Cystic Fibrosis Lung DiseaseTRACK-CFNCT02270476
Longitudinal Observational Study on the Course of Cystic Fibrosis Lung Disease in Patients Following Newborn Screening
An observational study of Cystic Fibrosis Lung Disease, run by Heidelberg University at 4 sites in Germany.
Trial summary
The purpose of this study is to further characterize early CF lung disease in newborns, infants and toddlers with cystic fibrosis (CF). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis Lung Disease
- How many people
- 200 participants
- Where
- 4 sitesGermany
- Study dates
- Dec 2011to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with CF diagnosed in the first 4 months of life (corrected age of 4 months in preterms) not before January 1st, 2006 build up the early diagnosed (ED) group. Early identification can be achieved by newborn screening, clinical diagnosis (e.g. patients with meconium ileus), due to positive family history or prenatal diagnosis. Patients with CF diagnosed after the first 4 months of life and after January 1st, 2006, are included as a comparison group with clinically diagnosed patients (late diagnosed, LD). Both groups (ED and LD) are investigated after the same investigational plan with all investigations that are part of the annual check-up and additional, study-related monthly telephone interviews on bronchopulmonary symptoms, quarterly assessment of QoL and voluntarily yearly bronchoscopy with broncho-alveolar lavage.
Who may be able to join
- Newly diagnosed patients with Cystic Fibrosis (CF). Diagnosis of CF: at least one of the following three international accepted criteria is fulfilled: i) sweat chloride ≥ 60mEq/L and/or ii) 2 CF-causing mutations in the CFTR gene and/or iii) changes typical for CF in the transepithelial potential difference in nasal or rectal epithelium.
- Age and mode of diagnosis:
- Early diagnosed (ED): Initial diagnosis following CF-NBS or for other reasons in the first 4 months of life (in preterms corrected age of 4 months) after January 1st, 2006. Other reasons could be prenatal diagnostics, meconium ileus or positive family history.
- Late diagnosed (LD): Diagnosed after the fourth month of life due to clinical symptoms; initial diagnosis after January 1st, 2006.
Who cannot join
- All patients are excluded who themselves or whose parents do not want to participate or that withdraw from the study; or those in whom the diagnosis of CF is unsure.
- Further exclusion criteria are:
- Preterms <30th week of gestation
- Longer period of mechanical ventilation in first 3 months of life
- A significant medical disease or condition other than CF likely to interfere with the child's ability to complete the entire protocol
- Previous major surgery except for meconium ileus or atresia of the intestine
Show all 13Show fewer
- Other major organ dysfunction, excluding pancreatic or hepatic dysfunction or another condition due to CF
- Physical findings that would compromise the safety of the subject or the quality of the study data as determined by investigator
- Chronic lung disease other than CF (e.g. bronchopulmonary dysplasia)
- History of adverse reaction to medication for sedation or known claustrophobia
- Criteria, which lead to a displacement of the procedures in sedation until the child has recovered: - Clinically significant upper airway obstruction as determined by investigator (e.g.
- severe laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnoea)
- Severe gastroesophageal reflux, defined as persistent frequent emesis despite anti-reflux therapy
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites, 4 recruiting
- Recruiting
University Hospital Gießen and Marburg GmbH
Giessen, Hesse, 35392
Lutz Nährlich, MD, +49 (0) 641 985-57621, lutz.naehrlich@paediat.med.uni-giessen.de
Lutz Nährlich, MD
- Recruiting
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Christian Dopfer, MD, +49 (0)1761 532 3325, dopfer.christian@mh-hannover.de
Christian Dopfer, MD
- Recruiting
University Children's Hospital Heidelberg, Cystic Fibrosis Centre
Heidelberg, Baden-Wurttemberg, 69120
Marcus A Mall, MD, +49 6221 56 4502, Marcus.Mall@med.uni-heidelberg.de
Mirjam Stahl, MD, +49 6221 56 37049, Mirjam.Stahl@med.uni-heidelberg.de
- Recruiting
University Children's Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Matthias V Kopp, MD, +49 (0) 451 5002550, matthias.kopp@uksh.de
Matthias V Kopp, MD
About this study
The purpose of this study is to further characterize early CF lung disease in newborns, infants and toddlers with cystic fibrosis (CF).
Read the detailed description
Cystic fibrosis (CF) is the most common lethal genetic multisystem disease in Germany. Although life expectancy increased over the last decades, most of the CF patients die in young adulthood due to chronic CF lung disease with respiratory failure. CF lung disease is caused by a disturbed transport of salt and water by airway epithelia and dehydration of airway surfaces as a result of the underlying genetic defect in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gen. Up to now, no causal therapies for the majority of patients with CF are available. Little is known about onset and natural course as well as influencing factors of CF lung disease. Therefore, the first aim of this prospective, multicenter, uncontrolled, non-randomized, explorative longitudinal study is characterization of the onset and early course of CF lung disease. For this reason we will primarily include patients diagnosed by CF newborn screening (CF-NBS) or for any other reason in the first four months of life (early diagnosed, ED). In a second step we will compare data from these patients to those diagnosed clinically later in life (late diagnosed, LD). This will allow us to investigate the effect of early diagnosis and start of therapy. Starting at diagnosis, we will use data from annual routine check-ups (imaging like chest MRI, pulmonary function tests, microbiology from swabs and sputum, laboratory values, anthropometry) as well as data from a facultative, study-related bronchoscopy with lavage (microbiology, inflammation and immunology) for correlation with the course of CF lung disease (generation of hypotheses). Further study-related investigations are monthly telephone interviews on bronchopulmonary symptoms by a study nurse on the basis of a questionnaire and quarterly assessment of health-related quality of life on the basis of a validated questionnaire.
We expect to gain a deeper insight into onset and early course of CF lung disease from the results of this study. So far, there is no trial that investigated the different aspects of CF lung disease (function, morphology, infectiology, inflammation) complementary in a longitudinal setting. We assume that knowledge on the natural history of CF lung disease in the vulnerable phase of early childhood has a great impact on the future development of new therapies (from symptomatic to causal). This shall lead to a further improvement in life expectancy and quality of life of patients with CF.
- Conditions
- Cystic Fibrosis Lung Disease
- Keywords
- Cystic Fibrosis, Infant, Toddler, Children, Newborn screening
- Medical subject headings
- Cystic Fibrosis
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 |
|---|---|---|
| Early diagnosed (ED) | Children diagnosed with CF in the first 4 months of life. | |
| Late diagnosed (LD) | Children diagnosed with CF after the first 4 months of life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion with morphological and/or perfusion changes due to CF lung disease after chest MRI score in both groups
Measured: At age of 1, 2, 3, ...., 10 years of age
Proportion of patients with impairments in pulmonary function tests (e.g. multiple breath washout (MBW)) in both groups
Measured: At age of 1, 2, 3, ...., 10 years of age
Secondary outcomes (12)
Rate of protocol-defined pulmonary exacerbations in both groups (ED vs. LD) that are necessitating an antibiotic therapy orally, intravenously or per inhalation
Measured: At age of 1, 2, 3, ...., 10 years of age
Spontaneous development of infection or spectrum of pathogens, respectively, in throat and nose swabs as well as other airway secretions from routine diagnostics and if applicable bronchoalveolar lavage fluid (BALF)
Measured: At age of 1, 2, 3, ...., 10 years of age
From the patients in whom PsA or other CF pathogens could not be isolated at the beginning of their participation, comparison of the portion of patients with a positive culture during participation in both groups (ED and LD)
Measured: At age of 1, 2, 3, ...., 10 years of age
Time to first detection of a CF pathogen in both groups
Measured: At age of 1, 2, 3, ...., 10 years of age
Time to first pulmonary exacerbation in both groups
Measured: At age of 1, 2, 3, ...., 10 years of age
Portion of patients with increased biochemical inflammatory markers in both groups and magnitude of elevation
Measured: At age of 1, 2, 3, ...., 10 years of age
Frequency of symptoms from monthly telephone interviews in both groups
Measured: At age of 1, 2, 3, ...., 10 years of age
Health-related quality of life in both groups quarterly via Cystic Fibrosis Questionnaire (CFQ)
Measured: At age of 1, 2, 3, ...., 10 years of age
Development of body weight, body height, ideal weight-for-height (IWFH), Body-Mass-Index (BMI), respiratory rate and oxygen saturation at room air in both groups
Measured: At age of 1, 2, 3, ...., 10 years of age
Proportion with morphological changes due to CF lung disease after modified Chrispin-Norman Score for assessment of chest X-ray in both groups
Measured: At age of 1, 2, 3, ...., 10 years of age
Magnitude and severity of alterations typical for CF by assessment with chest MRI and X-ray score in both groups
Measured: At age of 1, 2, 3, ...., 10 years of age
Magnitude of impairment of pulmonary function test in both groups
Measured: At age of 1, 2, 3, ...., 10 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startDec 2011
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis Lung DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Lung Research
- Responsible party
- Principal investigator, Mirjam Stahl, Heidelberg University
- Investigators
- Marcus A Mall, MD, Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270476
- Sponsor's protocol ID
- UKH-TRACK-1
- Acronym
- TRACK-CF
- Status last verified
- Nov 2023
- First submitted
- 16 Oct 2014
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Wielputz MO, Stahl M, Triphan SMF, Wucherpfennig L, Leutz-Schmidt P, Gestewitz S, Steinke E, Graeber SY, Kauczor HU, Eichinger M, Puderbach MU, Alrajab A, Schenk JP, Sommerburg O, Mall MA. Longitudinal Magnetic Resonance Imaging of Changes in Lung Morphology and Perfusion in Children with Cystic Fibrosis from Infancy through Adolescence. Ann Am Thorac Soc. 2025 Jan;22(1):93-103. doi: 10.1513/AnnalsATS.202404-396OC.
PubMed 39255452Steinke E, Sommerburg O, Graeber SY, Joachim C, Labitzke C, Nissen G, Ricklefs I, Rudolf I, Kopp MV, Dittrich AM, Mall MA, Stahl M. TRACK-CF prospective cohort study: Understanding early cystic fibrosis lung disease. Front Med (Lausanne). 2023 Jan 6;9:1034290. doi: 10.3389/fmed.2022.1034290. eCollection 2022.
PubMed 36687447Wucherpfennig L, Wuennemann F, Eichinger M, Schmitt N, Seitz A, Baumann I, Stahl M, Graeber SY, Chung J, Schenk JP, Alrajab A, Kauczor HU, Mall MA, Sommerburg O, Wielputz MO. Longitudinal Magnetic Resonance Imaging Detects Onset and Progression of Chronic Rhinosinusitis from Infancy to School Age in Cystic Fibrosis. Ann Am Thorac Soc. 2023 May;20(5):687-697. doi: 10.1513/AnnalsATS.202209-763OC.
PubMed 36548543Stahl M, Steinke E, Graeber SY, Joachim C, Seitz C, Kauczor HU, Eichinger M, Hammerling S, Sommerburg O, Wielputz MO, Mall MA. Magnetic Resonance Imaging Detects Progression of Lung Disease and Impact of Newborn Screening in Preschool Children with Cystic Fibrosis. Am J Respir Crit Care Med. 2021 Oct 15;204(8):943-953. doi: 10.1164/rccm.202102-0278OC.
PubMed 34283704Stahl M, Wielputz MO, Graeber SY, Joachim C, Sommerburg O, Kauczor HU, Puderbach M, Eichinger M, Mall MA. Comparison of Lung Clearance Index and Magnetic Resonance Imaging for Assessment of Lung Disease in Children with Cystic Fibrosis. Am J Respir Crit Care Med. 2017 Feb 1;195(3):349-359. doi: 10.1164/rccm.201604-0893OC.
PubMed 27575911
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observational Study on the Course of Cystic Fibrosis Lung Disease in Patients Following Newborn Screening
- ClinicalTrials.gov ID
- NCT02270476
- Acronym / sponsor ID
- TRACK-CF / UKH-TRACK-1
- Conditions
- Cystic Fibrosis Lung Disease
- Keywords
- Cystic Fibrosis, Infant, Toddler, Children, Newborn screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- German Center for Lung Research
- Study start
- Dec 2011
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 21 Oct 2014 (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.
The purpose of this study is to further characterize early CF lung disease in newborns, infants and toddlers with cystic fibrosis (CF).
Detailed description
Cystic fibrosis (CF) is the most common lethal genetic multisystem disease in Germany. Although life expectancy increased over the last decades, most of the CF patients die in young adulthood due to chronic CF lung disease with respiratory failure. CF lung disease is caused by a disturbed transport of salt and water by airway epithelia and dehydration of airway surfaces as a result of the underlying genetic defect in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gen. Up to now, no causal therapies for the majority of patients with CF are available. Little is known about onset and natural course as well as influencing factors of CF lung disease. Therefore, the first aim of this prospective, multicenter, uncontrolled, non-randomized, explorative longitudinal study is characterization of the onset and early course of CF lung disease. For this reason we will primarily include patients diagnosed by CF newborn screening (CF-NBS) or for any other reason in the first four months of life (early diagnosed, ED). In a second step we will compare data from these patients to those diagnosed clinically later in life (late diagnosed, LD). This will allow us to investigate the effect of early diagnosis and start of therapy. Starting at diagnosis, we will use data from annual routine check-ups (imaging like chest MRI, pulmonary function tests, microbiology from swabs and sputum, laboratory values, anthropometry) as well as data from a facultative, study-related bronchoscopy with lavage (microbiology, inflammation and immunology) for correlation with the course of CF lung disease (generation of hypotheses). Further study-related investigations are monthly telephone interviews on bronchopulmonary symptoms by a study nurse on the basis of a questionnaire and quarterly assessment of health-related quality of life on the basis of a validated questionnaire.
We expect to gain a deeper insight into onset and early course of CF lung disease from the results of this study. So far, there is no trial that investigated the different aspects of CF lung disease (function, morphology, infectiology, inflammation) complementary in a longitudinal setting. We assume that knowledge on the natural history of CF lung disease in the vulnerable phase of early childhood has a great impact on the future development of new therapies (from symptomatic to causal). This shall lead to a further improvement in life expectancy and quality of life of patients with CF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early diagnosed (ED) | – | –Children diagnosed with CF in the first 4 months of life. |
| Late diagnosed (LD) | – | –Children diagnosed with CF after the first 4 months of life. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with CF diagnosed in the first 4 months of life (corrected age of 4 months in preterms) not before January 1st, 2006 build up the early diagnosed (ED) group. Early identification can be achieved by newborn screening, clinical diagnosis (e.g. patients with meconium ileus), due to positive family history or prenatal diagnosis. Patients with CF diagnosed after the first 4 months of life and after January 1st, 2006, are included as a comparison group with clinically diagnosed patients (late diagnosed, LD). Both groups (ED and LD) are investigated after the same investigational plan with all investigations that are part of the annual check-up and additional, study-related monthly telephone interviews on bronchopulmonary symptoms, quarterly assessment of QoL and voluntarily yearly bronchoscopy with broncho-alveolar lavage.
Key inclusion criteria (4 listed)
- Newly diagnosed patients with Cystic Fibrosis (CF). Diagnosis of CF: at least one of the following three international accepted criteria is fulfilled: i) sweat chloride ≥ 60mEq/L and/or ii) 2 CF-causing mutations in the CFTR gene and/or iii) changes typical for CF in the transepithelial potential difference in nasal or rectal epithelium.
- Age and mode of diagnosis:
Key exclusion criteria (13 listed)
- All patients are excluded who themselves or whose parents do not want to participate or that withdraw from the study; or those in whom the diagnosis of CF is unsure.
- Preterms <30th week of gestation
- Longer period of mechanical ventilation in first 3 months of life
- A significant medical disease or condition other than CF likely to interfere with the child's ability to complete the entire protocol
- Previous major surgery except for meconium ileus or atresia of the intestine
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
Proportion with morphological and/or perfusion changes due to CF lung disease after chest MRI score in both groups
Time frame: At age of 1, 2, 3, ...., 10 years of age
Proportion of patients with impairments in pulmonary function tests (e.g. multiple breath washout (MBW)) in both groups
Time frame: At age of 1, 2, 3, ...., 10 years of age
12 secondary outcomes
Rate of protocol-defined pulmonary exacerbations in both groups (ED vs. LD) that are necessitating an antibiotic therapy orally, intravenously or per inhalation
Time frame: At age of 1, 2, 3, ...., 10 years of age
Spontaneous development of infection or spectrum of pathogens, respectively, in throat and nose swabs as well as other airway secretions from routine diagnostics and if applicable bronchoalveolar lavage fluid (BALF)
Time frame: At age of 1, 2, 3, ...., 10 years of age
From the patients in whom PsA or other CF pathogens could not be isolated at the beginning of their participation, comparison of the portion of patients with a positive culture during participation in both groups (ED and LD)
Time frame: At age of 1, 2, 3, ...., 10 years of age
Time to first detection of a CF pathogen in both groups
Time frame: At age of 1, 2, 3, ...., 10 years of age
Time to first pulmonary exacerbation in both groups
Time frame: At age of 1, 2, 3, ...., 10 years of age
Portion of patients with increased biochemical inflammatory markers in both groups and magnitude of elevation
Time frame: At age of 1, 2, 3, ...., 10 years of age
Frequency of symptoms from monthly telephone interviews in both groups
Time frame: At age of 1, 2, 3, ...., 10 years of age
Health-related quality of life in both groups quarterly via Cystic Fibrosis Questionnaire (CFQ)
Time frame: At age of 1, 2, 3, ...., 10 years of age
Development of body weight, body height, ideal weight-for-height (IWFH), Body-Mass-Index (BMI), respiratory rate and oxygen saturation at room air in both groups
Time frame: At age of 1, 2, 3, ...., 10 years of age
Proportion with morphological changes due to CF lung disease after modified Chrispin-Norman Score for assessment of chest X-ray in both groups
Time frame: At age of 1, 2, 3, ...., 10 years of age
Magnitude and severity of alterations typical for CF by assessment with chest MRI and X-ray score in both groups
Time frame: At age of 1, 2, 3, ...., 10 years of age
Magnitude of impairment of pulmonary function test in both groups
Time frame: At age of 1, 2, 3, ...., 10 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 39255452Wielputz MO, Stahl M, Triphan SMF, Wucherpfennig L, Leutz-Schmidt P, Gestewitz S, Steinke E, Graeber SY, Kauczor HU, Eichinger M, Puderbach MU, Alrajab A, Schenk JP, Sommerburg O, Mall MA. Longitudinal Magnetic Resonance Imaging of Changes in Lung Morphology and Perfusion in Children with Cystic Fibrosis from Infancy through Adolescence. Ann Am Thorac Soc. 2025 Jan;22(1):93-103. doi: 10.1513/AnnalsATS.202404-396OC.
- Derived from this study: PubMed 36687447Steinke E, Sommerburg O, Graeber SY, Joachim C, Labitzke C, Nissen G, Ricklefs I, Rudolf I, Kopp MV, Dittrich AM, Mall MA, Stahl M. TRACK-CF prospective cohort study: Understanding early cystic fibrosis lung disease. Front Med (Lausanne). 2023 Jan 6;9:1034290. doi: 10.3389/fmed.2022.1034290. eCollection 2022.
- Derived from this study: PubMed 36548543Wucherpfennig L, Wuennemann F, Eichinger M, Schmitt N, Seitz A, Baumann I, Stahl M, Graeber SY, Chung J, Schenk JP, Alrajab A, Kauczor HU, Mall MA, Sommerburg O, Wielputz MO. Longitudinal Magnetic Resonance Imaging Detects Onset and Progression of Chronic Rhinosinusitis from Infancy to School Age in Cystic Fibrosis. Ann Am Thorac Soc. 2023 May;20(5):687-697. doi: 10.1513/AnnalsATS.202209-763OC.
- Derived from this study: PubMed 34283704Stahl M, Steinke E, Graeber SY, Joachim C, Seitz C, Kauczor HU, Eichinger M, Hammerling S, Sommerburg O, Wielputz MO, Mall MA. Magnetic Resonance Imaging Detects Progression of Lung Disease and Impact of Newborn Screening in Preschool Children with Cystic Fibrosis. Am J Respir Crit Care Med. 2021 Oct 15;204(8):943-953. doi: 10.1164/rccm.202102-0278OC.
- Derived from this study: PubMed 27575911Stahl M, Wielputz MO, Graeber SY, Joachim C, Sommerburg O, Kauczor HU, Puderbach M, Eichinger M, Mall MA. Comparison of Lung Clearance Index and Magnetic Resonance Imaging for Assessment of Lung Disease in Children with Cystic Fibrosis. Am J Respir Crit Care Med. 2017 Feb 1;195(3):349-359. doi: 10.1164/rccm.201604-0893OC.
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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.
Marcus A Mall, MD principal investigator
University Hospital Heidelberg
4 sites 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 Lung Disease, run by Heidelberg University at 4 sites 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 13 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: looking for participants now, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcus A Mall, MD (+49 6221 56 4502, Marcus.Mall@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion with morphological and/or perfusion changes due to CF lung disease after chest MRI score in both groups (time frame: At age of 1, 2, 3, ...., 10 years of age). The study lists 2 primary outcomes in all. 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 NCT02270476, which also lists 5 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 Nov 2023.