Clinical Trials

The ultimate goal in translational medicine is to test and validate new therapeutic options in humans and to advance appropriate tools for tailored treatment. Therefore, a major aim of the DZL is to promote and enable the progress of early clinical trials, fostering these approaches.

DZL aims to facilitate innovative investigator initiated studies (IITs) in lung diseases. A particular focus of the DZL are innovative Phase IIa IITs. These might be studies in wellcharacterized subgroups of patients, to explore the option of personalized medicine (for example, in oncology, aiming to match patients with molecularly defined alterations of the tumour to specific treatments). These studies are ideally combined with predictive diagnostics approaches.

Furthermore, studies where industry is less interested or which explore new indications of already authorized or off-patent medicinal products, are in the focus of the DZL.

Innovative science can often lead in unexpected directions. In order to be able to respond to new findings in the field and translate those findings as quickly as possible to positive outcomes for patients, a portion of the DZL budget was set aside for innovative clinical trials.


Presently funded clinical trials involving BREATH:

CHANGE-MRI (CTEPH DIAGNOSIS Europe - MRI) Phase III diagnostic trial to demonstrate that functional lung MRI can replace VQ-SPECT in a diagnostic strategy for patients with suspected CTEPH
Coorditating Investigator: Prof. Dr. Jens Vogel-Claussen
Cooperating Partners: BREATH, CPC, TLRC, UGMLC

CHILD Evaluation of the efficacy and safety of hydroxychloroquine (HCQ) in pediatric interstitial lung disease (ILD)
Coordinating Investigator: Prof. Dr. M. Griese
Cooperating Partners: ARCN, BREATH, CPC, UGMLC

EMoLung Monitoring of patients with NSCLC – epigenetic analysis of liquid biopsies and RNA analysis in exhaled breath condensates (EMoLung)
Coordinating Investigators: Prof. Dr. Martin Reck, Prof. Dr. Ole Ammerpohl
Cooperating Partners: ARCN, BREATH, CPC, TLRC, UGML

ERT-BC Early response capturing in the treatment of adenocarcinoma of the lung
Coordinating Investigator: Prof. Dr. C. Heußel
Cooperating Partners: BREATH, CPC, TLCR, UGMLC

GI-Hope GM-CSF Inhalation to improve HOst defense and Pulmonary barrier rEstoration (GI-HOPE); A randomized, double-blind, parallel group, multicenter, phase IIa study
Coordinating Investigator: Prof. Dr. Susanne Herold
Cooperating Partners: BREATH, UGMLC

Lippenbremse Evaluation of non-invasive pursed-lip breathing ventilation (PLBV) in advanced COPD
Coordinating Investigator: PD Dr. K. Geade, Prof. Dr. P. Zabel
Coordinating Partners: ARCN, BREATH, TLRC

MR-COPD II Imaging disease progression in COPD
Coordinating Investigator: B. Jobst
Cooperating Partners: BREATH, TLRC

OrkambiFacts Intestinal current measurements (ICM) to evaluate the activation of mutant CFTR in subjects with cystic fibrosis aged 12 years and older, homozygous for the p.Phe508del-CFTR mutation, treated with lumacaftor/ivacaftor
Coordinating Investigator: B. Tümmler
Coorperating Partners: BREATH, TLRC, UGMLC

RELIEF Exploratory efficacy and safety study of oral Pirfenodone for progressive, non-IPF lung fibrosis
Coordinating Investigator: J. Behr
Cooperating Partners: ARCN, BREATH, CPC, TLRC, UGMLC