TOBI 300mg/5mL Nebuliser Solution ( DrugBank: - )


1 disease
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18

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-000441-20-NL
(EUCTR)
11/09/201206/07/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 13.1;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: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom
2EUCTR2011-000441-20-BG
(EUCTR)
13/06/201203/05/2012Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 17.1;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: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Serbia;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
3EUCTR2011-000441-20-IE
(EUCTR)
02/05/201226/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;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: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Code: TOBI
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
4EUCTR2011-000441-20-DK
(EUCTR)
29/03/201222/07/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;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: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
5EUCTR2011-000441-20-BE
(EUCTR)
30/01/201225/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
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: Liposomal Amikacin (Arikace™)
Product Code: N/A
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Name: TOBI
Product Code: N/A
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany
6EUCTR2011-000441-20-DE
(EUCTR)
19/09/201130/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;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: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Name: TOBI
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
7EUCTR2011-000441-20-GB
(EUCTR)
03/08/201124/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
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: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
8EUCTR2011-000441-20-AT
(EUCTR)
19/07/201121/06/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;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: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
9EUCTR2011-000441-20-GR
(EUCTR)
15/07/201122/06/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
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: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
10EUCTR2011-000441-20-SK
(EUCTR)
04/07/201125/11/2014Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 17.1;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: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
11EUCTR2011-000441-20-HU
(EUCTR)
29/06/201120/04/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
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: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
12EUCTR2009-016590-15-GR
(EUCTR)
15/06/201031/12/2009A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10068297;Term: Pseudomonas colonisation
MedDRA version: 12.0;Classification code 10068292;Term: Pseudomonas colonization
Trade Name: TOBI 300mg/5mL nebuliser solution
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
72France;Hungary;Greece;Poland;Germany;Italy
13EUCTR2009-016590-15-FR
(EUCTR)
15/04/201014/12/2009A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10068297;Term: Pseudomonas colonisation
MedDRA version: 12.0;Classification code 10068292;Term: Pseudomonas colonization
Trade Name: TOBI 300mg/5mL nebuliser solution
Product Name: TOBI
INN or Proposed INN: Tobramycin
Trade Name: TOBI 300mg/5mL nebuliser solution
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
72Phase 3France;Hungary;Greece;Poland;Germany;Italy
14EUCTR2006-006215-68-FR
(EUCTR)
21/09/200906/08/2009A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
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: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Phase 3France;Hungary;Czech Republic;Spain;Germany
15EUCTR2006-006215-68-DE
(EUCTR)
14/08/200818/12/2008A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
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: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320France;Hungary;Czech Republic;Spain;Germany
16EUCTR2006-006215-68-HU
(EUCTR)
13/08/200825/06/2008A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
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: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Hungary;Germany;Czech Republic;France;Spain
17EUCTR2006-006215-68-CZ
(EUCTR)
29/07/200816/06/2008A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
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: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Phase 3France;Hungary;Czech Republic;Spain;Germany
18EUCTR2005-003772-37-ES
(EUCTR)
09/02/200620/01/2006A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Greece;Spain;Germany;Italy;United Kingdom