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	2

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	EUCTR2015-004143-39-DK (EUCTR)	14/02/2017	25/10/2016	Saline Hypertonic in Preschoolers with cystic fibrosis and lung structure asmeasured by computedtomography (CT). SHIP-CT study.	A Phase 3 randomised, double-blind, controlled trial of inhaled 7%hypertonic saline versus0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6years of age inparallel with the North American SHIP clinical trial - Ship-CT study	Cystic fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]	Product Name: Hypertonic saline INN or Proposed INN: sodium chloride 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline 0.9% INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%	Erasmus MC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 3	United States;Australia;Denmark;Netherlands
2	NCT02276898 (ClinicalTrials.gov)	November 2011	22/10/2014	A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index	A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index as a Short-term Pharmacodynamic Biomarker in Patients With Cystic Fibrosis.	Cystic Fibrosis	Drug: Hypertonic Saline 7%;Drug: Isotonic Saline 0.9% (Placebo)	The Hospital for Sick Children	NULL	Completed	6 Years	18 Years	Both	24	Phase 2	Canada

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

EUCTR2015-004143-39-DK
(EUCTR)

14/02/2017

25/10/2016

Saline Hypertonic in Preschoolers with cystic fibrosis and lung structure asmeasured by computedtomography (CT). SHIP-CT study.

A Phase 3 randomised, double-blind, controlled trial of inhaled 7%hypertonic saline versus0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6years of age inparallel with the North American SHIP clinical trial - Ship-CT study

Cystic fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Product Name: Hypertonic saline
INN or Proposed INN: sodium chloride 7%
Other descriptive name: SODIUM CHLORIDE 7%
Product Name: Isotonic saline 0.9%
INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%

Erasmus MC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 3

United States;Australia;Denmark;Netherlands

NCT02276898
(ClinicalTrials.gov)

November 2011

22/10/2014

A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index

A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index as a Short-term Pharmacodynamic Biomarker in Patients With Cystic Fibrosis.

Cystic Fibrosis

Drug: Hypertonic Saline 7%;Drug: Isotonic Saline 0.9% (Placebo)

The Hospital for Sick Children

NULL

Completed

6 Years

18 Years

Both

Phase 2

Canada