DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
299	嚢胞性線維症	3

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT01712334 (ClinicalTrials.gov)	December 2012	19/10/2012	A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis	A 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	Drug: dornase alfa [Pulmozyme®]	Genentech, Inc.	NULL	Completed	6 Years	N/A	All	99	Phase 4	United States
2	NCT00416182 (ClinicalTrials.gov)	December 2006	26/12/2006	Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis	The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study	Sinusitis;Cystic Fibrosis	Drug: Pulmozyme (dornase alfa);Drug: Placebo	University of Vermont	Genentech, Inc.	Completed	5 Years	N/A	All	16	Phase 2	United States
3	EUCTR2015-003537-99-Outside-EU/EEA (EUCTR)		05/07/2016	A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis	A 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 AG	NULL	NA			Female: yes Male: yes	80	Phase 4	United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01712334
(ClinicalTrials.gov)

December 2012

19/10/2012

A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis

A 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

Drug: dornase alfa [Pulmozyme®]

Genentech, Inc.

NULL

Completed

6 Years

N/A

All

Phase 4

United States

NCT00416182
(ClinicalTrials.gov)

December 2006

26/12/2006

Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis

The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study

Sinusitis;Cystic Fibrosis

Drug: Pulmozyme (dornase alfa);Drug: Placebo

University of Vermont

Genentech, Inc.

Completed

5 Years

N/A

All

Phase 2

United States

EUCTR2015-003537-99-Outside-EU/EEA
(EUCTR)

05/07/2016

A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis

A 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 AG

NULL

Female: yes
Male: yes

Phase 4

United States