AzTrials
AzTrials

Long Term VentilationPhase 2/3NCT00204685

Time of Ventilation and Lung Function of Ventilated Patients Under Therapy With Dornase Alfa

A Phase 2/3 study testing dornase alfa in people with Long Term Ventilation, run by University Hospital Tuebingen at 25 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Long Term Ventilation
What is being tested?
dornase alfa
How many people
540 participants
Where
25 sitesGermany
Study dates
Aug 2003to Jul 2006
Phase
Phase 2/3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult
  • mechanical ventilation
  • expected ventilation time 3 days or longer
  • full therapy is possible
  • expectet ventilation time not longer than 21 days

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Germany25 sites

  • Charité, Universitätsmedizin Berlin, Campus Mitte, Innere Intensivstation

    Berlin, 10117

  • Universität Charité, Campus Mitte, Anästhesie, Intensivstation

    Berlin, 10117

  • Vivantes Klinikum Spandau, Klinik für Anästhesie

    Berlin, 13585

  • Klinikum Chemnitz gGmbH, Innere Medizin

    Chemnitz, 09113

  • Universitätsklinikum Erlangen Medizinische Klinik, Intensivstation I

    Erlangen, 91054

  • Universitätsklinikum, Innere Medizin, Intensivstation

    Frankfurt, 60590

  • Universitätsklinikum Hamburg-Eppendorf, Medizinische Intensivstation

    Hamburg, 20246

  • Medizinische Hochschule Hannover, Anästhesiologie

    Hanover, 30625

  • Anästhesiolog. Klinik der Ruprecht-Karls-Universität

    Heidelberg, 69120

  • Universitätsklinikum des Saarlandes, Innere Medizin III, Internistische Intensivstation

    Homburg / Saar, 66421

  • Klinik für Anästhesiologie u. IntensivtherapieUniversität Leipzig

    Leipzig, 04103

  • Universitätsklinik Lübeck, Medizinische Klinik 1

    Lübeck, 23538

  • Department of internal Medicine

    Lüdenscheid, 58505

  • Universität Magdeburg, Innere Medizin,

    Magdeburg, 39120

  • Gutenberg-Universität, Anästhesie-Intensivstation

    Mainz, 55131

  • Johannes Gutenberg-Universität Mainz, II. Medizinische Klinik, Intensivstation

    Mainz, 55131

  • Johannes-Gutenberg-Universität, Neurochirurgische Klinik

    Mainz, 55131

  • Universitätsklinikum Mannheim, I. Med. Klinik

    Mannheim, 68167

  • Klinikum der Philipps-Universität Marburg, Intensivstation III

    Marburg, 35033

  • Klinikum der Univ. München Großhadern, Anaesthesiologische Intensivstation

    München, 81377

  • Klinikum der Univ. München Großhadern

    München, 81377

  • Ludwig Maximilians Universität München, Großhadern, Neurologie-Intensiv

    München, 81377

  • University Hospital, Anaesthesiology

    Tübingen, Baden-Wurttemberg, 72076

  • Berufsgenossenschaftliche Klinik Tuebingen, Intensive care Unit

    Tübingen, 72076

  • Intensive Care Unit of the Internal Department, Universitiy of Tuebingen

    Tübingen, 72076

Other trials in Germany

About this study

Official title: Beatmungsdauer Und Lungenfunktion Bei Beatmeten Patienten Unter Therapie Mit Dornase Alfa - Randomisierte, Doppel-Blinde, Placebo-Kontrollierte, Multizentrische, Prospektive Klinische Studie

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

Read the detailed 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).

Being tested
dornase alfa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dornase alfaDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time of mechanical ventilation from beginning of the ventilation-therapy up to the end of the ventilation-therapy

Secondary outcomes (6)

  1. reduction of atelectasis / dystelectasis

  2. improval of pulmonaryfunction

  3. reduction of pneumonia

  4. reduction of DNA concentrations in Airway Secretions

  5. length of stay at the Intensive Care Unit

  6. length of stay at the hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startAug 2003
  3. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
540 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00204685
Sponsor's protocol ID
LUFIT
Status last verified
Sep 2006
First submitted
9 Sep 2005
Last updated
14 Sep 2006
Results posted
No

Publications

  • Aitken ML, Burke W, McDonald G, Shak S, Montgomery AB, Smith A. Recombinant human DNase inhalation in normal subjects and patients with cystic fibrosis. A phase 1 study. JAMA. 1992 Apr 8;267(14):1947-51.

    PubMed 1548827

  • Harms HK, Matouk E, Tournier G, von der Hardt H, Weller PH, Romano L, Heijerman HG, FitzGerald MX, Richard D, Strandvik B, Kolbe J, Kraemer R, Michalsen H. Multicenter, open-label study of recombinant human DNase in cystic fibrosis patients with moderate lung disease. DNase International Study Group. Pediatr Pulmonol. 1998 Sep;26(3):155-61. doi: 10.1002/(sici)1099-0496(199809)26:33.0.co;2-k.

    PubMed 9773909

  • King M, Dasgupta B, Tomkiewicz RP, Brown NE. Rheology of cystic fibrosis sputum after in vitro treatment with hypertonic saline alone and in combination with recombinant human deoxyribonuclease I. Am J Respir Crit Care Med. 1997 Jul;156(1):173-7. doi: 10.1164/ajrccm.156.1.9512074.

    PubMed 9230743

  • Rochat T, Pastore FD, Schlegel-Haueter SE, Filthuth I, Auckenthaler R, Belli D, Suter S. Aerosolized rhDNase in cystic fibrosis: effect on leucocyte proteases in sputum. Eur Respir J. 1996 Nov;9(11):2200-6. doi: 10.1183/09031936.96.09112200.

    PubMed 8947060

  • Dasgupta B, King M. Reduction in viscoelasticity in cystic fibrosis sputum in vitro using combined treatment with nacystelyn and rhDNase. Pediatr Pulmonol. 1996 Sep;22(3):161-6. doi: 10.1002/(SICI)1099-0496(199609)22:33.0.CO;2-S.

    PubMed 8893254

  • Puchelle E, Zahm JM, de Bentzmann S, Grosskopf C, Shak S, Mougel D, Polu JM. Effects of rhDNase on purulent airway secretions in chronic bronchitis. Eur Respir J. 1996 Apr;9(4):765-9. doi: 10.1183/09031936.96.09040769.

    PubMed 8726943

  • Desai M, Weller PH, Spencer DA. Clinical benefit from nebulized human recombinant DNase in Kartagener's syndrome. Pediatr Pulmonol. 1995 Nov;20(5):307-8. doi: 10.1002/ppul.1950200509.

    PubMed 8903903

  • Touleimat BA, Conoscenti CS, Fine JM. Recombinant human DNase in management of lobar atelectasis due to retained secretions. Thorax. 1995 Dec;50(12):1319-21; discussion 1323. doi: 10.1136/thx.50.12.1319.

    PubMed 8553310

  • Wills PJ, Wodehouse T, Corkery K, Mallon K, Wilson R, Cole PJ. Short-term recombinant human DNase in bronchiectasis. Effect on clinical state and in vitro sputum transportability. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):413-7. doi: 10.1164/ajrccm.154.2.8756815.

    PubMed 8756815

  • Boeuf B, Prouix F, Morneau S, Marton D, Lacroix J. Safety of endotracheal rh DNAse (Pulmozyme) for treatment of pulmonary atelectasis in mechanically ventilated children. Pediatr Pulmonol. 1998 Aug;26(2):147. doi: 10.1002/(sici)1099-0496(199808)26:23.0.co;2-1. No abstract available.

    PubMed 9727769

  • Voelker KG, Chetty KG, Mahutte CK. Resolution of recurrent atelectasis in spinal cord injury patients with administration of recombinant human DNase. Intensive Care Med. 1996 Jun;22(6):582-4. doi: 10.1007/BF01708100.

    PubMed 8814475

  • Shah PL, Scott SF, Knight RA, Marriott C, Ranasinha C, Hodson ME. In vivo effects of recombinant human DNase I on sputum in patients with cystic fibrosis. Thorax. 1996 Feb;51(2):119-25. doi: 10.1136/thx.51.2.119.

    PubMed 8711640

  • Shah PL, Hodson ME. New treatment strategies in cystic fibrosis: rhDNase. Monaldi Arch Chest Dis. 1996 Apr;51(2):125-9.

    PubMed 8680379

  • Bates RD, Nahata MC. Aerosolized dornase alpha (rhDNase) in cystic fibrosis. J Clin Pharm Ther. 1995 Dec;20(6):313-5. doi: 10.1111/j.1365-2710.1995.tb00703.x.

    PubMed 8847368

  • Reiter PD, Townsend SF, Velasquez R. Dornase alfa in premature infants with severe respiratory distress and early bronchopulmonary dysplasia. J Perinatol. 2000 Dec;20(8 Pt 1):530-4. doi: 10.1038/sj.jp.7200456. No abstract available.

    PubMed 11190594

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing dornase alfa in people with Long Term Ventilation, run by University Hospital Tuebingen at 25 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Time of mechanical ventilation from beginning of the ventilation-therapy up to the end of the ventilation-therapy. 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 NCT00204685, which also lists 23 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 14 Sep 2006.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in