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	5

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2015-003040-39-IT (EUCTR)	14/09/2016	28/09/2018	Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection	A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection - Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder i	Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]	Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA	NOVARTIS PHARMA SERVICES AG	NULL	Not Recruiting	Female: yes Male: yes	180	Phase 2	France;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy
2	EUCTR2011-000441-20-ES (EUCTR)	21/09/2011	11/11/2011	ESTUDIO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA	ESTUDIO ALEATORIZADO, ABIERTO, CONTROLADO CON MEDICAMENTO ACTIVO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA - TR02-108	Infección pulmonar con Pseudomonas aeruginosa/ colonización en pacientes con fibrosis quística MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Amikacina liposomal (Arikace?) INN or Proposed INN: Sulfato de amikacina Trade Name: TOBI 300mg/ 5ml solución para inhalación con nebulizador INN or Proposed INN: tobramicina	Insmed Incorporated	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	300		Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Australia;United Kingdom;Slovakia;Canada;Belgium;Denmark;Spain;United States;Greece;Poland
3	EUCTR2007-004277-26-ES (EUCTR)	25/08/2008	24/01/2008	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística	Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. Pacientes adultos y pediátricos con fibrosis quística (FQ) con infección pulmonar por Pseudomonas aeruginosa (PA). MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis	Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin	Gilead Sciences Inc	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	200	Phase 3	Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
4	EUCTR2006-006215-68-ES (EUCTR)	22/08/2008	27/06/2008	ENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA	ENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA	Infección pulmonar crónica por P. aeruginosa en pacientes con fibrosis quística MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung	Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramicina Trade Name: Tobi 300mg/5ml Solución para inhalación por nebulizador. Product Name: Tobi INN or Proposed INN: tobramycin	Chiesi Farmaceutici S.p.A	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	320		Hungary;Germany;Czech Republic;France;Spain
5	EUCTR2005-003772-37-ES (EUCTR)	09/02/2006	20/01/2006	A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística.	A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística.	Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762	Product Name: Tobramycin Inhalation Powder Product Code: TIP INN or Proposed INN: Tobramycin Trade Name: TOBI 300mg/5mL Nebuliser Solution Product Name: TOBI INN or Proposed INN: Tobramycin	Chiron Corporation Ltd	NULL	Not Recruiting	Female: yes Male: yes	500	Phase 3	Hungary;Greece;Spain;Germany;Italy;United Kingdom

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

EUCTR2015-003040-39-IT
(EUCTR)

14/09/2016

28/09/2018

Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection

A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection - Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder i

Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis
MedDRA version: 20.1;Level: PT;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.1;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE
Product Name: Tobramicina polvere inalatoria
Product Code: TBM100
INN or Proposed INN: TOBRAMICINA
Other descriptive name: TOBRAMICINA
Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE
Product Name: Tobramicina polvere inalatoria
Product Code: TBM100
INN or Proposed INN: TOBRAMICINA
Other descriptive name: TOBRAMICINA
Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE
Product Name: Tobramicina polvere inalatoria
Product Code: TBM100
INN or Proposed INN: TOBRAMICINA
Other descriptive name: TOBRAMICINA

NOVARTIS PHARMA SERVICES AG

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

France;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy

EUCTR2011-000441-20-ES
(EUCTR)

21/09/2011

11/11/2011

ESTUDIO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA

ESTUDIO ALEATORIZADO, ABIERTO, CONTROLADO CON MEDICAMENTO ACTIVO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA - TR02-108

Infección pulmonar con Pseudomonas aeruginosa/ colonización en pacientes con fibrosis quística
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Amikacina liposomal (Arikace?)
INN or Proposed INN: Sulfato de amikacina
Trade Name: TOBI 300mg/ 5ml solución para inhalación con nebulizador
INN or Proposed INN: tobramicina

Insmed Incorporated

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Australia;United Kingdom;Slovakia;Canada;Belgium;Denmark;Spain;United States;Greece;Poland

EUCTR2007-004277-26-ES
(EUCTR)

25/08/2008

24/01/2008

An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística

Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. Pacientes adultos y pediátricos con fibrosis quística (FQ) con infección pulmonar por Pseudomonas aeruginosa (PA).
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis

Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin

Gilead Sciences Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 3

Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria

EUCTR2006-006215-68-ES
(EUCTR)

22/08/2008

27/06/2008

ENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA

Infección pulmonar crónica por P. aeruginosa en pacientes con fibrosis quística
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung

Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramicina
Trade Name: Tobi 300mg/5ml Solución para inhalación por nebulizador.
Product Name: Tobi
INN or Proposed INN: tobramycin

Chiesi Farmaceutici S.p.A

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Hungary;Germany;Czech Republic;France;Spain

EUCTR2005-003772-37-ES
(EUCTR)

09/02/2006

20/01/2006

A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística.

Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
Classification code 10011762

Product Name: Tobramycin Inhalation Powder
Product Code: TIP
INN or Proposed INN: Tobramycin
Trade Name: TOBI 300mg/5mL Nebuliser Solution
Product Name: TOBI
INN or Proposed INN: Tobramycin

Chiron Corporation Ltd

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Hungary;Greece;Spain;Germany;Italy;United Kingdom