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	EUCTR2011-006171-19-IT (EUCTR)	27/10/2011	13/01/2012	Multicentric and randomized study to evaluate the effectiveness of the association of the 2 different treatments in the early P.aerugionsa infection in patient with cystic fibrosis disease. The study will enlist pazients over 5 years old.	randomized multicentric clinical trial upon efficacy of two different drugs combination to eradication of early p.aeruginosa infection in cystic fibrosis patients over 5 years old.	Cystic fibrosis patients with early P.aeruginosa infection. MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: CIPROXIN6CPR RIV 500MG INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE Trade Name: BRAMITOBNEBUL 56F 300MG/4ML INN or Proposed INN: TOBRAMYCIN Trade Name: CIPROXIN6CPR RIV 500MG INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE Trade Name: PROMIXINNEBUL 30MONOD 1MUI INN or Proposed INN: COLISTIN MESILATE SODIUM	AZIENDA OSPEDALIERA MEYER	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			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

EUCTR2011-006171-19-IT
(EUCTR)

27/10/2011

13/01/2012

Multicentric and randomized study to evaluate the effectiveness of the association of the 2 different treatments in the early P.aerugionsa infection in patient with cystic fibrosis disease. The study will enlist pazients over 5 years old.

randomized multicentric clinical trial upon efficacy of two different drugs combination to eradication of early p.aeruginosa infection in cystic fibrosis patients over 5 years old.

Cystic fibrosis patients with early P.aeruginosa infection.
MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Trade Name: CIPROXIN*6CPR RIV 500MG
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Trade Name: BRAMITOB*NEBUL 56F 300MG/4ML
INN or Proposed INN: TOBRAMYCIN
Trade Name: CIPROXIN*6CPR RIV 500MG
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Trade Name: PROMIXIN*NEBUL 30MONOD 1MUI
INN or Proposed INN: COLISTIN MESILATE SODIUM

AZIENDA OSPEDALIERA MEYER

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy