This trial is active, not recruiting.

Condition long term ventilation
Treatment dornase alfa
Phase phase 2/phase 3
Sponsor University Hospital Tuebingen
Collaborator Joachim Riethmueller, Dr. med.
Start date August 2003
End date July 2006
Trial size 540 participants
Trial identifier NCT00204685, LUFIT


The purpose of this study is to determine whether Inhalation of Recombinant Human Deoxyribonuclease Shortens Ventilation Time in Mechanically Ventilated Adults

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

Time of mechanical ventilation from beginning of the ventilation-therapy up to the end of the ventilation-therapy
time frame:

Secondary Outcomes

reduction of atelectasis / dystelectasis
time frame:
improval of pulmonaryfunction
time frame:
reduction of pneumonia
time frame:
reduction of DNA concentrations in Airway Secretions
time frame:
length of stay at the Intensive Care Unit
time frame:
length of stay at the hospital
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - adult - mechanical ventilation - expected ventilation time 3 days or longer - full therapy is possible - expectet ventilation time not longer than 21 days Exclusion Criteria: - medicinal point of view: patient won´t survive the next 21 days - concomitant pneumococcal disease (like tuberculosis, carcinoma) - endotracheal bleeding - pneumothorax with no relief (e.g. thoracic drainage) - pregnancy - breast feeding - participation in another clinical trail - mechanical ventilation since more than 48 hours - mechanical ventilation on the basis of another reason than operation, trauma or pulmonary decompensation

Additional Information

Official title Beatmungsdauer Und Lungenfunktion Bei Beatmeten Patienten Unter Therapie Mit Dornase Alfa - Randomisierte, Doppel-Blinde, Placebo-Kontrollierte, Multizentrische, Prospektive Klinische Studie
Description Recombinant human deoxyribonuclease I (rhDNase, dornase alpha), administered by inhalation, is currently used as a mucolytic agent in the treatment of cystic fibrosis. This prospective, randomized, placebo-controlled, double-blind clinical study should carry out whether the therapeutic use of rhDNase can be extended to adults who are undergoing long term ventilation at the intensive care. It is hypothesized that mechanically ventilated patients show elevated concentrations of DNA in airway secretions, and that these pathological DNA levels are reduced by rhDNase. The primary clinical goal of the study is to establish wether ventilation times are shortend under inhalation of rhDNAse during the ventilation time. hDNase (verum) is compared with equal amounts of 0.9% saline solution (placebo).
Trial information was received from ClinicalTrials.gov and was last updated in September 2006.
Information provided to ClinicalTrials.gov by University Hospital Tuebingen.