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	NCT01991028 (ClinicalTrials.gov)	April 2014	18/11/2013	A Study to Investigate Lung Deposition of Radiolabelled OligoG	An Open Label, Randomised, Two-way Crossover Scintigraphic Study to Investigate Lung Deposition of Radiolabelled OligoG Delivered as a Dry Powder and as a Nebulised Solution in Cystic Fibrosis Patients	Cystic Fibrosis	Drug: Radiolabelled OligoG CF-5/20 DPI;Drug: Radiolabelled OligoG CF-5/20 6% Solution	Bio-Images Research Ltd	AlgiPharma AS	Completed	18 Years	N/A	Both	10	Phase 2	United Kingdom
2	EUCTR2013-003774-27-GB (EUCTR)	20/01/2014	27/11/2013	A study to investigate lung deposition of radiolabelled OligoG(v1.0)	An open label, randomised, two-way crossover scintigraphic study to investigate lung deposition of radiolabelled OligoG delivered as a dry powder and as a nebulised solution in cystic fibrosis patients - A study to investigate lung deposition of radiolabelled OligoG (v1.0)	Cystic fibrosis (CF) is an autosomal, recessive inheritable disease caused by a homozygote defect at the long arm of Chromosome 7. This mutation causes absence or defect of the cystic fibrosis transmembrane conductance regulator, an ion channel transporting chloride and bicarbonate ions across the cell membrane in exocrine glands. Decreased chloride transport leads to dehydration of the mucus layer, and decreased bicarbonate to increased mucus adhesion. Mucus stagnation results.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Radiolabelled OligoG CF-5/20 Dry Powder for Inhalation (DPI) INN or Proposed INN: OligoG Product Name: Radiolabelled OligoG CF-5/20 6% Solution for Nebulisation INN or Proposed INN: OligoG	AlgiPharma AS	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 2	United Kingdom

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

NCT01991028
(ClinicalTrials.gov)

April 2014

18/11/2013

A Study to Investigate Lung Deposition of Radiolabelled OligoG

An Open Label, Randomised, Two-way Crossover Scintigraphic Study to Investigate Lung Deposition of Radiolabelled OligoG Delivered as a Dry Powder and as a Nebulised Solution in Cystic Fibrosis Patients

Cystic Fibrosis

Drug: Radiolabelled OligoG CF-5/20 DPI;Drug: Radiolabelled OligoG CF-5/20 6% Solution

Bio-Images Research Ltd

AlgiPharma AS

Completed

18 Years

N/A

Both

Phase 2

United Kingdom

EUCTR2013-003774-27-GB
(EUCTR)

20/01/2014

27/11/2013

A study to investigate lung deposition of radiolabelled OligoG(v1.0)

An open label, randomised, two-way crossover scintigraphic study to investigate lung deposition of radiolabelled OligoG delivered as a dry powder and as a nebulised solution in cystic fibrosis patients - A study to investigate lung deposition of radiolabelled OligoG (v1.0)

Cystic fibrosis (CF) is an autosomal, recessive inheritable disease caused by a homozygote defect at the long arm of Chromosome 7. This mutation causes absence or defect of the cystic fibrosis transmembrane conductance regulator, an ion channel transporting chloride and bicarbonate ions across the cell membrane in exocrine glands. Decreased chloride transport leads to dehydration of the mucus layer, and decreased bicarbonate to increased mucus adhesion. Mucus stagnation results.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Radiolabelled OligoG CF-5/20 Dry Powder for Inhalation (DPI)
INN or Proposed INN: OligoG
Product Name: Radiolabelled OligoG CF-5/20 6% Solution for Nebulisation
INN or Proposed INN: OligoG

AlgiPharma AS

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom