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	1

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	EUCTR2011-002000-32-DE (EUCTR)	13/12/2011	31/10/2011	A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis	A single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis	Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI Podhaler 28 mg Hartkapseln mit Pulver zur Inhalation Product Name: TOBI Podhaler 28 mg Hartkapseln mit Pulver zur Inhalation Product Code: TBM100C INN or Proposed INN: Tobramycin	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 4	France;United States;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy

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

EUCTR2011-002000-32-DE
(EUCTR)

13/12/2011

31/10/2011

A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis

A single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis

Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Trade Name: TOBI Podhaler 28 mg Hartkapseln mit Pulver zur Inhalation
Product Name: TOBI Podhaler 28 mg Hartkapseln mit Pulver zur Inhalation
Product Code: TBM100C
INN or Proposed INN: Tobramycin

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

France;United States;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy