DDrare: Database of Drug Development for Rare Diseases

ID	Disease name (Link within this page)	Number of trials
299	Cystic fibrosis	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	EUCTR2008-005080-33-IT (EUCTR)	05/02/2009	19/01/2009	RANDOMIZED, SINGLE BLIND, CONTROLLED TRIAL OF INHALED GLUTATHIONE VERSUS PLACEBO IN PATIENTS WITH CYSTIC FIBROSIS. - INHALED GSH VS PLACEBO IN CYSTIC FIBROSIS	RANDOMIZED, SINGLE BLIND, CONTROLLED TRIAL OF INHALED GLUTATHIONE VERSUS PLACEBO IN PATIENTS WITH CYSTIC FIBROSIS. - INHALED GSH VS PLACEBO IN CYSTIC FIBROSIS	Cystic fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung	Trade Name: TAD 600 INN or Proposed INN: Glutathione	AZIENDA OSPEDALIERA VINCENZO MONALDI DI NAPOLI	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy
2	EUCTR2005-003870-88-DE (EUCTR)	20/10/2006	28/08/2006	Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4	Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4	Cystic fibrosis (CF) is the most common autosomal recessive lethal hereditary disorder in Caucasians. The majority of cystic fibrosis patients die as a result of progressive pulmonary disease. Airway inflammation, characterized by an excessive and persistent neutrophilic infiltration, is key for the pathogenesis of CF lung disease, and ultimately leads to lung destruction.	Product Name: GSH (Glutathione) Product Code: TAD 600 INN or Proposed INN: Glutathione Other descriptive name: reduced glutathione	Mukoviszidose Institut gGmbH i. G.	NULL	Not Recruiting			Female: yes Male: yes	160		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

EUCTR2008-005080-33-IT
(EUCTR)

05/02/2009

19/01/2009

RANDOMIZED, SINGLE BLIND, CONTROLLED TRIAL OF INHALED GLUTATHIONE VERSUS PLACEBO IN PATIENTS WITH CYSTIC FIBROSIS. - INHALED GSH VS PLACEBO IN CYSTIC FIBROSIS

Cystic fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung

Trade Name: TAD 600
INN or Proposed INN: Glutathione

AZIENDA OSPEDALIERA VINCENZO MONALDI DI NAPOLI

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

EUCTR2005-003870-88-DE
(EUCTR)

20/10/2006

28/08/2006

Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4

Cystic fibrosis (CF) is the most common autosomal recessive lethal hereditary disorder in Caucasians. The majority of cystic fibrosis patients die as a result of progressive pulmonary disease. Airway inflammation, characterized by an excessive and persistent neutrophilic infiltration, is key for the pathogenesis of CF lung disease, and ultimately leads to lung destruction.

Product Name: GSH (Glutathione)
Product Code: TAD 600
INN or Proposed INN: Glutathione
Other descriptive name: reduced glutathione

Mukoviszidose Institut gGmbH i. G.

NULL

Not Recruiting

Female: yes
Male: yes

160

Germany