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	NCT00712166 (ClinicalTrials.gov)	May 2008	7/7/2008	Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa	A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)	Cystic Fibrosis;Lung Infection;Pseudomonas Aeruginosa	Drug: AZLI 75 mg three times daily (TID);Drug: Placebo three times daily (TID)	Gilead Sciences	NULL	Completed	6 Years	N/A	All	160	Phase 3	United States;Australia;Canada

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

NCT00712166
(ClinicalTrials.gov)

May 2008

7/7/2008

Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa

A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)

Cystic Fibrosis;Lung Infection;Pseudomonas Aeruginosa

Drug: AZLI 75 mg three times daily (TID);Drug: Placebo three times daily (TID)

Gilead Sciences

NULL

Completed

6 Years

N/A

All

160

Phase 3

United States;Australia;Canada