 60mval/l)
- age between 6 and 60 years
- vital capacity > 75%
- Ability to perform lung function tests and inhalation
Key exclusion criteria (7 listed)
- < 6 and > 60 years of age on the day of written informed consent
- Acute illness with systemic or bronchial inflammation
- every chronic condition or infection (eg HIV, tuberculosis, malignancy)
- pregnancy
- known alcohol and/ or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bronchial Inflammation in sputum of patients with CF
Time frame: 24 months
Measuring IL-8 in induced sputum compared to induced sputum of age matched controls
1 secondary outcome
Inflammatory proteins like (Il-1,IL-6, TNF alpha) in induced sputum
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Background: PubMed 20181491Eickmeier O, Huebner M, Herrmann E, Zissler U, Rosewich M, Baer PC, Buhl R, Schmitt-Grohe S, Zielen S, Schubert R. Sputum biomarker profiles in cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD) and association between pulmonary function. Cytokine. 2010 May;50(2):152-7. doi: 10.1016/j.cyto.2010.02.004. Epub 2010 Feb 23.
- Background: PubMed 20082341Tiddens HA, Donaldson SH, Rosenfeld M, Pare PD. Cystic fibrosis lung disease starts in the small airways: can we treat it more effectively? Pediatr Pulmonol. 2010 Feb;45(2):107-17. doi: 10.1002/ppul.21154.
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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.
Stefan Zielen, MD, PhD principal investigator
Children´s Hospital of Johann Wolfgang Goethe-Univeristy, Frankfurt/Main
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Johann Wolfgang Goethe University Hospital 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 29 Oct 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchial Inflammation in sputum of patients with CF (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01479166, which also lists 2 linked publications.
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 2014.