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	EUCTR2013-005481-19-DK (EUCTR)	27/05/2014	27/05/2014	High Dose Antioxidant Treatment for Patients with Cystic Fibrosis	High Dose Antioxidant Treatment for Patients with Cystic Fibrosis	Cystic Fibrosis MedDRA version: 17.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Mucolysin INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: ACETYLCYSTEINE Trade Name: Mucomyst INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: ACETYLCYSTEINE Trade Name: ACC INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: ACETYLCYSTEINE Trade Name: Tad INN or Proposed INN: GLUTATHIONE Other descriptive name: GLUTATHIONE SODIUM	Aarhus University Hospital	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Denmark
2	NCT00506688 (ClinicalTrials.gov)	July 2007	24/7/2007	Efficacy and Safety Study of Inhaled Glutathione in Cystic Fibrosis Patients	Randomized, Placebo-controlled, Double-blinded Study to Investigate the Efficacy and Safety of a 24-week Inhalation Treatment With Glutathione in Cystic Fibrosis Patients	Cystic Fibrosis	Drug: reduced glutathione sodium salt;Drug: 0.9% normal saline (control)	Mukoviszidose Institut gGmbH	Cystic Fibrosis Foundation Therapeutics	Completed	8 Years	N/A	Both	153	Phase 2	Germany

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

EUCTR2013-005481-19-DK
(EUCTR)

27/05/2014

High Dose Antioxidant Treatment for Patients with Cystic Fibrosis

Cystic Fibrosis
MedDRA version: 17.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Trade Name: Mucolysin
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Trade Name: Mucomyst
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Trade Name: ACC
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Trade Name: Tad
INN or Proposed INN: GLUTATHIONE
Other descriptive name: GLUTATHIONE SODIUM

Aarhus University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Denmark

NCT00506688
(ClinicalTrials.gov)

July 2007

24/7/2007

Efficacy and Safety Study of Inhaled Glutathione in Cystic Fibrosis Patients

Randomized, Placebo-controlled, Double-blinded Study to Investigate the Efficacy and Safety of a 24-week Inhalation Treatment With Glutathione in Cystic Fibrosis Patients

Cystic Fibrosis

Drug: reduced glutathione sodium salt;Drug: 0.9% normal saline (control)

Mukoviszidose Institut gGmbH

Cystic Fibrosis Foundation Therapeutics

Completed

8 Years

N/A

Both

153

Phase 2

Germany