NCT00204685

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
540

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2003

Typical duration for phase_2

Geographic Reach
1 country

25 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

September 14, 2006

Status Verified

September 1, 2006

First QC Date

September 9, 2005

Last Update Submit

September 13, 2006

Conditions

Long Term Ventilation

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

  • reduction of atelectasis / dystelectasis

  • improval of pulmonaryfunction

  • reduction of pneumonia

  • reduction of DNA concentrations in Airway Secretions

  • length of stay at the Intensive Care Unit

  • +1 more secondary outcomes

Interventions

dornase alfaDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

University Hospital, Anaesthesiology

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Charité, Universitätsmedizin Berlin, Campus Mitte, Innere Intensivstation

Berlin, 10117, Germany

Location

Universität Charité, Campus Mitte, Anästhesie, Intensivstation

Berlin, 10117, Germany

Location

Vivantes Klinikum Spandau, Klinik für Anästhesie

Berlin, 13585, Germany

Location

Klinikum Chemnitz gGmbH, Innere Medizin

Chemnitz, 09113, Germany

Location

Universitätsklinikum Erlangen Medizinische Klinik, Intensivstation I

Erlangen, 91054, Germany

Location

Universitätsklinikum, Innere Medizin, Intensivstation

Frankfurt, 60590, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, Medizinische Intensivstation

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover, Anästhesiologie

Hanover, 30625, Germany

Location

Anästhesiolog. Klinik der Ruprecht-Karls-Universität

Heidelberg, 69120, Germany

Location

Universitätsklinikum des Saarlandes, Innere Medizin III, Internistische Intensivstation

Homburg / Saar, 66421, Germany

Location

Klinik für Anästhesiologie u. IntensivtherapieUniversität Leipzig

Leipzig, 04103, Germany

Location

Universitätsklinik Lübeck, Medizinische Klinik 1

Lübeck, 23538, Germany

Location

Department of internal Medicine

Lüdenscheid, 58505, Germany

Location

Universität Magdeburg, Innere Medizin,

Magdeburg, 39120, Germany

Location

Gutenberg-Universität, Anästhesie-Intensivstation

Mainz, 55131, Germany

Location

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

Mainz, 55131, Germany

Location

Johannes-Gutenberg-Universität, Neurochirurgische Klinik

Mainz, 55131, Germany

Location

Universitätsklinikum Mannheim, I. Med. Klinik

Mannheim, 68167, Germany

Location

Klinikum der Philipps-Universität Marburg, Intensivstation III

Marburg, 35033, Germany

Location

Klinikum der Univ. München Großhadern, Anaesthesiologische Intensivstation

München, 81377, Germany

Location

Klinikum der Univ. München Großhadern

München, 81377, Germany

Location

Ludwig Maximilians Universität München, Großhadern, Neurologie-Intensiv

München, 81377, Germany

Location

Berufsgenossenschaftliche Klinik Tuebingen, Intensive care Unit

Tübingen, 72076, Germany

Location

Intensive Care Unit of the Internal Department, Universitiy of Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (24)

  • 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.

    PMID: 1548827BACKGROUND

  • 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.

    PMID: 9773909BACKGROUND

  • 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.

    PMID: 9230743BACKGROUND

  • 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.

    PMID: 8947060BACKGROUND

  • 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.

    PMID: 8893254BACKGROUND

  • 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.

    PMID: 8726943BACKGROUND

  • 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.

    PMID: 8903903BACKGROUND

  • 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.

    PMID: 8553310BACKGROUND

  • 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.

    PMID: 8756815BACKGROUND

  • 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.

    PMID: 9727769BACKGROUND

  • 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.

    PMID: 8814475BACKGROUND

  • 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.

    PMID: 8711640BACKGROUND

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

    PMID: 8680379BACKGROUND

  • 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.

    PMID: 8847368BACKGROUND

  • 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.

    PMID: 11190594BACKGROUND

  • Durward A, Forte V, Shemie SD. Resolution of mucus plugging and atelectasis after intratracheal rhDNase therapy in a mechanically ventilated child with refractory status asthmaticus. Crit Care Med. 2000 Feb;28(2):560-2. doi: 10.1097/00003246-200002000-00045.

    PMID: 10708200BACKGROUND

  • Shah PL, Conway S, Scott SF, Rainisio M, Wildman M, Stableforth D, Hodson ME. A case-controlled study with dornase alfa to evaluate impact on disease progression over a 4-year period. Respiration. 2001;68(2):160-4. doi: 10.1159/000050486.

    PMID: 11287830BACKGROUND

  • Fuchs HJ, Borowitz DS, Christiansen DH, Morris EM, Nash ML, Ramsey BW, Rosenstein BJ, Smith AL, Wohl ME. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. The Pulmozyme Study Group. N Engl J Med. 1994 Sep 8;331(10):637-42. doi: 10.1056/NEJM199409083311003.

    PMID: 7503821BACKGROUND

  • Patel A, Harrison E, Durward A, Murdoch IA. Intratracheal recombinant human deoxyribonuclease in acute life-threatening asthma refractory to conventional treatment. Br J Anaesth. 2000 Apr;84(4):505-7. doi: 10.1093/oxfordjournals.bja.a013479.

    PMID: 10823105BACKGROUND

  • Brandt T, Breitenstein S, von der Hardt H, Tummler B. DNA concentration and length in sputum of patients with cystic fibrosis during inhalation with recombinant human DNase. Thorax. 1995 Aug;50(8):880-2. doi: 10.1136/thx.50.8.880.

    PMID: 7570441BACKGROUND

  • Grassme H, Kirschnek S, Riethmueller J, Riehle A, von Kurthy G, Lang F, Weller M, Gulbins E. CD95/CD95 ligand interactions on epithelial cells in host defense to Pseudomonas aeruginosa. Science. 2000 Oct 20;290(5491):527-30. doi: 10.1126/science.290.5491.527.

    PMID: 11039936BACKGROUND

  • Grassmé H, Kirschnek S, Riethmueller J, Riehle A, v Kürthy G, Lang F, Weller M, Gulbins E. Role of apoptosis in Pseudomonas aeruginosa pneumonia. Science 194, 11/2001: 1783a

    BACKGROUND

  • 24. Riethmueller J, Grassmé H, Ziebach R, Wessels J, Eyrich M, Stern M, Gulbins E. DNA-quantification and -qualification in sputum of CF-patients for monitoring rhDNase-therapy? Journal of Cystic Fibrosis 1. 6/2002: S110

    BACKGROUND

  • Cook DJ, Walter SD, Cook RJ, Griffith LE, Guyatt GH, Leasa D, Jaeschke RZ, Brun-Buisson C. Incidence of and risk factors for ventilator-associated pneumonia in critically ill patients. Ann Intern Med. 1998 Sep 15;129(6):433-40. doi: 10.7326/0003-4819-129-6-199809150-00002.

    PMID: 9735080BACKGROUND

MeSH Terms

Interventions

dornase alfa

Study Officials

  • Joachim Riethmueller, Dr. med.

    University Children's Hospital Tuebingen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 20, 2005

Study Start

August 1, 2003

Study Completion

July 1, 2006

Last Updated

September 14, 2006

Record last verified: 2006-09

Locations

DE(25)