Projects

Research Projects (2015, ongoing)

European Management Platform for children´s interstitial lung diseases (chILD-EU) Kids lung register
In vitro modelling of the surfactant transporter ABCA3 defects DZL 2.0
Molecular genetic diagnosis of rare pediatric lung diseases DZL 2.0
HCQ4Surf-E-Rare Erare, BMBF
ENTeR-chILD-COST EU

 

Clinical trials (2015, ongoing)

2015- RECRUITING

 

 

2015 – ongoing

 

  

2015 – ongoing

 

 

2016 - ongoing

Hydroxychloroquine in pediatric ILD: START randomized controlled in parallel-group, then switch placebo to active drug, and STOP randomized controlled in parallel-group to evaluate the efficacy and safety of hydroxychloroquine (HCQ) EudraCT: 2013-003714-40 NCT02615938

A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis,Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Vertex Study Number: VX14-661-108 VX-661 IND Number: 108,105 EudraCT Number: 2014-004788-18. NCT02392234

A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to       Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects  Aged 12 Years and OlderWith Cystic Fibrosis, Homozygous for the F508del-CFTR   Mutation Vertex Study Number:VX14-661-106, IND Number: 108,105 EudraCT Number: 2014-004837-13, NCT02347657

Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long- term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Vertex Study Number: VX14-661-110, VX-661 IND Number: 108,105, Ivacaftor IND Number: 74,633 EudraCT Number: 2014-004827-29, 4 NCT02565914

 

 

Projects (1999-2015, closed)

Topic Funding
Großgeräteantrag mit AG Klein; Confokales ZEISS-Lasermikroskop DFG
Chronic tachypnea of infancy; pediatric interstitial lung diseases DZL 1.0
Israel Kooperationsprojekt on rare lung diseases Hirmer Stiftung
Cells models of the surfactant transporter ABCA3 DFG-970/8-1
chILD – EU-Projekt: Orphans Unite: chILD better together –? European Management Platform for Childhood Interstitial Lung Diseases. Grant Agreement number 305653 EU
A PHASE 3 EXTENSION STUDY OF ATALUREN (PTC124) IN PATIENTS WITH NONSENSE MUTATION CYSTIC FIBROSIS EudraCT Number 2014-005355-83. NCT02456103 PTC
A Phase 2, Multi-centre Double-Blinded Placebo-Controlled 3 Part Study to evaluate Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of VX661 Monotherapy and VX-661/VX-770 Cotherapy in Subjects with Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation. EudraCT-Nr.: 2011-003821-93. Vertex
A Phase 3, open-label, randomized trial to evaluate the safety and efficacy of MP-376 inhalation solution (AEROQUIN™) versus Tobramycin inhalation solution (TIS) in stable cystic fibrosis patients. EudraCT-Nr.: 2010-019634-26. MPex
An Open-Label, Rollover Study to Evaluate the Long-Term Safety and Efficacy of VX-770 in Subjects with Cystic Fibrosis. EudraCT-Number:2009-012997-1. Dec 2010 – 2013. Vertex
Europäisches Alveolarproteinose-Netzwerk (Eu-PAP-Net) BMBF
A Phase 3, Randomized, Double-Blind, Placebo‑Controlled, Parallel‑Group Study to Evaluate the Efficacy and Safety of VX‑770 in Subjects with Cystic Fibrosis and the G551D Mutation. EudraCT-Number:2008-007416-15. Dec 2009 – Dec 2010. Vertex
A randomized controlled study to investigate the efficacy and safety of 24 weeks of inhaled treatment with glutathione in cystic fibrosis North American CF foundation (NACF)
Deutsches Netzwerk für diffus parenchymatöse Lungenerkrankungen: GOLD.net BMBF
A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 μg and 5 μg) administered once daily via the Respimat® device for 12 weeks in patients with cystic fibrosis. EudraCT-Number: 2008-001156-43. Boehringer Ingelheim
An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab (Xolair) in cystic fibrosis complicated by allergic bronchopulmonary aspergillosis. EudraCT-Number:2007-006648-23. Novartis
Molekulare Auswirkungen von Gendefekten im Surfactantsyntheseapparat von Typ II Pneumozyten bei interstitiellen Lungenerkrankungen (ILD) DFG Gr970/7-3
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis. Astraceneca
IGOR-basic – ex vivo study of the effects of inhaled glutathione Mukoviszidose eV
Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients Mukoviszidose eV
A Randomised, Open-label, Multicenter, Active controlled study of Tobramycin 100 PARI nebulised with eFlow® versus TOBI® nebulised with PARI LC PLUS® in Cystic Fibrosis Patients. Pari GmbH
International multicentre study in cystic fibrosis (TIP003) Chiron
Pharmacokinetics of inhaled tobramycin Pari GmbH
A mass spectrometric search for serum markers of allergic bronchopulmonary aspergillosis (ABPA) in cystic fibrosis Mukoviszidose eV
Genetik der Collektine bei CF Mukoviszidose eV
Molekulare Auswirkungen von Gendefekten im Surfactantsyntheseapparat von Typ II Pneumozyten bei interstitiellen Lungenerkrankungen (ILD) DFG Gr970/7-2
Follow up, lung function Pharmacia
A randomized controlled study to investigate the efficacy and safety of 24 weeks of inhaled treatment with glutathione in cystic fibrosis North American CF foundation (NACF)
BI-Trial 543.45: Weltweite, randomisierte Multizenterstudie, Doppel-blind-Placebo-kontrolliert an Patienten mit Cystischer Fibrose Böhringer Ingelheim
Inhaled a1-Antitrypsin in cystic fibrosis Bayer, Central lab
Multicentre, randomized, two arm trial Prolastin® to investigate the optimal deposition site for inhaled Prolastin® in patients with cystic fibrosis Bayer, Koordinationszentrum
AKITA-Deposition of Prolastin in central and peripheral airways Bayer, Koordinationszentrum
Lungenerkrankungen unklarer Ursachen im Neugeborenen- und Kindesalter – biochemische Grundlagen DFG Gr970/7-1
Oxidative Schädigung bei chronischen respiratorischen Erkrankungen im Kindesalter DAAD Stipendium
Respiratorische Erkrankungen durch gastro-ösophageale Refluxe Projektförderung von Forschung und Lehre durch die LMU München 2002
Folgestudie – Nachbeobachtung der Kohorte von Kindern und Jugendlichen mit Cystischer Fibrose Pharmacia 2003/2004
Partizipation an multizenterischer, randomisierter, doppelblinder, plazebokontrollierter Parallelgruppenstudie zur Bewertung der metabolischen und respiratorischen Wirksamkeit von Somatropin bei Kindern und Jugendlichen mit Cystischer Fibrose Pharmacia 2001/2002
Untersuchung der Surfactant Collectine und der Collectin-kodierenden Gene als potentieller Modifikatoren des Verlaufs der CF-Lungeerkrankung – Deutsch-französisches Gemeinschaftsprojekt Mukoviszidose eV und der Vaincre la Mucoviscidose 2001
Interaktionen von Surfactant Protein A und D mit Aspergillus fumigatus bei Cystischer Fibrose Projektförderung von Forschung und Lehre durch die LMU München 2001
Glutathion-Aerosol bei CF Mukoviszidose eV
GSH-Deposition in der Lunge Cf-Selbsthilfe 2001/2
Chronische Atemtraktinflammation im Säuglings- und Kleinkindalter- nicht-invasive Evaluation der Behandlung mit inhalativen Steroiden GlaxoWellcome 2001
Bestimmung von Chemokin-Rezeptoren bei Atemwegserkrankungen im Kindesalter F.-Baur-Stiftung 2000
Untersuchungen der Surfactantdysfunktion mit dem capillären Surfactometer MMW 2000
Untersuchung allergischer Antikörper gegen rekombinante und natürliche Schimmelpilzallergen wie sie in der Allergie-Diagnostik verwendet werden Sanofi/Biorad
Invasive und nicht-invasive Marker der Atemwegsinflammation Vaillant-Stiftung
Multizenterstudie BEAT, Lavage bei CF Mukoviszidose e.V.
Schlaflabor-Großgeräteantrag, 2 Plätze DFG/Freistaat Bayern
Nicht-invasive Evaluation der Atemwegsinflammation im Kindesalter F.-Baur-Stiftung 1999
Lung surfactant in Cystic Fibrosis Lung Disease Mukoviszidose e.V.
Surfactantaufnahme und Metabolismus (III) DFG (Gr 970/3-3)
Lungensurfactant und Cystische Fibrose W. Sander-Stiftung III
Multizentrische Studie zur Lavage bei Cystischer Fibrose Roche