Dornase alfa ( DrugBank: Dornase alfa )


2 diseases
IDDisease name (Link within this page)Number of trials
53Sjogren syndrome1
299Cystic fibrosis9

53. Sjogren syndrome


Clinical trials : 305 Drugs : 325 - (DrugBank : 104) / Drug target genes : 58 - Drug target pathways : 188
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01357447
(ClinicalTrials.gov)
May 201118/5/2011Pulmozyme for Sjogren's Associated CoughA Double-blind, Placebo-controlled Cross-over Trial of Pulmozyme for Sjogren's Associated CoughSjogren's Syndrome;CoughDrug: Dornase alfa;Drug: SalineUConn HealthNULLWithdrawn18 YearsN/AAll0Phase 1United States

299. Cystic fibrosis


Clinical trials : 1,695 Drugs : 1,527 - (DrugBank : 268) / Drug target genes : 111 - Drug target pathways : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01712334
(ClinicalTrials.gov)
December 201219/10/2012A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic FibrosisA Phase IV Multicenter, Randomized, Open Label, Two-Period, Crossover Study in Patients With Cystic Fibrosis to Evaluate the Comparable Efficacy and Safety of Pulmozyme Delivered by the eRapid Nebulizer SystemCystic FibrosisDrug: dornase alfa [Pulmozyme®]Genentech, Inc.NULLCompleted6 YearsN/AAll99Phase 4United States
2NCT00680316
(ClinicalTrials.gov)
June 200816/5/2008A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic FibrosisA Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme® in 3- to 5-Year-Old Patients With Cystic FibrosisCystic FibrosisDrug: Dornase alfa;Drug: PlaceboGenentech, Inc.NULLTerminated3 Years5 YearsAll3Phase 4United States
3NCT00534079
(ClinicalTrials.gov)
September 200721/9/2007Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic RhinosinusitisNasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis - a Double Blind Placebo-controlled Cross-over, Bicenter, Prospective Clinical StudyCystic Fibrosis;RhinosinusitisDrug: Dornase alfa (Pulmozyme);Drug: isotonic salineUniversity of JenaNULLCompleted5 YearsN/ABoth23Phase 3Germany
4NCT00434278
(ClinicalTrials.gov)
March 200711/2/2007A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung DiseaseCystic FibrosisDrug: Dornase alfa;Drug: placeboGenentech, Inc.NULLTerminated14 YearsN/AAll27Phase 4United States
5NCT00416182
(ClinicalTrials.gov)
December 200626/12/2006Nasally Delivered Pulmozyme for Sinusitis in Cystic FibrosisThe Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot StudySinusitis;Cystic FibrosisDrug: Pulmozyme (dornase alfa);Drug: PlaceboUniversity of VermontGenentech, Inc.Completed5 YearsN/AAll16Phase 2United States
6NCT00265434
(ClinicalTrials.gov)
December 200513/12/2005Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic RhinosinusitisNasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic RhinosinusitisCystic Fibrosis;Chronic RhinosinusitisDrug: PulmozymeUniversity of JenaPD Dr. Joachim Riethmöller, Tübingen;PD Dr. Assen Koitschev, Tübingen;Dr. Gerlind SchneiderCompleted5 YearsN/ABoth5Phase 3Germany
7EUCTR2004-001888-21-GB
(EUCTR)
03/12/200422/02/2005A cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic FibrosisA cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic Fibrosis Cystic fibrosis (CF)Product Name: DP Mannitol
INN or Proposed INN: Mannitol
Trade Name: Pulmozyme (dornase alfa)
Product Name: Pulmozyme (dornase alfa)
INN or Proposed INN: Dornase alfa
Other descriptive name: rhDNAse
Pharmaxis LtdNULLNot Recruiting Female: yes
Male: yes
42 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
8EUCTR2015-003537-99-Outside-EU/EEA
(EUCTR)
05/07/2016A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic FibrosisA PHASE IV MULTICENTER, RANDOMIZED, OPEN LABEL, TWO-PERIOD CROSSOVER STUDY IN PATIENTS WITH CYSTIC FIBROSIS TO EVALUATE THE COMPARABLE EFFICACY AND SAFETY OF PULMOZYME® DELIVERED BY THE ERAPID™ NEBULIZER SYSTEM Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Pulmozyme
Product Name: Pulmozyme
INN or Proposed INN: DORNASE ALFA
F. Hoffmann-La Roche AGNULLNAFemale: yes
Male: yes
80Phase 4United States
9EUCTR2007-001548-36-DE
(EUCTR)
27/07/2009Nasale Inhalation von Pulmozyme bei Patienten mit Mukoviszidose und chronischer Rhinosinusitis mit dem Pari Sinus-Vernebler.- bizentrische, randomisierte, doppel-blinde, placebo-kontrollierte, prospektive klinische Studie -Nasal Inhalation of Dornase alfa (Pulmozyme) in Patients with Cystic Fibrosis and Chronic Rhinosinusitis - pulmozyme-nasal-cfNasale Inhalation von Pulmozyme bei Patienten mit Mukoviszidose und chronischer Rhinosinusitis mit dem Pari Sinus-Vernebler.- bizentrische, randomisierte, doppel-blinde, placebo-kontrollierte, prospektive klinische Studie -Nasal Inhalation of Dornase alfa (Pulmozyme) in Patients with Cystic Fibrosis and Chronic Rhinosinusitis - pulmozyme-nasal-cf Cystic Fibrosis with chronic rhinosinusitisTrade Name: Pulmozyme
Product Name: Pulmozyme
INN or Proposed INN: Dornase alfa
Other descriptive name: recombiant human Desoxyribonuclease ( rhDNase)
University of JenaNULLNot RecruitingFemale: yes
Male: yes
16Phase 3Germany